Axalbion administers a dose to first volunteer in trial to treat chronic cough

The study involves subjects with persistent or unexplained chronic cough. Image credit: Doucefleur/Shutterstock.

Axalbion Therapeutics has administered a dose to the first subject in the second part of a Phase II clinical trial of its lead compound AX-8 for the treatment of chronic cough.

The Company has secured additional funding from existing and new investors to support the study progress and facilitate Phase III trial planning.

Following promising initial results, the second part of the study was initiated, focusing on patients with chronic cough and moderate to severe throat discomfort.

This proof-of-concept, randomized, double-blind, placebo-controlled, crossover Phase II study is designed to evaluate the efficacy and safety of AX-8 in approximately 50 patients with refractory or unexplained chronic cough (RCC/UCC).

Participants will receive 40 mg of AX-8 or a corresponding placebo three times daily at four-hour intervals for two weeks.

This is followed by a seven-day washout phase before switching to the other treatment for a further two weeks.

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The primary efficacy endpoint of the study is the placebo-corrected change in cough frequency from baseline.

Axalbion plans to conduct the study in several centres across the UK.

This study is expected to be completed in the second half of last year.

AX-8, an orally disintegrating tablet placed on the tongue, acts as a potent and selective agonist of the transient receptor potential melastatin 8 (TRPM8) ion channel.

Michael Kitt, CEO of Axalbion Therapeutics, said: “We are pleased to announce that Axalbion has initiated the second part of its Phase II clinical trial of AX-8 for the treatment of chronic cough, a disease with significant unmet need.

“In the first part of this study, AX-8 showed promising results with a significant and sustained reduction in cough frequency, particularly in patients with severe throat discomfort, a distressing symptom observed in most patients with chronic cough.”