NeuroSense Reports 65% Survival Benefit for ALS Drug PrimeC, Secures South Korean Patent

NeuroSense Therapeutics Ltd. has announced statistically significant long-term survival data showing its experimental ALS drug, PrimeC, reduces the risk of death by 65% compared to placebo. The company also confirmed it has received a patent for PrimeC from the South Korean Intellectual Property Office, expanding its global intellectual property protection.

The updated analysis from the Phase 2b PARADIGM trial shows patients treated continuously with PrimeC achieved a median estimated survival of 36.3 months. This compares to 21.4 months for patients initially assigned to placebo during the double-blind phase, representing an improvement of over 14 months and an approximately 70% increase in median survival. A log-rank test confirmed the survival benefit was statistically significant (p = 0.0218). Further analysis using a Cox proportional hazards model showed PrimeC treatment was associated with a 65% reduction in the risk of death compared to placebo (hazard ratio: 0.35; 95% CI: 0.17–0.71; p = 0.0037) after adjusting for baseline risk factors. The PARADIGM trial was a randomized, double-blind, placebo-controlled study that enrolled 68 people with ALS.

Concurrently, the company announced that the Korean Intellectual Property Office has issued Korean Patent Number 10-2969898 covering the composition of PrimeC. The granted patent claims cover PrimeC's proprietary tablet formulation, manufacturing process, pharmacokinetic characteristics, and pharmaceutical use for the treatment of ALS. The patent is expected to provide protection for these aspects of PrimeC in South Korea through 2042. This grant follows recent patent advancements in Japan, Brazil, Australia, and the United States.

PrimeC is a novel extended-release oral therapy designed to simultaneously target multiple biological mechanisms associated with ALS progression, including neuroinflammation, oxidative stress, and dysregulated iron metabolism. It is a fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 PARAGON study in ALS, which is expected to enroll approximately 300 participants, primarily in the United States.

ALS is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. More than 5,000 people are diagnosed with ALS in the U.S. alone each year, 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. The company's CEO stated that the long-term survival data further validate the magnitude and durability of PrimeC's effect and reinforce its potential as a disease-modifying therapy.