NRSN News & Events

NeuroSense Therapeutics announced the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis, or ALS. The updated analysis, based on extended follow-up, demonstrates a clinically meaningful and statistically significant improvement in overall survival for patients treated with PrimeC, compared to those initially assigned to placebo. According to Kaplan-Meier survival estimates, patients who received PrimeC continuously during both the double-blind and open-label phases achieved an estimated median survival of 36.3 months, compared to 21.4 months for patients initially assigned to placebo during the double-blind phase and crossing over to active treatment during the open label extension. This represents over 14-month improvement and approximately a 70% increase in median survival. The survival benefit was sustained over time, with consistent separation between treatment arms throughout the follow-up period. The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of PrimeC in 68 people living with ALS. Participants were administered PrimeC or placebo at a 2:1 ratio, respectively, for the six-month double-blind part. NeuroSense continues to engage with regulatory authorities regarding the advancement of PrimeC into pivotal late-stage development and believes these findings add important long-term clinical context to previously reported efficacy results.

NeuroSense Therapeutics announced that the Australian Patent Office has granted Australian Patent No. 2022370513, entitled "Compositions Comprising Ciprofloxacin and Celecoxib," representing another strategic step in the continued expansion of the Company's global intellectual property protection for PrimeC. The granted Australian patent, following prior approval of the corresponding U.S. patent (12,097,185), further expands NeuroSense's patent protection across key global markets and reinforces the company's exclusivity strategy for PrimeC, with patent coverage extending through October 2042. NeuroSense continues to strengthen the company's global intellectual property estate and to support the long-term development and potential commercialization of PrimeC in ALS, Alzheimer's disease and other neurodegenerative indications.

NeuroSense files $150M mixed securities shelf

NeuroSense reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's disease. The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified. As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results expected in the first quarter of 2026.