PrimeC, potential ALS therapy, earns patents in Europe, Japan, Israel
Results of Phase 2b study due by year's end, Phase 3 ALS clinical trial planned
NeuroSense Therapeutics has received key patents in Europe, Japan, and Israel covering the use of PrimeC, its investigational, fixed-dose combination therapy, in treating neurological diseases such as amyotrophic lateral sclerosis (ALS).
These patents are valid through 2038 and join others covering Prime C’s use in the U.S., Canada, and Australia. Additional patents relating to PrimeC are pending.
PrimeC is being tested in a Phase 2b clinical trial, called PARADIGM (NCT05357950), which enrolled 69 adults with ALS at sites in Israel, Italy, and Canada. The company expects to present top-line trial data in the coming months.
Should results be promising, a pivotal and global Phase 3 clinical trial in ALS patients is planned for 2024.
PrimeC showed safety and potential efficacy in earlier ALS clinical trial
“We are pleased to receive this most recent patent grant in Europe, Japan, and Israel which adds to our growing [intellectual property] estate as we expect the clinical read-out from our PARADIGM Phase 2b study towards year’s end,” Alon Ben-Noon, NeuroSense’s CEO and co-founder, said in a press release.
“ALS remains a pressing unmet need, and our unwavering commitment to advancing our program, supported by robust intellectual property, underscores our dedication to delivering an effective therapy for individuals battling ALS,” Ben-Noon added.
The company also was given Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA) and opened an office in Germany, NeuroSense reported in a separate press release. The designation offers multiple benefits, including regulatory guidance throughout clinical development, financial benefits, and facility inspections, as well as fee exemption in the first years should the therapy be approved.
PrimeC is an oral, fixed-dose combination of ciprofloxacin, an antibiotic, and celecoxib, an anti-inflammatory medication. The two compounds have well-established safety profiles and are approved in the U.S.
Used together, these medicines may have the potential to prevent disease progression by targeting key mechanisms that contribute to the degeneration of motor neurons, the nerve cells affected in ALS. Specifically, PrimeC is designed to reduce inflammation and iron accumulation, and to improve RNA processing.
In a previous Phase 2a clinical trial (NCT04165850) in Israel, an initial formulation of PrimeC taken three times daily was found to be safe and well tolerated in ALS patients. It also was seen to slow declines in the ability to perform daily activities and in lung function compared with an historical group of patients.
Phase 2b clinical trial of PrimeC to be followed by open-label extension
A new, extended-release formulation of PrimeC then was developed to be longer acting, requiring twice daily dosing. That formulation is being tested in the PARADIGM trial, with Prime C or a placebo given patients twice a day for six months.
Participants, ages 18 to 75 and whose symptoms of muscle weakness started less than 2.5 years before enrollment, also are continuing on their standard ALS medications.
The trial’s main goals are to evaluate PrimeC’s safety and tolerability, as well as changes in ALS biomarkers. Secondary goals will investigate the treatment’s efficacy on motor abilities, lung health, quality of life, and survival.
After completing the trial, patients can join an open-label extension phase, where all will be treated for up to one year.
PrimeC was designated an orphan drug in the U.S. and the European Union. This status is given to therapies that aim to treat rare diseases and provides several benefits, including exemption from regulatory fees, assistance with clinical trial protocols, and several years of market exclusivity upon approval.