Cohortias – FDA grants clearance for Phase IIb ALS trial.

The trial is designed to evaluate the efficacy, safety, and tolerability of PrimeC in ALS patients.
trial

FDA grants clearance for Phase IIb ALS trial

The US Food and Drug Administration (FDA) has granted clearance for NeuroSense Therapeutics’ Investigational New Drug (IND) application to enroll patients in the country in its Phase IIb PARADIGM clinical trial of its PrimeC drug candidate to treat amyotrophic lateral sclerosis (ALS). 

The placebo-controlled, double-blind, multinational trial is designed to evaluate the efficacy, safety, and tolerability of PrimeC in ALS patients. 

It is enrolling and randomizing 69 ALS patients into a 2:1 ratio to receive either PrimeC or a placebo. 

The participants will also be allowed to take standard-of-care (SOC) treatment using approved products. 

Evaluating ALS-biomarkers, clinical efficacy, and improvement in quality of life are included as the primary and secondary endpoints of the trial.

trial

A lead drug candidate of the company, PrimeC is a fixed-dose combination of two drugs, ciprofloxacin and celecoxib, which are approved by the FDA.

The extended-release oral formulation can act on various crucial ALS mechanisms that lead to motor neuron degeneration, inflammation, the build-up of iron, and impaired ribonucleic acid (RNA) regulation to hinder disease progression. 

According to data from a concluded Phase IIa trial, PrimeC met the safety and efficacy endpoints, including lowering functional and respiratory decline.

It also offered statistically significant changes in ALS-associated biological markers, indicating the biological activity of PrimeC. 

In April this year, the company dosed the first healthy subject in the pharmacokinetic study of PrimeC to treat ALS.

Share:

More Posts

Send Us A Message