PrimeC shows statistically significant 18‑month ALS benefit for early treatment

Rhea-AI Filing Summary

NeuroSense reported a statistically significant clinical benefit for PrimeC at 18 months. An NfL-adjusted MMRM analysis showed a p=0.03 result, corresponding to a 28% relative difference in decline on the ALS Functional Rating Scale-Revised (ALSFRS-R) favoring patients who received PrimeC from study start versus those who began with placebo and switched to PrimeC after six months. The company states these data underscore the clinical importance of initiating PrimeC early in disease progression.

Positive

• Statistically significant result at 18 months with p=0.03 reported
• 28% relative difference in ALSFRS-R decline favoring immediate PrimeC treatment
• Comparison includes delayed-treatment control (placebo then PrimeC after six months), supporting benefit of earlier initiation

Negative

• None.

Insights

Clinical Neurology Researcher

TL;DR: NfL-adjusted MMRM shows a statistically significant 28% slower ALSFRS-R decline at 18 months (p=0.03) with early PrimeC.

The reported NfL-adjusted mixed-model repeated measures analysis yields a p-value of 0.03 at 18 months, indicating statistical significance by conventional thresholds. The magnitude — a 28% relative difference in ALSFRS-R decline — is a clinically meaningful measure for a progressive neurodegenerative disease like ALS, and the comparison explicitly contrasts immediate treatment versus delayed (placebo for six months) initiation. The brief text does not provide absolute score changes, confidence intervals, sample size, safety data, or subgroup details, so assessment of robustness, generalizability, and clinical relevance beyond the stated relative difference is limited by missing details.

Biotech Financial Analyst

TL;DR: Positive efficacy signal at 18 months may materially affect NeuroSense's development value if confirmed with full data.

The filing highlights a statistically significant efficacy signal (p=0.03) and quantifies a 28% relative benefit on ALSFRS-R for early treatment with PrimeC versus delayed treatment. This is presented as evidence supporting early initiation. The disclosure lacks enrollment numbers, statistical power, regulatory context, and safety or durability data, preventing a complete evaluation of commercial or regulatory impact from this excerpt alone.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of September 2025

Commission File Number: 001-41084

NeuroSense Therapeutics Ltd.

(Translation of registrant’s name into English)

11 HaMenofim Street, Building B
Herzliya 4672562 Israel
+972-9-7996183
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒     Form 40-F ☐

NeuroSense Therapeutics Ltd. today announced a new analysis of 18-month data from its Phase 2b PARADIGM study of PrimeC in ALS.

● Statistically significant effect at 18 months (p=0.03) demonstrated by NfL-adjusted MMRM analysis

● This was reflected in 28% relative difference in ALS Functional Rating Scale-Revised (ALSFRS-R) decline favoring patients who received PrimeC from the beginning of the study versus patients who started the trial with placebo and received PrimeC after six months

● Data underscore the clinical importance of initiating PrimeC early in disease progression

The analysis, adjusted for baseline neurofilament light (NfL, a biomarker of disease aggressiveness), confirms that the observed benefit is consistent after accounting for patient variability.

These results show a clear, statistically validated separation in functional outcomes, reinforcing PrimeC’s potential as a disease-modifying therapy for ALS.

This Report on Form 6-K is hereby incorporated by reference into registrant’s Registration Statements on Form S-8 (File No. 333-262480) and Form F-3 (File No. 333-269306, 333-260338, 333-283656 and 333-284051), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.”

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	NeuroSense Therapeutics Ltd.
Date: September 2, 2025	By:	/s/ Alon Ben-Noon
		Alon Ben-Noon
		Chief Executive Officer

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FAQ

What efficacy result did NeuroSense (NRSN) report for PrimeC?

The company reported a statistically significant effect at 18 months with p=0.03 using an NfL-adjusted MMRM analysis.

How large was the treatment effect on ALSFRS-R reported by NeuroSense?

NeuroSense reported a 28% relative difference in ALSFRS-R decline favoring patients who received PrimeC from study start versus those who started on placebo and switched after six months.

Did the filing describe the trial comparator or design detail?

The filing states patients who began on placebo switched to PrimeC after six months, and compares them to patients who received PrimeC from the beginning; no further design details are provided in the excerpt.

Does the document provide safety or sample size information?

No. The excerpt does not include any safety data, sample sizes, confidence intervals, or other statistical details beyond the p-value and relative difference.

What conclusion does NeuroSense draw from these data?

The company states the data underscore the clinical importance of initiating PrimeC early in disease progression.