Dosing Begins in Phase 1 Trial of PrimeC, Combo Therapy for ALS

Lindsey Shapiro, PhD avatar

by Lindsey Shapiro, PhD |

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A first healthy volunteer has been enrolled in a Phase 1 trial and given a first dose of PrimeC, an investigational combination therapy for people with amyotrophic lateral sclerosis (ALS), the treatment’s developer, NeuroSense Therapeutics, announced.

The open-label Phase 1 trial (NCT05232461) is a pharmacokinetic study, or one that evaluates how a treatment moves into, through, and out of the body. The trial aims to enroll 12 healthy adults in the U.S. to establish the effects of food on PrimeC’s bioavailability, or the amount of medication in blood circulation and able to have a therapeutic effect.

Results will inform a multinational Phase 2b trial, which the company plans to launch by late June, that will incorporate an upgraded formulation and an optimized dose of PrimeC.

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“The combined data from both the [pharmacokinetic] study and our upcoming Phase IIb study will assist in designing a pivotal Phase III trial of PrimeC for the treatment of ALS in alignment with FDA requirements,” Alon Ben-Noon, NeuroSense’s CEO, said in a press release.

Data from the pharmacokinetic study in healthy adults is expected in the third quarter of this year, Ben-Noon added. NeuroSense received clearance from the U.S. Food and Drug Administration (FDA) to open the trial in March.

PrimeC is a fixed-dose oral therapy that combines two FDA-approved medications, ciprofloxacin and celecoxib. Ciprofloxacin is an antibiotic used to treat bacterial infections, while celecoxib is a nonsteroidal anti-inflammatory medicine used for pain and swelling.

This combination targets two key mechanisms that underlie motor nerve degeneration in ALS: inflammation and impaired RNA regulation. Of note, RNA is the molecule that serves as the template for the production of proteins in cells.

In doing so, PrimeC is expected to slow ALS progression. The treatment has been designated an orphan drug in the U.S. and Europe, a status that gives financial incentives for advancement to its developer.

Data from a previous Phase 2a trial (NCT04165850) in Israel showed the therapy was safe, well-tolerated, and able to slow disease progression in 15 adults with ALS.

In the ongoing Phase 1 trial, PrimeC will be administered as an extended-release tablet (PrimeC-ER) to slowly release the therapy into the bloodstream.

The trial consists of three parts, each involving a different combination of medication and food. Each participant will complete all three parts in a random order.

Prior to each part, participants will fast overnight for at least 10 hours. After that, they will receive one of the following combinations: a single dose of PrimeC-ER (748 mg) without food; that same dose 30 minutes after the start of a high-fat, high-calorie breakfast; or a single dose of ciprofloxacin (750 mg) and a single dose of celecoxib (200 mg) without food.

Blood samples will be collected before and across 48 hours (two days) after each dose to evaluate the treatment’s bioavailability. A one-week washout period will separate each part of the study, and participants will need to return for a follow-up visit one week after their last dosing.

Contact information for those interested in taking part in this Phase 1 study is here.

NeuroSense is also collaborating with Massachusetts General Hospital to study the effects of PrimeC in the brain by collecting and examining nerve-cell derived exosomes — small sac-like structures that contain certain molecules and form inside cells before being released into the bloodstream. Findings are expected in the coming months.