PARADIGM Trial for PrimeC Set to Enroll Soon in US, Italy
PrimeC is NeuroSense Therapeutics' experimental ALS therapy
NeuroSense Therapeutics has received the go-ahead to begin enrolling patients in the U.S. and Italy for a Phase 2b clinical trial testing PrimeC, the company’s experimental therapy for amyotrophic lateral sclerosis (ALS).
The clinical trial, called PARADIGM (NCT05357950), enrolled its first participant in June. The study is expected to recruit about 69 adults with ALS, ages 18 to 75; enrollment is currently underway at a single site in Israel.
With clearance from both the U.S. Food and Drug Administration (FDA) and the Italian Medicines Agency (AIFA), the company said it is expecting to open trial sites in the U.S. — on both the east and west coasts — and in Italy in the next few weeks.
“FDA’s acceptance of our [investigational new drug request] paves the way for NeuroSense to commence patient enrollment in the U.S. and is another significant milestone achieved in our drug development plan,” Alon Ben-Noon, CEO of NeuroSense, said in a company press release.
“Clearance from AIFA, Italy’s health regulatory agency, is another important milestone achieved that supports our goal of providing patients in need from the [European Union], in addition to the US and other regions, the opportunity to join the PARADIGM study and receive PrimeC,” Ben-Noon said one day later in another press release.
PrimeC contains a fixed-dose combination of the antibiotic ciprofloxacin and the anti-inflammatory medication celecoxib. Each of these medicines is separately approved by the FDA for non-ALS indications; according to NeuroSense both have well-established safety profiles.
This combination may have beneficial effects in ALS through multiple mechanisms, such as reducing inflammation, improving RNA processing, and normalizing iron accumulation. Results from a prior open-label Phase 2a trial (NCT04165850), which tested PrimeC in 15 ALS patients, indicated the therapy may slow disease progression.
In the Phase 2b PARADIGM study, researchers will investigate a new extended-release version of PrimeC that’s expected to maximize the benefits of the combination therapy. In the trial, two-thirds of participants will be treated with PrimeC — two tablets twice daily, for a total daily dose of 1,496 mg — or given a placebo, for six months. Participants will be allowed to continue on their standard therapies during the trial.
“This clinical trial is evaluating our new and improved extended release formulation of PrimeC, which may provide a better outcome than already observed in our prior Phase 2a study,” Ben-Noon said.
The study’s main goals are to evaluate safety and assess the impact of treatment on disease biomarkers. The effect on measures of ALS severity also will be assessed as secondary goals. Top-line results are expected by mid-2023.
“We are pleased to offer PrimeC to patients who are eager to take part in the clinical program, and we look forward to completing enrollment and announcing results in the next several months,” Ben-Noon said.
Patients who complete the six-month placebo-controlled portion of the PARADIGM study will have the option to continue into an open-label extension trial, where all participants will be given PrimeC and monitored for another year.
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