Subjects with refractory or unexplained chronic cough will be part of the trial. Credit: Doucefleur/Shutterstock.

Axalbion Therapeutics has dosed the first subject in the second part of a Phase II clinical trial for its leading compound, AX-8, targeting chronic cough.

The company has secured additional funding from existing and new investors to support the trial’s progression and to facilitate planning for the Phase III trial.

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Following promising initial results, part two of the study has been initiated, focusing on patients with chronic cough and moderate-to-severe throat discomfort.

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

Participants will be given AX-8 40mg or a matching placebo three times a day at intervals of four hours over two weeks.

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This will be followed by a seven-day washout period before switching to the opposite treatment for another two weeks.

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The placebo-adjusted change in cough frequency compared to baseline is the trial’s primary efficacy endpoint.

Axalbion plans to conduct the study at multiple centres across the UK.

This study is anticipated to be completed by the second half of last year.

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

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

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