NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) will present new data from its Phase 2b PARADIGM trial of PrimeC, a drug candidate for Amyotrophic Lateral Sclerosis (ALS), at the International Symposium on ALS/MND in Montreal, Canada, December 6-8, 2024. The presentations will include clinical outcomes and biomarker analysis providing insights into PrimeC's efficacy and mechanism of action in treating ALS.
Presentations by Key Opinion Leaders
Prof. Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital and Director of the Sean M. Healey & AMG Center for ALS, will present the latest clinical outcomes from the PARADIGM trial. Her presentation is highly anticipated due to her expertise in ALS research and insights into PrimeC's potential impact on patient outcomes.
Dr. Cristian Lunetta, Director of the Department of Neuromotor Rehabilitation and ALS Unit of Istituti Clinici Scientifici Maugeri IRCCS, Milan, Italy, will share an in-depth analysis of biomarkers from the PARADIGM trial. This data is expected to provide critical insights into PrimeC's mechanism of action and its potential as a breakthrough in ALS treatment strategies.
PARADIGM Trial Details and Results
The PARADIGM trial is a Phase 2b, multinational, randomized, double-blind, placebo-controlled study (NCT05357950) evaluating PrimeC in 68 ALS patients across Canada, Italy, and Israel. A significant 96% of participants completing the initial 6-month double-blind phase opted to continue treatment with PrimeC in a 12-month open-label extension. All participants completing the 18-month treatment have requested to continue PrimeC via an Investigator Initiated Trial.
Top-line analysis of the 6-month double-blind segment showed clinically meaningful efficacy signals, with a 29% difference favoring PrimeC over placebo in the intent-to-treat (ITT) population. Per protocol (PP) analysis revealed a statistically significant 37.4% (p=0.03) difference in ALSFRS-R scores favoring PrimeC versus placebo, indicating a slowing of disease progression. Notably, most patients in both arms were also treated with riluzole, the standard-of-care ALS medication, suggesting PrimeC's benefits extend beyond those of existing treatments.
About PrimeC
PrimeC is an extended-release oral formulation combining ciprofloxacin and celecoxib, both FDA-approved drugs. It is designed to synergistically target key ALS mechanisms, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. PrimeC has received Orphan Drug Designation from both the FDA and the EMA.
ALS Context
ALS is a progressive neurodegenerative disease leading to paralysis and death within 2-5 years of diagnosis. Over 5,000 new cases are diagnosed annually in the U.S., resulting in a $1 billion annual disease burden. The number of people living with ALS in the U.S. and EU is projected to increase by 24% by 2040.
