PrimeC Long-Term Survival Data to Be Presented at a Leading ALS Scientific Conference

Rhea-AI Summary

NeuroSense (NASDAQ: NRSN) will present long-term survival data from the Phase 2b PARADIGM trial of PrimeC at the MDA Clinical & Scientific Conference on March 9, 2026. The analysis showed a 65% reduction in risk of death (HR 0.35; p=0.0037) and a >14-month median survival benefit (36.3 vs. 21.4 months; log-rank p=0.0218).

The randomized, double-blind, placebo-controlled study enrolled 68 participants (2:1 randomization) with a six-month double-blind period followed by an open-label extension; safety was described as favorable.

Positive

• Survival benefit: hazard ratio 0.35 (65% risk reduction)
• Median survival +14.9 months (36.3 vs. 21.4 months)
• Statistically significant results: Cox p=0.0037; log-rank p=0.0218
• Randomized, double-blind, placebo-controlled Phase 2b design

Negative

• Small sample size: 68 participants limits generalizability
• Long-term outcomes influenced by open-label extension phase
• Phase 3 study still required for regulatory approval

CAMBRIDGE, Mass., March 9, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announced that the recently reported long-term survival data from its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) will be presented at a leading scientific conference on March 9, 2026.

The survival analysis using a Cox proportional hazards model  demonstrated benefit for PrimeC with a statistically significant 65% reduction in risk of death (hazard ratio: 0.35; p=0.0037) after adjusting for baseline risk factors and a greater than 14-month median survival benefit, calculated from the date of randomization (36.3 months vs. 21.4 months; log-rank p=0.0218) according to Kaplan–Meier survival estimates. The data will be presented at The Muscular Dystrophy Association (MDA) Clinical & Scientific Conference (March 9, 2026) during the 'Advancing ALS Therapeutics: Targets, Tools, and Trial Readiness' session.

The data will be presented by Dr. Jinsy Andrews, a recognized leader in ALS clinical research and a member of NeuroSense Scientific Advisory Board (SAB).

"These long-term survival findings from the Phase 2b randomized ALS study, PARADIGM,  represent compelling evidence of a survival benefits," said Dr. Jinsy Andrews. "The favorable safety profile, the long-term survival data, together with recent findings showing that PrimeC regulates iron metabolism and miRNA in ALS, supporting target engagement, strongly reinforce the continued development of PrimeC in ALS. I look forward to sharing these data with the broader scientific community."    

The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study evaluating PrimeC in 68 people living with ALS. Participants were randomized 2:1 to receive PrimeC or placebo during the six-month double-blind period, followed by an open-label extension phase. Baseline characteristics were well-balanced between the two groups. Previously reported results demonstrated statistically significant slowing of disease progression, along with favorable safety and tolerability over 18 months of treatment.

The newly analyzed long-term survival data further strengthen the overall clinical dataset supporting PrimeC and provide additional context as NeuroSense advances regulatory engagement and preparations for the Phase 3 study.

NeuroSense continues active engagement with regulatory authorities to advance PrimeC toward potential marketing authorization.

About NeuroSense

NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD.

About ALS

Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding future development of PrimeC, are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. These risks include the uncertainty regarding outcomes and the timing of current and future clinical trials; the risk the PrimeC will not advance towards later-stage development, timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 7, 2025 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

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SOURCE NeuroSense

FAQ

What did NeuroSense (NRSN) report about PrimeC survival data on March 9, 2026?

PrimeC showed a statistically significant survival benefit with HR 0.35 and p=0.0037. According to the company, Kaplan–Meier estimates indicated a >14-month median survival advantage (36.3 vs. 21.4 months; log-rank p=0.0218).

How large was the PARADIGM Phase 2b trial for PrimeC (NRSN) and what was the design?

PARADIGM enrolled 68 people living with ALS and used 2:1 randomization. According to the company, it was randomized, double-blind, placebo-controlled with a six-month double-blind period and open-label extension.

Were PrimeC safety and tolerability reported in the Phase 2b PARADIGM data for NRSN?

Yes — safety was described as favorable alongside efficacy findings. According to the company, prior 18-month results showed favorable tolerability and no new safety signals in the trial dataset.

What are the statistical highlights of PrimeC survival analysis presented by NRSN?

The Cox model showed HR 0.35 (65% reduction) with p=0.0037 and Kaplan–Meier median survival 36.3 vs. 21.4 months. According to the company, the log-rank test p=0.0218 supports the survival difference.

What are the next steps for PrimeC development after the March 9, 2026 presentation by NRSN?

NeuroSense plans continued regulatory engagement and Phase 3 preparations. According to the company, the long-term survival data will inform regulatory discussions and design of a pivotal Phase 3 study.