NeuroSense Receives FDA Clearance to Initiate Pivotal Phase 3 Trial for PrimeC in ALS

Rhea-AI Summary

NeuroSense (Nasdaq: NRSN) announced that the U.S. Food and Drug Administration completed review of its IND amendment and authorized initiation of the pivotal Phase 3 trial PARAGON evaluating PrimeC in amyotrophic lateral sclerosis (ALS) on Nov 24, 2025. PARAGON is planned as a global, double-blind, 12-month, placebo-controlled study with 300 participants randomized 2:1 (PrimeC:placebo), an open-label extension, an adaptive design with interim analyses, and is powered at >95% for its primary endpoint. NeuroSense aims to enroll the first patient in the coming months subject to securing strategic resources. Additional trial details and timelines will be presented at an investor webinar on Dec 8, 2025.

Positive

• FDA cleared IND amendment to start Phase 3
• PARAGON powered at >95% for primary endpoint
• Phase 2b showed promising clinical and biomarker outcomes with favorable safety
• 300-patient global randomized 2:1 design with 12-month placebo control

Negative

• First patient enrollment contingent on securing strategic resources, risking delays
• Adaptive design includes futility boundaries that could stop the trial early

Insights

Clinical Development Strategist

FDA cleared the IND amendment allowing initiation of a pivotal Phase 3 (PARAGON) for PrimeC in ALS; first-patient enrollment planned in the coming months.

NeuroSense received FDA clearance on Nov 24, 2025 to start the pivotal Phase 3 trial, PARAGON, for PrimeC in amyotrophic lateral sclerosis. The trial is described as global, randomized 2:1 (PrimeC:Placebo), double-blind, placebo-controlled for 12-month treatment with an open-label extension, and is powered at over 95% for its primary endpoint with an initial target of 300 participants.

The program's immediate operational dependency is securing the "strategic resources" required to launch and enroll the first patient in the coming months; timelines also hinge on planned U.S./EU conduct and the trial's adaptive design that allows interim analyses for sample-size optimization and futility/efficacy checks. Key risks shown in the release include reliance on resource mobilization before initiation and the implicit need to meet predefined interim boundaries to proceed as planned.

Concrete near-term items to watch are: enrollment of the first patient ("coming months"), details and any changes to PARAGON's adaptive rules and sample-size after interim looks, and the investor webinar on Dec 8, 2025 where additional design and timeline specifics will be provided.

CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).

With the FDA's clearance, NeuroSense is preparing for trial initiation and aims to have its first patient enrolled in the coming months upon securing the strategic resources needed to launch the trial.

The global pivotal Phase 3 trial, PARAGON, is powered at over 95% to achieve its primary endpoint and to expand upon the results of NeuroSense's Phase 2b PARADIGM trial, which demonstrated promising clinical and biomarker outcomes and a favorable safety and tolerability profile.

"This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We believe this progress lays a strong foundation for additional achievements across several fronts in the near future," stated Alon Ben-Noon, Chief Executive Officer of NeuroSense. "We recognize the significant unmet need of people living with ALS and remain committed to delivering a meaningful therapy through our efforts." 

Based on prior successful discussions with the FDA and in line with its recent comments and recommendations, PARAGON is expected to be conducted in the U.S. and EU and include 300 people living with ALS randomized in a ratio of 2:1 (PrimeC : Placebo). The prospective, double-blind, 12-month placebo-controlled trial, has an open label extension to evaluate safety and efficacy of PrimeC. The trial will employ an adaptive design allowing for interim analyses to optimize sample size and assess early efficacy and futility boundaries.

Additional details regarding the PARAGON trial design and timelines will be provided in NeuroSense's upcoming investor webinar on December 8^th, 2025 and on NeuroSense's website. Registration to the webinar is available here.

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.

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 Alzheimer's Disease (AD) that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD.

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.

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 commencement of the Phase 3 trial. Further, certain forward-looking statements 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 risk that the Phase 3 trial for PrimeC in ALS will not occur, or if it occurs, will be delayed; that the trial will not be successful; uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; 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) announce on November 24, 2025 about PrimeC?

NeuroSense announced FDA clearance of an IND amendment authorizing initiation of the pivotal Phase 3 PARAGON trial for PrimeC in ALS.

How many patients will be enrolled in NeuroSense's PARAGON Phase 3 trial (NRSN)?

PARAGON is planned to enroll 300 people living with ALS, randomized 2:1 (PrimeC:placebo).

When does NeuroSense expect to enroll the first patient in the Phase 3 PARAGON trial?

NeuroSense aims to enroll the first patient in the coming months, subject to securing required strategic resources.

What is the design and duration of NeuroSense's Phase 3 PARAGON trial (NRSN)?

PARAGON is a prospective, double-blind, 12-month placebo-controlled trial with an open-label extension and an adaptive design with interim analyses.

What statistical power does PARAGON have for its primary endpoint?

PARAGON is powered at over 95% to achieve its primary endpoint.

When will NeuroSense provide more PARAGON trial details and timelines?

Additional details and timelines will be provided at an investor webinar on December 8, 2025 and on NeuroSense's website.