PrimeC is safe and well-tolerated for the treatment of amyotrophic lateral sclerosis (ALS) and shows potential to slow disease progression and lung function decline, according to interim results from a Phase 2a clinical trial.
Given these results, developer NeuroSense Therapeutics will continue investigating PrimeC with additional analysis of the ongoing trial, and is planning to launch another clinical study in early 2021.
“We are very encouraged by the interim results and are now preparing for more analyses that may reveal additional layers of observations,” Alon Ben-Noon, CEO of NeuroSense, said in a press release. “We intend to initiate an additional clinical trial by the beginning of 2021 with the new PrimeC advanced formulation.”
PrimeC is a combination treatment that includes two existing medications, ciprofloxacin and celecoxib, to treat ALS. Ciprofloxacin is an antibiotic medication that is typically prescribed for bacterial infection, and celecoxib is a prescription non-steroidal anti-inflammatory agent, similar to aspirin and ibuprofen.
Together, the two medications aim to treat two major symptoms of ALS: inflammation of the nervous system and impaired regulation of RNA activity.
The PrimeC formulation was first investigated in preclinical studies using zebrafish with ALS-causing mutations. In those studies, the fish given PrimeC were able to regain swimming abilities to a greater degree than had been seen in studies using the same model.
Following the successful preclinical studies, NeuroSense launched two clinical trials to investigate PrimeC in humans, including the Phase 2a trial (NCT04165850) that showed encouraging interim results.
The trial, called NST002, enrolled 15 patients at the Tel-Aviv Sourasky Medical Center, in Israel, to investigate the safety, tolerability, and efficacy of PrimeC as a treatment for ALS.
In the study, each patient is required to take one 303 mg capsule of PrimeC, three times per day, for a trial period of 15 months.
Safety and tolerability are being evaluated through the occurrence of adverse events or the decision to stop treatment during the study.
Efficacy of the treatment is being investigated using the ALS Functional Rating Scale – Revised, an established questionnaire that assigns a score based on the severity of ALS symptoms, and vital capacity, an indicator of lung function.
The interim results showed that PrimeC was safe and well-tolerated in the 15 patients, and that it slowed disease progression and lung function decline in the last three months of the six-month study, though these benefits did not reach statistical significance.
The NST002 trial is scheduled to run for another six months, allowing NeuroSense to further investigate the PrimeC treatment in the enrolled patients.
“These clinical signals, in conjunction with the very promising preclinical results in multiple ALS models, clearly warrant further investigation in a larger, placebo-controlled study,” said Jeremy Shefner, MD, PhD, chair of neurology at the Barrow Neurological Institute in Phoenix, AZ, and an advisor to the NeuroSense program.
The additional clinical study, a Phase 1 trial (NCT04090684) taking place in the U.S., has enrolled 30 ALS patients and is designed similarly, though patients will be taking two capsules of PrimeC per day (instead of three).
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