#United States #Cambridge #ALS #NeuroSense #PrimeC

Significant Breakthrough: NeuroSense's PrimeC in ALS

NeuroSense Therapeutics Ltd., a clinical-stage biotechnology firm, has achieved a major milestone in the treatment of amyotrophic lateral sclerosis (ALS) with its lead drug candidate, PrimeC. Recently disclosed long-term survival data from the PARADIGM Phase 2b clinical trial reveal an impressive 65% reduction in the risk of death for patients utilizing PrimeC. This data sheds light on the potential of PrimeC not just to alleviate symptoms but also to modify the disease's progression.

Unpacking the Results

The recent updates, based on extended follow-up, illustrate a clear benefit of PrimeC over the placebo. Kaplan-Meier survival estimates indicate that participants receiving PrimeC exhibited a median survival of 36.3 months, in contrast to 21.4 months for their counterparts who were initially assigned to a placebo but transitioned to active treatment later. This equates to a substantial improvement of more than 14 months, indicating a roughly 70% increase in median survival among those treated with the drug.

The long-lasting effectiveness of PrimeC was marked by a consistent divergence in survival rates throughout the trial's follow-up period. Furthermore, statistical analysis utilizing a log-rank test confirmed these findings, demonstrating a significant p-value of 0.0218. Moreover, a Cox proportional hazards model reaffirmed PrimeC's association with a 65% decrease in mortality risk, as noted by a hazard ratio of 0.35.

Comments from Leadership

Alon Ben-Noon, the CEO of NeuroSense, articulated his optimism regarding the new findings, stating, “The long-term survival data further validate the magnitude and durability of PrimeC's effect in ALS and reinforce its potential as a disease-modifying therapy.” He emphasized the importance of the substantial reduction in mortality risk and the notable extension in median survival, considering them “clinically meaningful benefits of notable magnitude in ALS.”

Clinical Trial Overview

The PARADIGM Phase 2b trial was designed as a randomized, double-blind, placebo-controlled study, encompassing 68 individuals diagnosed with ALS. Participants were administered PrimeC or a placebo in a 2:1 ratio for six months. Prior reports highlighted PrimeC’s effectiveness in slowing disease progression while boasting favorable safety and tolerability profiles. The recently publicized survival data enriches the existing evidence base surrounding PrimeC's efficacy.

NeuroSense is actively engaging with regulatory authorities to advance PrimeC towards pivotal late-stage development, confident that these findings will bolster its clinical and regulatory strategy moving forward.

About NeuroSense Therapeutics

NeuroSense focuses on addressing the urgent medical needs presented by neurodegenerative diseases, including ALS, Alzheimer’s disease, and Parkinson’s disease. The company strives to develop therapies that represent a departure from existing treatment modalities, targeting multiple biological pathways involved in these conditions.

About PrimeC

Positioned as NeuroSense's flagship candidate, PrimeC is an innovative oral drug that combines two FDA-approved medications: ciprofloxacin and celecoxib. This dual-action formulation aims to address various aspects of ALS and Alzheimer's disease, including neuron degeneration, inflammation, and RNA regulation issues that drive disease progression.

Understanding ALS

ALS is a relentless neurodegenerative disorder characterized by the progressive loss of motor neurons, often leading to paralysis and death within 2-5 years post-diagnosis. In the U.S., over 5,000 new cases are documented annually, leading to a considerable healthcare burden. Without effective treatment options, the demand for breakthroughs like PrimeC only grows, especially as projections forecast a 24% increase in ALS prevalence by 2040 in both the U.S. and the EU.

Overall, NeuroSense's research signifies hope for those affected by ALS and underscores the company's dedication to developing transformative treatments in the realm of neurodegenerative diseases.