PrimeC PARADIGM trial drops U.S. sites, adds Canada, Germany
NeuroSense to meet with FDA about Phase 3 trial if Phase 2b is successful
The Phase 2b trial testing PrimeC in people with amyotrophic lateral sclerosis (ALS) will no longer enroll patients in the U.S., its maker NeuroSense Therapeutics has announced.
Meanwhile, the company has been given the green light from regulatory agencies in Germany and Canada to enroll new participants, joining earlier approvals in Israel and Italy.
The PARADIGM Phase 2b trial (NCT05357950), which began enrolling last June, seeks to recruit about 69 adults with ALS, ages 18-75. It’s currently about 50% enrolled, with top-line data expected in the second half of the year.
“In the interest of treating and completing dosing of people living with ALS in an expedient and safe manner through PARADIGM, we’ve focused our North American recruitment in Canada,” said Alon Ben-Noon, NeuroSense CEO, in a company press release.
NeuroSense intends to meet with the U.S. Food and Drug Administration (FDA) about a pivotal Phase 3 trial that would include U.S. sites should PARADIGM conclude successfully.
The decision to drop U.S. sites was agreed upon by NeuroSense and the FDA after the agency requested additional nonclinical data to support the trial’s duration.
The request was made because PrimeC is intended as a long-term treatment. The PARADIGM trial currently involves a six-month placebo-controlled part followed by an open-label extension wherein all patients will receive PrimeC for an additional year.
“We expect to enroll the first study participant in Germany in the next few weeks, and we are very pleased to receive regulatory clearance to enroll and dose people living with ALS also in Germany for our PARADIGM study,” Ferenc Tracik, MD, NeuroSense’s chief medical officer, said in a separate press release.
Participants in PARADIGM are being randomly assigned to receive PrimeC as two extended-release oral tablets twice daily — 1,496 mg a day — or a placebo for six months in addition to standard therapies.
The study’s main goals are safety and the impact of PrimeC on disease biomarkers. Secondary goals include measures of disease severity, lung function, quality of life, and survival.
Although PARADIGM won’t include U.S. sites, NeuroSense still intends for a future trial to take place in the U.S., which would support a potential regulatory application for PrimeC’s U.S. approval if it’s successful.
“We look forward to working with the FDA on a path that includes clinical sites in the U.S. in a future Phase 3 pivotal study of PrimeC to address the dire unmet need of the U.S. ALS community who are eager to receive PrimeC for long-term use,” Ben-Noon said.
PrimeC is made up of a fixed dose combination of the antibiotic ciproflaxin and celecoxib, an anti-inflammatory medication, both of which are individually approved by the FDA and with established safety profiles.
It’s thought the combination may target key ALS disease processes, including reducing inflammation, improving RNA processing, and normalizing iron accumulation. Its original formulation showed promise on disease progression in a previous Phase 2 trial (NCT04165850).
PrimeC holds orphan drug status in the U.S. and Europe, a designation given to accelerate the development of potentially life-saving treatments for rare diseases.