Clinical Trials

NeuroSense has announced new statistically significant results from the 12-month analysis of its PAR ADIGM phase 2b study, which assessed PrimeC for the treatment of patients with Amyotrophic Lateral Sclerosis (ALS).

Data from the trial showed a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores as well as in survival rates for subjects being treated with PrimeC compared to those in the placebo group.

There was a 36% improvement in ALSFRS-R scores, as well as a 43% improvement in survival at the 12-mont h analysis compared to those on placebo.

An additional analysis showed a more than 40% improvement for participants on PrimeC compared to placebo, with this analysis showing a 63% improvement in survival rate for PrimeC patients compared to placebo.

Merit Cudkowicz MD MSc, chair of neurolog y and director of the Sean M Healey and AMG Center for ALS at Massachusetts General Hospita l, US, commented: “These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development. The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants further evaluation in a phase 3 trial in an expeditious ma nner.”

Vivian Dror y MD, head of the ALS clinic at Tel Av iv Sourasky Medical Center, added: “The promising results from the 12-mont h PAR ADIGM study highlight the significant potential of PrimeC as a disease-modif ying drug for ALS. These findings underscore the importance of early inter vention, which can lead to more substantial benefits, and prov ide valuable insights that will inform the design of the company's phase 3 study, increasing the likelihood of success.”