The US Food and Drug Administration (FDA) has granted clearance for Neurosense Therapeutics’ Investigational New Drug (IND) application to enrol patients in the country in its Phase IIb PARADIGM clinical trial of its PrimeC drug candidate to treat amyotrophic lateral sclerosis (ALS ).
The company anticipates enrolling and dosing the first US subjects at ALS centres soon.
At present, the trial is enrolling subjects in Israel, and the company anticipates launching trial sites for participant recruitment in the European Union soon.
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 randomising 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.
The findings from the trial are anticipated during mid-next year.
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.
NeuroSense CEO Alon Ben-Noon said: “[The] FDA’s acceptance of our IND paves the way for NeuroSense to commence patient enrolment in the US and is another significant milestone achieved in our drug development plan.
“This clinical trial is evaluating our new and improved extended release formulation of PrimeC, which may provide a better outcome than already observed in our prior Phase IIa study.”
In April this year, the company dosed the first healthy subject in the pharmacokinetic study of PrimeC to treat ALS.