FDA Clears the Way for NeuroSense's PrimeC Candidate for ALS

Jana Shea/Shutterstock 

A U.S. Food and Drug Administration Investigational New Drug (IND) application has been approved for NeuroSense Therapeutics’s PrimeC, a potential therapeutic targeting amyotrophic lateral sclerosis (ALS). The drug candidate uses a unique combination-drug formulation to inhibit mechanisms that contribute to the neurodegenerative effects associated with ALS.

In addition to the IND application approval, the FDA has granted PrimeC an Orphan Drug Designation. Both components of PrimeC’s composition are familiar in the pharmaceutical industry. Ciprofloxacin is a trusted antibiotic, while celecoxib is FDA-approved as a nonsteroidal anti-inflammatory drug. As an extended-release, fixed-dose capsule, patients would benefit from fewer doses and less complicated regimens. Safety has been demonstrated in Phase IIa trials of the drug, with Phase IIb to be initiated following the conclusion of a pharmacokinetic study. 

NeuroSense CEO Alon Ben-Noon described how PrimeC fills a gap in the pharmaceutical industry. “PrimeC is a novel therapy with the potential to help people with ALS and address a $3 billion market in need of a more effective treatment,” Ben-Noon said.

This market valuation reflects the financial responsibility held by patients with ALS as well as the responsibility placed on the U.S. healthcare system. The rate of affected patients is expected to increase in upcoming decades, in both the U.S. and Europe. Ben-Noon explained, “We are deeply committed to improving the lives of people with ALS and are proud to develop a new potential treatment to address this complex disease."  

The IND application permits a Phase I pharmacokinetic investigation into the safety, and subsequent efficacy of PrimeC. The pharmacokinetic study (NCT05232461) will evaluate how the drug moves through a patient’s body during treatment, as it relates to food intake. PrimeC will need to demonstrate safety and bioavailability mechanisms within an ALS-diagnosed patient’s body before moving further down the clinical trial pipeline. The trial is not yet recruiting but estimates a total enrollment of 12 participants.  

With a treatment for ALS, NeuroSense hopes to combat the debilitating symptoms associated with neurodegeneration, such as muscular atrophy, motor neuron degeneration and eventual muscle paralysis. These symptoms can affect communication, breathing, or mobility. Often, patients with ALS do not survive 10 years post-diagnosis, and no cure has been found. 

PrimeC has also been granted Orphan Drug Designation by the European Medicines Agency (EMA), which mirrors the FDA program and entices researchers to investigate treatments for rare diseases in exchange for incentives, such as a decade of market exclusivity before generics are considered. 

NeuroSense is based out of Cambridge, Massachusetts, and has centered its mission statement upon finding options for patients with severe neurodegenerative disorders. In collaboration with the Massachusetts General Hospital of Boston, this mission will be furthered in 2022 by evaluating the link between neuron-derived exomes, ALS biological markers and changes induced when a patient is treated with PrimeC.  

Phase IIb for PrimeC will begin in the second half of 2022 as a double-blind, placebo-controlled study. The future pipeline for NeuroSense includes the development of other treatments for neurodegenerative diseases, such as StabiliC, which has indications for Parkinson’s Disease and CogniC, indicated for Alzheimer’s disease.