An announcement via PR NewsWire by NeuroSense Therapeutics based in Cambridge, Massachusetts carried the results of its multi-dose study of PrimeC to treat amyotrophic lateral sclerosis (ALS)
Expectations are that these data from Phase 1a, (NCT05436678) together with the new Phase IIb PARADIGM trial, will be of assistance in the design of a Phase III PrimeC crossover trial that hopes to meet FDA requirements.
Note that many clinical trials are parallel trials whereby the enrollees receive the same treatments. Other trials, such as the anticipated Phase III Prime C trial, are called crossover trials where the participants receive several treatments mostly by a sequence of two or more exposures.
PrimeC combines two FDA-approved drugs, ciprofloxacin and celecoxib, into an extended-release formulation releasing these components simultaneously.
According to Ferenc Tracik M.D., CMO of NeuroSense, the results of the additional study show an improved PrimeC profile as well as confirm its safety.
About the Phase 1a Trial
The multiple-dose clinical compared PrimeC to co-administered ciprofloxacin and celecoxib under the FDA’s Investigational New Drug Program. In each segment of Phase 1a, twenty participants received either co-administered celecoxib and ciprofloxacin or two PrimeC tablets every twelve hours, six and one-half days for thirteen administrations.
About the Study Results
NeuroSense has completed its Phase IIa study meeting the study’s goals of efficacy and safety. This included reducing respiratory and functional deterioration. Significant changes also occurred in ALS-associated biological markers, an indication of the biological activity of PrimeC. It is now being investigated in the PARADIGM Phase IIb trial to treat patients with ALS.
PARADIGM is Now Recruiting for the Phase IIb Trial
Results involving the bioavailability of PrimeC found that a coordinated release of celecoxib and ciprofloxacin supports the PrimeC dosing process now being used in the PARADIGM study, Phase IIb.
Sixty-nine patients are currently being enrolled in Phase IIb of NeuroSense’s PARADIGM trial in an effort to assess the efficacy, tolerability, and safety of PrimeC in ALS patients. The dosing ratio is 2:1 with patients randomly receiving PrimeC or a placebo.
Study endpoints involve assessing ALS biomarkers and clinical efficacy, improvement of quality of life, tolerability, and safety. Data should be available by mid-2023.
Additional findings confirm that safety data for the referenced drugs may be relied upon in a 505(b)(2) application. The 505(b)(2) New Drug Application process confirms the appropriateness of relying on available safety data for each of the aforementioned drugs.
PrimeC, a combination therapy to treat ALS, received the U.S. FDA’s Orphan Drug Designation. This award grants market exclusivity together with potential regulatory and tax benefits from the date of the drug’s approval. Prime C also received an Orphan designation from the EMA.
About Amyotrophic Lateral Sclerosis (ALS)
ALS is incurable. The disease causes total paralysis and is fatal within two to five years of diagnosis. Five thousand patients in the United States will receive an ALS diagnosis each year. ALS comes with an annual burden of $1 billion annually. The U.S. and EU growth rate is anticipated to be twenty-four percent by the year 2040.
About the Company
NeuroSense is a biotechnology company that specializes in treating patients with debilitating neurodegenerative disorders. The company considers Parkinson’s, ALS, Alzheimer’s disorders, and other neurodegenerative diseases to be associated with significant unmet needs. NeuroSense is developing therapies that target multiple pathways relating to these diseases.