Research & Development
NeuroSense Therapeutics' PrimeC Investigational New Drug application receives US FDA approval
16 November 2022 -

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), an Israel-based company developing treatments for severe neurodegenerative diseases, announced on Tuesday that it has received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) to enrol patients in the United States for its phase 2b PARADIGM study of its lead drug candidate PrimeC to treat amyotrophic lateral sclerosis (ALS).

The company is currently enrolling patients in Israel and is likely to open clinical sites for patient recruitment in the European Union in the coming weeks. The company has received Orphan Drug Designation with the FDA and the European Medicines Agency (EMA).

The study is intended to synergistically target various key ALS mechanisms that contribute to motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation to potentially inhibit the progression of ALS. It is a Phase 2b double-blind, placebo-controlled, multinational clinical trial that intends to evaluate the efficacy, safety and tolerability, in people living with ALS. It is enrolling and randomising 69 people living with ALS in a 2:1 ratio to receive PrimeC or placebo, respectively. Participants who complete the six-month double-blind, placebo-controlled dosing period will be converted to the PrimeC active arm for a 12-month open label extension.

NeuroSense expects to enrol and dose the first US patients in the next few weeks at leading ALS centres on both the east and west coast.

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