Axalbion Announces Positive Results from a Phase 2 Clinical Study in Chronic Cough with AX-8, a Novel TRPM8 Agonist

Axalbion Announces Positive Results from a Phase 2 Clinical Study in Chronic Cough with AX-8, a Nove ...

In patients with chronic cough, AX-8 reduces cough frequency and improves patient-reported outcomes.

MANCHESTER, England, and MOUNTAIN VIEW, Calif. (BUSINESS WIRE)June 29, 2022

Axalbion, a clinical-stage biopharmaceutical company focusing on developing novel medicines to treat cough, has announced good results from a Phase 2 proof-of-concept study (AX8-003) with its transient receptor potential melastatin 8 (TRPM8) agonist, AX-8, in patients with persistent or unexplained chronic cough.

AX-8 was evaluated in 51 patients with refractory or unexplained chronic cough. Patients received 40 mg of the medication twice daily, eight hours apart, or a matching placebo for two weeks, followed by a seven-day washout period before switching over to the other treatment for two weeks.

Michael Kitt, MD, chief executive officer, and we are pleased to report Phase 2 data showing that AX-8 decreased cough frequency in patients with chronic cough in the immediate post-treatment period, as well as improved key patient and clinician-reported outcomes.

Results have been presented:

AX-8 is an ideal candidate for the treatment of cough because of its rapid onset of action. Patients have cough bouts interrupted with periods of quiet with reduced or no coughing, according to principal investigator Jacky Smith, MD, professor of respiratory medicine at the University of Manchester, UK.

In the first quarter of 2023, the company intends to conduct a Phase 2 study that will investigate more frequent dosages of AX-8 in the treatment of chronic cough patients.

Axalbion claims that activating TRPM8-expressing fibers with AX-8 will improve nasal respiration in chronic cough patients, reducing coughing (antitussive effect) and throat irritation (counterirritant effect). In a previous open-label trial in 12 patients with refractory/unexplained chronic cough, AX-8 appeared to reduce cough when given as a single 5 mg ODT (EudraCT Number 2017-003108-27).

David Julius, PhD, and Ardem Patapoutian, PhD, were awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of thermal and mechanical transducers, including TRPM8. TRPM8 has been identified as a potential treatment for many illnesses since its cloning in 2002; many animal models have demonstrated that activation of TRPM8 has been shown to improve basal tear secretion and alleviate neuropathic ocular pain in patients with dry eye disease.

Chronic cough is defined as a cough that lasts longer than eight weeks, often occurring in bouts. Generally, cough is a significant unmet need affecting more than 26 million people in the United States alone, with approximatively three million having refractory or unexplained chronic cough lasting longer than eight weeks and under one year.

Axalbion is a privately held, clinical-stage biotechnology business that is developing novel medicines for millions of individuals who suffer from chronic cough and dry eye. Its facilities are located in Manchester, the United Kingdom, known for its top respiratory research facilities in Lausanne, Switzerland, and Mountain View, CA.

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