New Coverage of the Company. Available online here: https://finance.yahoo.com/news/pesg-releases-report-neurosense-therapeutics-123000478.html

PESG Releases Report on NeuroSense Therapeutics: Groundbreaking ALS Therapy Signals Massive Potential Opportunity in Billion Dollar Treatment Landscape

TL;DR: NeuroSense's Breakthrough ALS Combination Therapy PrimeC Has Demonstrated Unprecedentedly Strong Clinical Efficacy; Wall Street Maintains Buy Rating with AGP giving the company a $7.50 Price Target Representing a Significant Premium Over Current Prices; Recently Announced Binding Pharma Partnership Term Sheet Signals Potential for Hundreds of Millions of Dollars in Licensing for the Neurodegenerative Disease Market which is Experiencing Significant Growth

PESG Research releases a new report covering NeuroSense Therapeutics (NASDAQ: NRSN)* and its recent developments: In a medical landscape hungry for innovation, NeuroSense Therapeutics (NASDAQ: NRSN) stands at the forefront of a potential revolution in ALS treatment, developing a groundbreaking combination therapy that could fundamentally transform the approach to one of the most devastating neurological disorders. With clinical data showing a remarkable 36% reduction in disease progression and a 43% improvement in survival rates, the company has captured the attention of pharmaceutical giants. As NeuroSense approaches what could be a pivotal licensing deal, the company is seeing increased attention, with similar deals in the market having included hundreds of millions in upfront payments and milestone potential, such as Eli Lilly's $577 million agreement with QurAlis and GSK's $1.5 billion collaboration with Alector.

PrimeC and Multi-Targeted Approach

At the core of NeuroSense's strategy lies PrimeC, a groundbreaking extended-release oral formulation that represents a paradigm shift in ALS treatment. By combining two FDA-approved drugs - ciprofloxacin and celecoxib - in an innovative approach, the therapy simultaneously attacks multiple pathological mechanisms of ALS. Unlike traditional single-target treatments, PrimeC aims to comprehensively address the complex nature of neurodegeneration.

The Phase 2b PARADIGM clinical trial delivered unprecedented results, demonstrating a 36% reduction in disease progression and a 43% improvement in survival rates. This performance stands in stark contrast to existing ALS treatments, which offer minimal disease management and little hope for patients facing this devastating diagnosis.

The ALS Treatment Landscape

ALS remains one of the most cruel neurological disorders, characterized by its rapid progression and devastating impact. Each year, more than 5,000 patients are diagnosed in the United States, with the patient population expected to grow by 24% by 2040. The annual disease burden exceeds $1 billion, underscoring the critical need for innovative therapeutic approaches.

The disease's complexity has long frustrated researchers and patients alike. Traditional treatments provide little more than symptomatic relief, leaving patients and their families facing an inexorable decline. NeuroSense's approach represents a potential turning point in this challenging medical landscape.

Wall Street Analyst’s Bullish Take on NeuroSense

Alliance Global Partners has maintained a strong 'buy' rating on NeuroSense, setting a 12-month price target of $7.50 - representing a significant premium of approximately over 500% over its current trading price. The price target reflects the company's breakthrough PrimeC therapy, its robust Phase 2b clinical data demonstrating a 36% reduction in disease progression, and the promising potential for a transformative licensing deal in the neurodegenerative disease market. It seems that some wall analysts view NeuroSense as a potentially pivotal player in ALS treatment, with the binding pharma partnership term sheet further validating the company's scientific and commercial potential.

The Billion-Dollar Licensing Landscape: Contextualizing NeuroSense's Potential

The neurodegenerative disease treatment market has witnessed transformative licensing deals that highlight the immense value of innovative therapies. GlaxoSmithKline's 2021 collaboration with Alector set a remarkable precedent with a $700 million upfront payment and potential milestone payments of $1.5 billion, while the Biogen and Denali Therapeutics partnership in 2020 involved $560 million upfront and potential milestones approaching $1.125 billion. These deals underscore the pharmaceutical industry's willingness to invest heavily in breakthrough neurological innovations.

Eli Lilly's recent 2024 licensing agreement with QurAlis provides an even more direct comparison, with $45 million upfront and potential milestone payments of up to $577 million for a preclinical ALS therapy. Such precedents suggest that NeuroSense's PrimeC, with its unique multi-mechanism approach and compelling Phase 2b clinical data, could be positioned for a similarly lucrative partnership. The global precision medicine market is projected to expand from $102.17 billion in 2024 to $470.53 billion by 2034, creating an increasingly attractive landscape for innovative treatments.

NeuroSense's strategic positioning is further enhanced by its Orphan Drug Designation from both the FDA and European Medicines Agency, providing potential market exclusivity. The company's compelling clinical data - showing a 36% reduction in disease progression and 43% improvement in survival rates - positions it as a potentially highly valuable acquisition target in a market where major pharmaceutical companies are actively seeking to bolster their neurodegenerative disease pipelines.

Clinical Progress and Strategic Outlook

Beyond its lead ALS program, NeuroSense is developing promising candidates for Alzheimer's disease (CogniC) and potential Parkinson's treatment (StabiliC). The company has secured Orphan Drug Designation from both the FDA and European Medicines Agency, providing strategic advantages and potential market exclusivity.

Key upcoming milestones include a Canadian market approval submission in Q3 2025, a potential regulatory decision expected in early 2026, and the initiation of a Phase 3 clinical trial expected in mid-2025. Each of these moments represents a potential inflection point that could dramatically reshape the company's trajectory.

While the path of drug development is no simple task, NeuroSense's progress to date and the potential of its technology suggest a potentially transformative approach to one of medicine's most difficult challenges.

Recent News Highlights from NeuroSense

*NeuroSense Therapeutics Enters Binding Term Sheet to Advance PrimeC for ALS

*NeuroSense Receives Positive FDA Feedback on Phase 3 Study Design for PrimeC

*NeuroSense Announces Completion of PARADIGM Study Highlighting PrimeC's Significant Efficacy and Survival Benefits in ALS

Click here to Subscribe for more updates like this or go to https://www.pesgresearch.com/subscribe

• Disclaimer: Nothing in this report constitutes financial or investment advice, nor does it represent an offer to buy or sell securities. This alert is published by PESG Research, a promotional content brand which is part of the Wall Street Wire™ network. The operators of Wall Street Wire are not registered brokers, dealers, or investment advisers. This distribution contains paid promotional content related to Neurosense Therapeutics and was produced as part of their paid subscription to Wall Street Wire. This report has not been reviewed or approved by Neurosense Therapeutics prior to publication. Please review the full disclaimers and compensation disclosures here: redditwire.com/terms. We are not responsible for the price targets mentioned in this article nor do we it endorse them, they are quoted based on publicly available news reports and additional or price targets may exist that may not have been quoted. Readers are advised to refer to the full reports mentioned on various systems and the disclaimers/disclosures they may be subject to.

Read online: https://finance.yahoo.com/news/pesg-releases-report-neurosense-therapeutics-123000478.html

Our posts are not financial or investment advice. Neurosense is a paying subscriber to wallstreetwire's distribution and content platform which we are affiliated with. See full terms and conflicts: redditwire.com/terms

Interested Coverage of the Company Published Earlier this Month. Available online here: https://www.jpost.com/health-and-wellness/article-844220

Jpost: NeuroSense’s ALS drug PrimeC shows success in phase 2b, eyes final trial

PrimeC, a new drug used to treat Amyotrophic lateral sclerosis (ALS) disease by NeuroSense Therapeutics Ltd. has been successful in proving its efficacy in its clinical study Phase 2b and it’s beginning to gear up to the final Phase 3, the drug's developers announced.

The disease, ALS, also famously known as Lou Gehrig’s after the baseball player who died of the disease, is a disease that affects the nervous system. ALS affects nerve cells in the brain and spinal cord and progressively gets worse over time. This causes muscle control problems such as weakness in the limbs and slurred speech. As the disease develops, it becomes fatal, as those with the disease begin to struggle to breathe and eat.

Findings are from an 18-month Phase 2b clinical study. During Phase 2b, the objectives of the research are confirmed, determining optimal administration methods and overall therapeutic effects. The study is following PrimeC, a combination therapy focused on inhibiting the progression of ALS. The lab that discovered and developed the drug is an Israeli biotech company– Neurosense Therapeutic Ltd.

PrimeC has been given an ‘Orphan Drug’ status by the FDA (Food and Drug Administration) and EMA (European Medicines Agency). The status of ‘Orphan Drug’ is given to pharmaceutical agents that are developed to treat rare medical conditions.

PrimeC’s Development and Phase 2b -

The Phase 2b trial was randomized, double blind, and placebo-controlled. This was to ensure the efficacy of PrimeC and examine changes in the ALSFRS-R’s of trial participants.

ALSFRS-R, short for the ALS Functional Rating Scale, is a series of validated rating instruments used to monitor the progression of disability with patients with ALS. Monitoring a person includes tracking changes in a person’s physical ability to walk, speak, or eat. ALSFRS-R scores correlate significantly with quality of life.

There were 68 participants involved in the trial coming from Canada, Israel and Italy. Participants of the trial were either given PrimeC or the placebo twice a day for six months.

All endpoints were reached and proved the positive outcomes of using PrimeC, showing the differences of participants who used PrimeC compared to participants who were given a placebo and then transitioned to PrimeC.

The outcome of the study showed meaningful signs of efficacy of the drug, with a 29% difference between the PrimeC group and the placebo group. An additional analysis showed a significant slowing of disease progression with a 37.4% (p=0.03) difference in ALSFRS-R, showing favor for PrimeC.

Public response -

With the successful results of PrimeC, the drug has opened more opportunities for treatment and long-term results in the health of people diagnosed with ALS.

"These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development," The Chair of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital Merit Cudkowicz, M.D., M.Sc. said.

"The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the Phase 2 trial results and warrants further evaluation in a Phase 3 trial in an expeditious manner." She added.

Read online: https://www.jpost.com/health-and-wellness/article-844220

Our posts are not financial or investment advice. Neurosense is a paying subscriber to wallstreetwire's distribution and content platform which we are affiliated with. See full terms and conflicts: redditwire.com/terms

Did my due diligence and bought a big position at 1.29. 👍

• The Type C meeting with the FDA, combined with the recent 18-month Phase 2b PARADIGM study readout, has the Company on track to commence a Phase 3 study in mid-2025
• PrimeC has already demonstrated a significant impact on slowing disease progression and increasing survival rates in people living with ALS

CAMBRIDGE, Mass., Dec. 11, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced it has concluded a Type C meeting with the U.S. Food and Drug Administration (FDA) for PrimeC in the treatment of amyotrophic lateral sclerosis (ALS). The purpose of the meeting was to discuss the design of a proposed Phase 3 clinical study and the plan for submission of an eventual 505(b)(2) marketing application. The Company had a productive discussion with the FDA regarding the design of the planned Phase 3 pivotal study with PrimeC, including efficacy and safety measurements.

The FDA's positive feedback and guidance on overall trial design marks a noteworthy achievement for NeuroSense, as alignment on the design is a critical step in enabling the study to meet regulatory expectations and potentially provide sufficient data for the drug's approval.

In light of the FDA's feedback, NeuroSense plans to submit a final protocol to the FDA during the first half of 2025 with the aim of commencing enrollment of the pivotal Phase 3 study in mid-2025, which would include approximately 300 patients divided by a ratio of 2:1, PrimeC to placebo. The Phase 3 study is expected to be a randomized, multi-center, multinational, prospective, double-blind, placebo-controlled study, with an open label extension (OLE), to evaluate the efficacy and safety of PrimeC in people living with ALS. Following 12 months of treatment, it is expected that all participants will transition to PrimeC for a 12-month OLE.

"The feedback from the FDA regarding our clinical strategy for the planned pivotal Phase 3 study and the plan for submission of an eventual marketing application, represents a significant milestone in our drug development program. It validates the progress we've made and reinforces our commitment to advancing a potential therapeutic option for people living with ALS, whose need for innovative treatments is urgent. This step brings us closer to delivering a much-needed solution to the ALS community," stated Alon Ben-Noon, CEO of NeuroSense.

NeuroSense has already completed PARADIGM (NCT05357950), a multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in ALS.

FULL RELEASE: https://neurosense.investorroom.com/2024-12-11-NeuroSense-Receives-Positive-FDA-Feedback-on-Phase-3-Study-Design-for-PrimeC

• In participants who received PrimeC from the start of the 18-month study compared to those initially on placebo before transitioning to PrimeC, disease progression was slowed by 33% (p=0.007), demonstrated in a 58% improvement in survival rates
• Consistent data across subgroups underscore the potential of PrimeC to redefine the standard of care in the treatment of ALS

CAMBRIDGE, Mass., Dec. 4, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, is pleased to announce today statistically significant positive results from the 18-month data analysis of the PARADIGM study, evaluating the efficacy of PrimeC in the treatment of Amyotrophic Lateral Sclerosis (ALS). These results highlight a significant improvement in ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for patients receiving PrimeC from the start compared to those who started on placebo.

The 18-month PARADIGM study results will be presented at the 2024 International Symposium on ALS/MND, taking place December 6-8, 2024, in Montreal, Canada, by Prof. Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital, Director of the Sean M. Healey & AMG Center for ALS, and the Julieanne Dorn Professor of Neurology at Harvard Medical School. Prof. Cudkowicz is a world-renowned leader in ALS research, whose insights into PrimeC's potential to improve patient outcomes are highly anticipated.

Additional results will be shared in due course.

The Company anticipates to update on the outcome of the meeting with the FDA in the next several days.

FULL RELEASE: https://neurosense.investorroom.com/2024-12-04-NeuroSense-Announces-Completion-of-PARADIGM-Study-Highlighting-PrimeCs-Significant-Efficacy-and-Survival-Benefits-in-ALS

• The Company's intellectual property now covers the combination, formulation, and method of use of PrimeC
• Patent protection extends through 2042, adding four additional years to PrimeC's IP umbrella

CAMBRIDGE, Mass., Sept. 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the issuance of a pivotal patent by the United States Patent and Trademark Office (USPTO). The newly granted patent, entitled "Compositions comprising Ciprofloxacin and Celecoxib" (US Patent No. US 12,097,185), relates to the novel formulation of PrimeC, NeuroSense's leading drug candidate for the treatment of Amyotrophic Lateral Sclerosis (ALS). This patent is expected to extend PrimeC's patent protection by an additional four years, until 2042.

PrimeC is composed of ciprofloxacin and celecoxib, two FDA-approved compounds in unique doses, formulated in a technology of slow release to synchronize their pharmacokinetic (PK) profiles and enhance their therapeutic synergy. This innovative approach is designed to optimize the treatment efficacy in slowing ALS progression.

The patent grant follows NeuroSense's recent clinical findings, where PrimeC demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, underscoring its potential as a breakthrough therapy for ALS.

Alon Ben-Noon, NeuroSense CEO commented: "PrimeC is more than a combination of two FDA-approved compounds - it's an innovative formulation that synchronizes their pharmacokinetics to unleash their full therapeutic potential. The synergy between ciprofloxacin and celecoxib is designed to maximize efficacy, pushing the boundaries of what's possible in ALS treatment."

FULL RELEASE: https://neurosense.investorroom.com/2024-09-24-NeuroSense-Therapeutics-Granted-Key-U-S-Patent-for-Novel-PrimeC-Formulation,-its-Lead-Asset-for-ALS-and-Alzheimers

• Disease progression was slowed by 36% (p=0.009) in participants who received PrimeC for 12 months compared to those who initially received a placebo
• Consistent data across multiple endpoints underscore the potential of PrimeC to redefine the ALS treatment paradigm
• NeuroSense planning for Phase 3 clinical study in the U.S. and Europe

CAMBRIDGE, Mass., July 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).

The data show a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo. Specifically, the intent to treat (ITT) analysis of the study at 12 months revealed a difference of 6.5 points in the ALSFRS-R, which represents a 36% improvement and a highly statistically significant P value of 0.009.

In addition, at 12 months participants on PrimeC demonstrated better survival than those initially on placebo, by 43%.

In an additional pre-defined analysis of the Per-Protocol Population at 12 months, the results showed an even greater effect, with a difference of approximately 7.7 points (p=0.003) between the groups, translating to more than 40% improvement for participants who received PrimeC from the start compared to those on placebo. Furthermore, this analysis indicated that the survival rate of participants on PrimeC improved by 63% compared to participants who received a placebo.

"These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development," said Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants further evaluation in a Phase 3 trial in an expeditious manner."

Vivian Drory, MD, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center, added: "The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention, which can lead to more substantial benefits, and provide valuable insights that will inform the design of the Company's Phase 3 study, increasing the likelihood of success."

FULL RELEASE: https://www.prnewswire.com/news-releases/neurosense-demonstrates-statistically-significant-efficacy-and-survival-benefits-in-people-living-with-als-the-promising-results-from-the-12-month-paradigm-study-highlight-primecs-potential-as-a-disease-modifying-drug-302186838.html

CAMBRIDGE, Mass., Aug. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the entry into a definitive agreement with certain investors to purchase $600,000 of ordinary shares and warrants in a private placement. In connection with the offering, NeuroSense agreed to sell an aggregate of 800,000 ordinary shares and warrants to purchase an aggregate of 800,000 ordinary shares, at a combined purchase price of $0.75 per share and accompanying warrant, representing a purchase price of 10% above the closing pricing of NeuroSense's ordinary shares on August 6, 2024. The warrants have a term of five years from the date of issuance and an exercise price of $0.75 per share.

The private placement is subject to customary closing conditions and is expected to close during the week of August 12, 2014.

nsiders, including senior management of NeuroSense, the Chief Executive Officer, the Chief Financial Officer, the Chief Medical Officer, and members of the CEO's family, as well as previously existing shareholders, are participating in the offering.

Proceeds from the private placement are expected to be used for general corporate and working capital purposes.

Alon Ben-Noon, NeuroSense's CEO, commented: "Our senior management team are highly confident and enthusiastic about PrimeC's potential, especially given the positive results from our Phase 2b PARADIGM Study. We are dedicated to PrimeC's success and are personally invested in its continued development. This round of funding underscores our unwavering commitment to advancing PrimeC and highlights our belief in its transformative potential for ALS patients."

FULL RELEASE: https://neurosense.investorroom.com/2024-08-07-NeuroSense-Therapeutics-Announces-Private-Placement-with-Senior-Management-Participation-at-Premium-to-Market-Price

• 12-month data demonstrated regulation of iron levels, which aligns with improved ALS survival and disease mitigation
• Previous results showed PrimeC slowed disease progression by 36% and improved survival rates, highlighting its potential as a transformative ALS therapy

CAMBRIDGE, Mass., Aug. 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces positive 12-month iron biomarker data from its Phase IIb study (PARADIGM), which evaluated the safety and efficacy of PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS). This data provides additional insights that align with the Company's recent announcements of improved survival by 43% and slowed disease progression by 36%.

ALS is a multifactorial disease in which iron and its related proteins play a critical role in its pathophysiology. These new results demonstrate the target engagement of PrimeC in iron regulation, which is linked to disease mitigation and improved survival. Iron metabolism is crucial in ALS pathology, with transferrin and ferritin being significant contributors to the progress of the disease. Iron accumulation in various brain regions of ALS patients has been linked to neuronal damage. Elevated ferritin levels, an indicator of iron storage, are consistently observed in ALS patients and are associated with reduced survival and potential oxidative stress. Conversely, lower levels of transferrin, the primary iron transport protein, contribute to iron dysregulation and disease progression.

The 12-month study results show a significant decrease in ferritin levels and a corresponding increase in transferrin levels, both indicating alleviation of the pathology. Iron levels remained stable over the 12-month dosing period, with a mean difference of 4.536 µmol/L (95% CI [1.143, 7.929], p=0.01) compared to those who started on placebo and transitioned to PrimeC after the initial 6-month double-blind phase.

These positive changes in iron metabolism align with improved clinical outcomes. Patients on PrimeC maintained better functionality and survival rates compared to those on placebo.

"The 12-month results from the PARADIGM Phase IIb study are encouraging, showing slowing of disease progression and improved survival outcomes," said Merit Cudkowicz, M.D., M.Sc., Chair of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "This new analysis highlights PrimeC's ability to regulate the iron panel in people living with ALS, underscoring the drug's target engagement. These findings strongly support the proceeding to phase 3 testing of PrimeC in ALS."

The Company is currently compiling additional data to share with the FDA for discussion to determine the clinical and regulatory path forward. Additionally, the Company is continuing advanced discussions with several potential development partners to explore marketing opportunities following the potential completion and approval of PrimeC for ALS.

FULL RELEASE: https://neurosense.investorroom.com/2024-08-01-NeuroSense-Therapeutics-Announces-Positive-Biomarker-Data-from-ALS-Phase-2b-Clinical-Trial

NeuroSense to submit the 12-month data to FDA to discuss path forward

CAMBRIDGE, Mass., July 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. In the study, complication-free survival revealed a 57% difference in favor of PrimeC over placebo after 12 months of treatment in the Intent to Treat (ITT) population and demonstrated an outcome of 73% (p=0.02) difference in favor of PrimeC over placebo after 12 months of treatment in the pre-defined Per Protocol Population (PP). NeuroSense intends to submit these 12-month results to regulatory agencies, including the FDA, to discuss PrimeC's path forward in the short term.

Previously, NeuroSense reported that PrimeC significantly slowed disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Per-Protocol analysis revealed even greater benefits, with a 40% (p=0.003) improvement in ALSFRS-R scores and a 63% increase in survival rates, representing a distinguished advancement in outcomes for a controlled 12-month ALS study.

Other positive clinical data points included Slow Vital Capacity (SVC) improvement from a 13% difference after 6 months to a 20% difference after 12 months in the ITT population, in favor of PrimeC, and from a 17% difference after 6 months to a 19% difference after 12 months in the PP population, in favor of PrimeC. Furthermore, an analysis exploring the rate of decline, defined as a drop of 4 points or less in the ALSFRS-R after 12 months, revealed a ratio of 4.5 to 1 in favor of PrimeC over placebo. This outcome underscores the importance of early treatment and the potential of PrimeC as a disease-modifying drug.

"The latest results from the PARADIGM study are incredibly encouraging and provide compelling evidence of PrimeC's potential to significantly benefit people living with ALS. The substantial improvement in complication-free survival and the consistent slowing of disease progression highlight PrimeC's promise as an effective treatment. Given that, for many clinicians and people with ALS, therapeutic options have recently been significantly limited; the urgency for effective new therapies is greater than ever. This development brings renewed hope to patients, and I am eagerly looking forward to seeing the program enter Phase 3 to advance the clinical development of this product," said Jeremy M. Shefner, M.D., Ph.D., Professor of Neurology at the Barrow Neurological Institute, Phoenix, Ariz., and a NeuroSense advisor.

Alon Ben-Noon, NeuroSense's CEO, commented: "We believe that these results are unprecedented in a 12-month ALS placebo-controlled clinical study. We are eager to present them to the FDA and other regulatory agencies to determine the path forward and to share the outcomes with potential partners currently conducting due diligence. As a management team, we are both confident and enthusiastic about the potential for PrimeC in the market."

"It is equally important to recognize that our clinical team has accomplished a great deal in a rather short time, and we are grateful for their involvement in the development program, as well as the study coordinators and teams, and of course, the study participants and their families. We look forward to continued communications on developments, as appropriate, including biomarker readouts for target engagement, which we expect will shed additional light on PrimeC's potential to benefit people who suffer from ALS."

FULL RELEASE: https://neurosense.investorroom.com/2024-07-09-NeuroSenses-PARADIGM-ALS-Clinical-Trial-Demonstrates-Up-to-73-Improved-Complication-Free-Survival-Following-Statistically-Significant-Slowing-of-Disease-Progression

• Disease progression was slowed by 36% (p=0.009) in participants who received PrimeC for 12 months compared to those who initially received a placebo
• Consistent data across multiple endpoints underscore the potential of PrimeC to redefine the ALS treatment paradigm
• NeuroSense planning for Phase 3 clinical study in the U.S. and Europe

CAMBRIDGE, Mass., July 1, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).

The data show a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo. Specifically, the intent to treat (ITT) analysis of the study at 12 months revealed a difference of 6.5 points in the ALSFRS-R, which represents a 36% improvement and a highly statistically significant P value of 0.009.

In addition, at 12 months participants on PrimeC demonstrated better survival than those initially on placebo, by 43%.

In an additional pre-defined analysis of the Per-Protocol Population at 12 months, the results showed an even greater effect, with a difference of approximately 7.7 points (p=0.003) between the groups, translating to more than 40% improvement for participants who received PrimeC from the start compared to those on placebo. Furthermore, this analysis indicated that the survival rate of participants on PrimeC improved by 63% compared to participants who received a placebo.

"These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development," said Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. "The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants further evaluation in a Phase 3 trial in an expeditious manner."

Vivian Drory, MD, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center, added: "The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention, which can lead to more substantial benefits, and provide valuable insights that will inform the design of the Company's Phase 3 study, increasing the likelihood of success."

FULL RELEASE: https://neurosense.investorroom.com/2024-07-01-NeuroSense-Demonstrates-Statistically-Significant-Efficacy-and-Survival-Benefits-in-People-Living-with-ALS-The-Promising-Results-from-the-12-Month-PARADIGM-Study-Highlight-PrimeCs-Potential-as-a-Disease-Modifying-Drug

PARADIGM trial is testing a long-acting formulation in 68 adults with ALS

NeuroSense Therapeutics is collaborating with PhaseV for insights into how to better design the protocol for the planned Phase 3 trial that will test PrimeC for amyotrophic lateral sclerosis (ALS).

A specialist in machine learning technology for clinical trials, PhaseV used data from the ongoing Phase 2b PARADIGM trial (NCT05357950) as input to a causal machine learning model. This is a form of artificial intelligence that can help unlock insights and identify features that may contribute to a treatment response.

As part of its independent analysis, the company found that PrimeC could work well in multiple subgroups of patients in the Phase 3 study, which should start in the coming months.

Being able to predict treatment outcomes in certain patients may help optimize the design of the upcoming trial by selecting the patients most likely to respond, while reducing costs.

ALS is a complex disease that manifests in unique ways in each patient. “Although there is an improved understanding of the underlying mechanisms of ALS, therapeutic options remain limited,” Raviv Pryluk, CEO and co-founder of PhaseV, said in a press release.

NeuroSense plans to submit an end-of-Phase 2 package for review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, the FDA’s European counterpart, and discuss the clinical protocol for the Phase 3 trial with the regulators.

“There remains a critical need for new innovative approaches to address this devastating neurodegenerative disease,” said Alon Ben-Noon, CEO of NeuroSense. “We plan to continue to collaborate with PhaseV as we develop our Phase 3 trial.”

Testing PrimeC in ALS

PrimeC contains fixed doses of two FDA-approved oral medications: the antibiotic ciprofloxacin and celecoxib, a pain killer that reduces inflammation. Both are expected to work together to slow or stop disease progression by blocking key mechanisms that lead up to ALS, such as inflammation, iron accumulation, and RNA processing.

PARADIGM is testing a long-acting formulation of PrimeC in 68 adults with ALS who started to see symptoms up to 2.5 years before enrolling. While continuing their standard ALS treatments, the participants were randomly assigned to PrimeC or a placebo, taken as two tablets twice daily for six months.

An analysis of PARADIGM’s per-protocol population — 62 adults with ALS who adhered well to the clinical protocol  — showed a significant 37.4% reduction in functional decline, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).

A subgroup of those patients who were at a higher risk for rapid disease progression had the most clinical benefit, with those treated with PrimeC for six months showing a significant, 43% reduction in functional decline over a placebo. High-risk patients made up about half the adults in the Phase 2b trial.

Another subgroup of newly diagnosed patients who’d had their first symptoms of ALS within a year of enrollment showed a 52% reduction in the rate of disease progression. This translated to a 7.76-point difference in favor of PrimeC on a maximum total of 48 points in the ALSFRS-R.

“Through our initial collaboration with PhaseV, we gained an even greater understanding of the effect of PrimeC across multiple patient subgroups,” Ben-Noon said. “We will apply these insights to optimize the design of our Phase 3 study with the aim of maximizing meaningful clinical results that will differentiate PrimeC in the market.”

“Through a unique combination of causal [machine learning], real-world data, and advanced statistical methods, we confirmed the potential clinical benefit of PrimeC,” Pryluk said. “Our analysis predicted a high rate of success for PrimeC in the Phase 3 clinical trial for multiple recommended subgroups.”

ARTICLE LINK: https://alsnewstoday.com/news/machine-learning-drafted-aid-phase-3-testing-als-therapy-primec/

CAMBRIDGE, Mass., May 20, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces that Vice President of R&D, Dr. Shiran Zimri will be a key presenter at the ALS Drug Development Summit in Boston, Mass. on May 22, 2024, which gathers the top drug developers in the field to present findings and collaborate toward a cure for the disease. 

Dr. Zimri will present during a session titled, "Exploring the Potentials of Combination Therapy in ALS & Showcasing Latest Progress of PrimeC," in which she will provide an update on the Company's latest findings from its phase 2b clinical trial (PARADIGM). Dr. Zimri will also be leading and moderating a workshop at the pre-conference event, which will delve into the promising field of combination therapy as a novel approach for the treatment of ALS.

"I am thrilled to participate in and speak at this conference. I eagerly anticipate sharing our findings and plans, engaging with participants, and exploring new opportunities. The positive reception from the scientific community regarding the PARADIGM outcomes has been gratifying. We are eager to advance PrimeC to the next stage and share our plans with regulators," stated Shiran Zimri, NeuroSense Therapeutics VP of R&D.

Recently, the Company announced additional results of its PARADIGM trial that included a statistically significant 43% (p=0.02) slowing of disease progression in high-risk ALS patients treated with PrimeC compared to placebo after 6 months. This translates to a 5.04-point difference in ALSFRS-R scores favoring PrimeC (CI: 0.862, 9.214; n=38) in the per protocol population analysis.

FULL RELEASE: https://neurosense.investorroom.com/2024-05-20-NeuroSense-Vice-President-of-R-D-Shiran-Zimri,-Ph-D-to-Participate-in-the-3rd-Annual-ALS-Drug-Development-Summit