NeuroSense Therapeutics Receives Orphan Drug Designation for Amyotrophic Lateral Sclerosis (ALS) Drug

NeuroSense Therapeutics, a Biotech organization is promoting PrimeC, a combination medicine which aims to slow or halt ALS progression, published today the initiation of two clinical education to evaluate the advantage of PrimeC for people living with ALS. A Phase IIa research is being transferred in Israel at Tel-Aviv Sourasky Medical Center (TASMC), by Prof. Vivian Drory. A similar investigation is being done 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 education plan to enroll 45 patients, 15 at each site. In addition to security and tolerability, the company will assess the drug’s effectiveness and ability to slow disease progression and to enhance the quality of life.

Pre-Clinical Studies

Prime targets two fundamental mechanisms carrying the pathogenesis of ALS. The two clinical education was initiated following outstanding results PrimeC performed in pre-clinical models of ALS. In these investigations, taken on two different zebra-fish models, each with a separate ALS-causing mutation, the transgenic fish were handled either with PrimeC or left untreated. The diving abilities of the PrimeC managed ALS fish increased drastically related to the controls and significantly more than with any other union previously tested in these models.

Besides, the analysis of motor neurons, neuromuscular joints, and aspects of the immune system in the ALS treated fish indicated that PrimeC is neuroprotective.

“PrimeQ, produced by NeuroSense, was shown to be very prosperous in pre-clinical studies, and we are glad to be examining it in our clinic now, hopeful to see how it will change the cases,” stated Prof. Vivian Drory, ALS expert from TASMC.

“Sufferers are inspired to participate in the trial, and the recruitment rate is very high.” Jeremy Shefner, Chair of Neurology at the Barrow Neurological Institute, said: “PrimeC has interesting pre-clinical data and we require a good safety profile. It is satisfying to be able to offer this novel experimental treatment to the sufferers.”

Alon Ben-Noon, CEO of NeuroSense Therapeutics, continued: “The potential PrimeC inspires us holds to help ALS patients. We are happy to be evaluating it in these sufferers, providing them hope while testing the drug’s efficacy.

The special relationship the company has with patients and their families contributes to the way we progress in our development, and we are thankful for this opportunity. We believe and expect to see positive interim issues within some months.

True to our mission statement, NeuroSense has taken upon itself to quickly advance analysis and development towards a useful treatment in the ALS field.”

neuroscience has recently received an orphan drug designation from the FDA for the use of PrimeC to treat ALS. The appointment grants PrimeC seven years of market exclusivity in the US.

ALS

ALS, also known as Lou Gehrig’s disease, is a neurodegenerative illness characterized by the degeneration of motor neurons, leading to progressive paralysis of all voluntarily innervated muscles, consequently affecting mobility, balance, communication, swallowing, and breathing. Death typically occurs 2-4 years after diagnosis, usually due to respiratory failure. There are about 30,000 ALS patients in the US, with 6,000 new cases diagnosed every year.