NeuroSense Therapeutics Ltd. reported that it met its primary safety and tolerability endpoints and achieved secondary clinical efficacy endpoints in the top-line results of its randomized, placebo-controlled, double-blind segment the Company's Phase 2b amyotrophic lateral sclerosis ("ALS") trial of PrimeC ("PARADIGM"). The trial's secondary clinical efficacy outcome measure endpoints included Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised ("ALSFRS-R") and Slow Vital Capacity ("SVC"), a measure of respiratory function. NeuroSense expects to report an additional primary biomarker endpoint of the assessment of ALS hallmarks, TDP-43 and Prostagladin2, to evaluate PrimeC's biological activity, in the first half of 2024 following the completion of the analysis of participants' plasma.

The PARADIGM (NCT05357950) trial is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b clinical trial of PrimeC in ALS. Participants living with ALS in Canada, Italy, and Israel were enrolled and dosed for 6 months after being randomized 2:1 to receive PrimeC or placebo, respectively. After completion of the 6-month double-blind segment, the participants had the option to enroll in a 12-month open label extension (OLE), during which they all receive treatment with PrimeC.

Over the course of 6 months, patients treated with PrimeC experienced a slowing of disease progression, including preserved daily function. The clinical efficacy results showed a 29% difference in favor of PrimeC in ALSFRS-R (p=0.12) and a 13% difference in favor of PrimeC in SVC (p=0.5) based on data from 68 out of 69 patients, due to 1 misdiagnosed participant. These data include 45 patients randomized to the PrimeC arm and 23 patients randomized to the placebo arm, from the 6-month double-blind segment.

The safety and tolerability profile of PrimeC was comparable to the placebo. Nearly all participants, 96%, who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through the 12-month open label extension. To date, all the participants who already completed the 18-month trial have opted to continue treatment of PrimeC by joining a subsequent investigator-initiated trial.

NeuroSense expects to report results from a strategic collaboration with Biogen in January 2024, evaluating the impact of PrimeC on neurofilament levels in participants enrolled in PARADIGM. Upon receipt of results, Biogen has the right of first refusal to co-develop/commercialize PrimeC for the treatment of ALS for a limited time following the results.