NeuroSense Cleared to Study PrimeC Food Interactions in Healthy People

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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NeuroSense Therapeutics will soon begin a Phase 1 clinical trial to investigate the impact of food on PrimeC, a combo medication being developed as a treatment for amyotrophic lateral sclerosis (ALS), in a group of healthy volunteers.

The open-label Phase 1 trial (NCT05232461) is expected to enroll about 12 participants who will receive PrimeC in fasting conditions or after a meal rich in calories and fat. The goal is to determine if taking PrimeC after a meal can influence its availability in the blood.

The announcement comes after the U.S. Food and Drug Administration cleared an investigational new drug (IND) application enabling the company to initiate the pharmacokinetics trial.

According to NeuroSense, the study will generate data that will better inform the design of an upcoming Phase 2b trial in ALS, which is expected to begin in the second quarter of 2022.

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“As we prepare to initiate our Phase IIb study in the next few months, the goal of our pharmacokinetic study under FDA IND is to generate additional data on the bioavailability of PrimeC as it relates to food intake in healthy individuals,” Alon Ben-Noon, CEO of NeuroSense, said in a press release.

“We are deeply committed to improving the lives of people with ALS and are proud to develop a new potential treatment to address this complex disease,” he added.

PrimeC is a combination of two FDA-approved treatments: ciprofloxacin, an antibiotic used to treat bacterial infections, and celecoxib, a prescription non-steroidal and anti-inflammatory medicine for pain and inflammation.

Used together, the medicines target two key features that may cause motor neuron degeneration — inflammation of the nervous system and impaired RNA regulation. Thus, they are expected to slow or prevent ALS disease progression.

PrimeC has been named an orphan drug in the U.S. and Europe, a designation that provides a number of incentives, including assistance with trial protocols and several years of market exclusivity upon approval – seven years in the U.S. and 10 in Europe.

Data from a Phase 2a clinical trial (NCT04165850) showed that PrimeC was safe and well tolerated in adults with ALS, and that it slowed disease progression.

“Data from our Phase IIa clinical study confirmed that PrimeC is a novel therapy with the potential to help people with ALS,” Ben-Noon said.

PrimeC will be given as an extended-release oral tablet (PrimeC-ER) containing a fixed dose of ciprofloxacin and celecoxib (748 mg) formulated so it is released slowly over time.

The upcoming trial in healthy volunteers will compare PrimeC-ER tablets, given with or without food, to a ciprofloxacin tablet given with a celecoxib capsule in fasting conditions.

The study will have three periods, each including an overnight fast of at least 10 hours. In each period, participants will receive a single dose of PrimeC-ER without food, a single dose of PrimeC-ER half an hour after the start of a high-fat, high-calorie breakfast, or a single dose of ciprofloxacin (750 mg) together with a single dose of celecoxib (200 mg) in fasting conditions.

All patients will participate in all three periods in a randomly defined order. Blood samples will be obtained at the beginning of the study and over 48 hours following each dose.

The company recently entered in the third stage of a collaboration with Massachusetts General Hospital in Boston to collect nerve cell-derived exosomes (tiny sac-like structures that form inside cells and get released into the blood) and examine the effects of PrimeC on ALS. Data from this study are expected in the next few months.