PrimeC showed a more than 14-month survival benefit in an ALS trial, according to updated long-term data from NeuroSense Therapeutics Ltd.
NeuroSense Therapeutics Ltd announced updated long-term survival data from its completed Phase 2b PARADIGM clinical trial of its investigational therapy PrimeC in patients with amyotrophic lateral sclerosis (ALS), according to the company.
The analysis showed that patients who received PrimeC continuously during both the double-blind and open-label phases achieved an estimated median survival of 36.3 months, compared with 21.4 months for those initially assigned to placebo, representing a more than 14-month improvement in survival.
After adjusting for baseline risk factors, a statistical model indicated that PrimeC treatment was associated with a 65 per cent reduction in the risk of death compared with placebo, reinforcing the magnitude of the observed survival advantage, the company said.
The PARADIGM trial evaluated PrimeC, an investigational extended-release oral formulation combining two existing FDA-approved drugs, in 68 patients with ALS.
The updated survival results build on previously reported evidence of slowed disease progression and a favourable safety and tolerability profile seen in the same study.
NeuroSense stated that these survival findings provide additional clinical context to support advancement of PrimeC into pivotal late-stage development and strengthen its engagement with regulatory authorities.
The therapy remains investigational and has not been approved for marketing.
