Research & Development
NeuroSense Therapeutics wins ODD for ALS drug PrimeC and announces two clinical studies in ALS
10 February 2020 -

Drug company NeuroSense Therapeutics reported on Friday the launch of two clinical studies in the US and in Israel to evaluate the safety, tolerability and efficacy of PrimeC in slowing down the disease progression as well as improving quality of life in ALS (Amyotrophic Lateral Sclerosis) patients.

ALS, known as Lou Gehrig's disease, is a neurodegenerative disease, characterized by the degeneration of motor neurons, leading to progressive paralysis of all voluntarily innervated muscles and affecting mobility, balance, communication, swallowing and breathing.

The company added that a Phase IIa study is being conducted in Israel at Tel-Aviv Sourasky Medical Center (TASMC), by Prof. Vivian Drory.

Another similar Phase IIa study is being conducted by the company in the USA at two sites: BNI (The Barrow Neurological Institute) in Phoenix Arizona, by Prof Jeremy Shefner and Columbia University in NYC by Dr Jinsy Andrews. The studies plan to enroll 45 patients.

According to the company, the PrimeC targets two fundamental mechanisms underlying the pathogenesis of ALS. The two clinical studies were initiated following exceptional results PrimeC achieved in pre-clinical models of ALS. The analysis of motor neurons, neuromuscular junctions and aspects of the immune system in the ALS treated fish, indicated that PrimeC is neuroprotective.

In addition, the company received an orphan drug designation from the FDA for the use of PrimeC to treat ALS, including seven years of market exclusivity in the US.

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