The trial will assess PrimeC’s efficacy, tolerability, and safety for the treatment of amyotrophic lateral sclerosis. Credit: Frank Gaillard.

Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has granted approval for NeuroSense Therapeutics’ clinical trial application (CTA) to enrol participants in the Phase IIb PARADIGM trial of PrimeC to treat amyotrophic lateral sclerosis (ALS).

The prospective, multi-centre, placebo-controlled, multinational, randomised, double-blind Phase IIb trial has been designed for assessing the efficacy, tolerability, and safety of PrimeC in ALS patients.

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More than 50% of the planned 69 study participants have already been enrolled in the trial to date.

In the trial, the participants will be randomised in a 2:1 ratio to receive the study drug or placebo tablets.

All the participants will receive the drug/placebo twice daily (BID), two tablets each time, for six months.

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Those who complete the six month dosing will be switched to a 12-month open-label extension (OLE).

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NeuroSense Therapeutics chief medical officer Dr. Ferenc Tracik said: “We expect to enrol the first study participant in Germany in the next few weeks, and we are very pleased to receive regulatory clearance to enrol and dose people living with ALS, also in Germany, for our PARADIGM study.

“We are currently on track to complete enrolment and report data in the second half of this year.”

The company’s lead drug candidate, PrimeC is a new, extended-release oral formulation that is composed of a fixed-dose combination of ciprofloxacin and celecoxib.

It has been designed for synergistically targeting many important ALS mechanisms, which contribute to iron accumulation, impaired RNA regulation, inflammation, and motor neuron degeneration, for potentially inhibiting disease progression.