PrimeC slows ALS progression by 36% in phase 2b trial

Results from the PARADIGM clinical trial have highlighted the effectiveness of PrimeC, a treatment under development by NeuroSense Therapeutics, in significantly slowing the progression of ALS (Amyotrophic Lateral Sclerosis) in patients. The phase 2b clinical trial involved 68 participants living with ALS across Canada, Italy, and Israel, who were monitored over an 18-month period.

Participants who received PrimeC showed a 36% improvement in the rate of disease progression after 12 months compared to those who took a placebo. Moreover, the survival rate among patients treated with PrimeC was 43% higher during the same period. Merit Cudkowicz, Chair of Neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital, stated that these long-term results illustrate a significant slowing of disease progression over time, as measured by the ALSFRS-R scale, the gold standard in ALS drug development.

The success of the trial was further emphasized by the fact that all participants expressed a desire to continue using PrimeC following the study's conclusion. Encouraged by these positive findings, NeuroSense Therapeutics is preparing to initiate a phase 3 clinical trial of PrimeC in both the United States and Europe.

ALS is a debilitating neurodegenerative disease characterized by progressive paralysis, leading to death within a few years of diagnosis. Currently, there is no cure, and existing treatments offer limited management options. The urgency for new treatments is high, and PrimeC's potential, supported by phase 2 trial results, calls for further and expedited evaluation in a phase 3 trial, according to Cudkowicz.

PrimeC is the lead drug candidate for NeuroSense Therapeutics. It is an oral treatment with extended release containing two FDA-approved drugs: ciprofloxacin and celecoxib. This drug combination aims to target multiple aspects of ALS, such as neuronal degeneration, inflammation, iron accumulation, and impaired RNA regulation.

Vivian Drory, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center, remarked that the promising results from the 12-month PARADIGM study underscore PrimeC's potential as a disease-modifying drug for ALS. Drory emphasized the importance of early intervention, which can lead to more substantial benefits, and noted that these findings will provide valuable insights for designing the phase 3 study, thereby increasing its chances of success.