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April 12, 2022

NeuroSense initiates subject dosing in PK study of ALS asset

The study will assess the impact of food on PrimeC’s bioavailability in healthy adult subjects.

NeuroSense Therapeutics has enrolled and dosed the first healthy subject in the pharmacokinetic (PK) study of its combination drug candidate, PrimeC, to treat amyotrophic lateral sclerosis (ALS).

PrimeC comprises a fixed-dose mixture of ciprofloxacin and celecoxib, which are approved by the US Food and Drug Administration (FDA).

It can potentially act on various crucial ALS mechanisms that lead to motor neuron degeneration, inflammation, iron build-up and impaired regulation of ribonucleic acid (RNA) to hinder disease progression.

The PK randomised, open-label, single-dose, three-treatment, three-period crossover study is designed to assess the impact of food on PrimeC’s bioavailability versus the bioavailability of co-administered ciprofloxacin tablets and celecoxib capsules.

It will be carried out in 12 healthy adults in the US, as per the investigational new drug (IND) protocol cleared by the FDA.

Clinical Trials Arena reported on 5 April early design details of the company’s forthcoming Phase IIb trial of the same ALS drug.

NeuroSense CEO Alon Ben-Noon said: “We expect to complete and report data on this pharmacokinetic study in Q3 2022. 

“The combined data from both the PK 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. 

Earlier, PrimeC obtained Orphan Drug status from the FDA and the European Medicines Agency (EMA). 

A concluded Phase IIa clinical trial of PrimeC had met the safety and efficacy endpoints including lowering of functional and respiratory deterioration and statistically significant variations in ALS-associated biological markers which demonstrated the biological activity of the therapy. 

NeuroSense intends to commence a placebo-controlled, double-blind multinational Phase IIb trial of an optimised dose and an upgraded formulation in the second quarter of this year.

In March this year, the company announced plans to start a Phase I PK study of PrimeC for ALS in healthy adults.

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