Positive topline data reported in phase 2b trial of oral, fixed-dose ALS drug
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A company specializing in treatment for neurodegenerative diseases announced positive topline data from a phase 2b clinical trial of a novel, extended release oral fixed-dose therapeutic to treat amyotrophic lateral sclerosis.
According to a release from NeuroSense Therapeutics Ltd., the study met its primary safety and tolerability endpoints as well as secondary clinical efficacy endpoints in the prospective, global, randomized, placebo-controlled, double-blind segment of the PARADIGM trial.
Participants were enrolled and randomized 2:1 to receive PrimeC (ciproflaxin and celecoxib) or placebo for 6 months. After completion of the 6-month double-blind segment, enrollees could continue in a 12-month open label extension, during which they all received treatment with PrimeC, the company stated in the release. At 6 months, patients treated with PrimeC experienced a slowing of disease progression, including preserved daily function, with data showing a 29% difference in favor of PrimeC in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale and a 13% difference in favor of PrimeC in slow vital capacity based on data from 68 of 69 individuals.
The safety and tolerability profile of PrimeC was comparable to the placebo, per the release.
“The clinical advancement of a new therapy that helps slow down the progression of ALS, with the potential to preserve quality of life, has the capacity to significantly positively impact people living with ALS and their families,” Merit Cudkowicz, MD, chair of neurology at Massachusetts General Hospital, and member of NeuroSense's scientific advisory board, said in the release. “I am excited by the topline clinical data from PARADIGM, as this is an important milestone for the patients I care for and for the entire ALS community.”
NeuroSense anticipates reporting the results from a strategic collaboration with Biogen in January, evaluating the impact of PrimeC on neurofilament levels from participants in PARADIGM, per the release.