ALS treatment PrimeC slows disease progression by 36% phase 2b trial results show
Results from the PARADIGM clinical trial have revealed that PrimeC, a treatment being developed by NeuroSense Therapeutics, was able to significantly slow down disease progression in ALS patients.
The phase 2b clinical trial recruited 68 people living with ALS across Canada, Italy and Israel, who were followed for up to 18 months.
ALS patients treated with PrimeC showed an improvement of 36% in the rate of decline after 12 months, as compared to those who took a placebo. In addition, patients treated with PrimeC had a 43% higher survival rate during the same time period.
"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," said Merit Cudkowicz, chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.
Underscoring the success of the trial, all participants requested to continue taking PrimeC after the study was completed.
Based on these positive results, NeuroSense Therapeutics is planning to start a phase 3 clinical study of PrimeC in the US and Europe.
ALS is a neurodegenerative disease that causes progressive paralysis and eventually death within a few years from receiving a diagnosis. There is currently no cure for the condition and only a handful of approved treatments that can help patients manage the disease.
"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 manner," said Cudkowicz.
PrimeC is NeuroSense Therapeutics’ lead drug candidate. The treatment consists of an oral formulation with extended release that contains two FDA-approved drugs: ciprofloxacin and celecoxib.
The drug combination is designed to target multiple mechanisms of ALS, including the degeneration of neurons, inflammation, iron accumulation and impaired RNA regulation.
"The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS,” said Vivian Drory, Head of the ALS clinic at Tel-Aviv Sourasky Medical Center.
“These findings underscore the importance of early intervention, which can lead to more substantial benefits, and provide valuable insights that will inform the design of the company's phase 3 study, increasing the likelihood of success."
