Press Release – Axalbion to Present Promising Phase 2 Clinical Data in Chronic Cough with AX-8, a Novel TRPM8 Agonist, in an Oral Presentation at the American Thoracic Society (ATS) 2023 International Conference

Proof-of-Concept Study Signals AX-8’s Potential in Chronic Cough Treatment, Especially in Patients with Moderate-to-Severe Throat Discomfort

Manchester, UK and Mountain View, Calif, March 21, 2023 – Axalbion, a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, announced that it will present positive results from a Phase 2 proof-of-concept study with its transient receptor potential melastatin 8 (TRPM8) agonist, AX-8, in patients with refractory or unexplained chronic cough. These data will be presented in an oral session at the American Thoracic Society (ATS) 2023 International Conference, being held in Washington, DC, from May 19 – 24, 2023. (ClinicalTrials.gov NCT04866563; EudraCT Number 2021-000844-23).

Presentation Details:

• Abstract: #7315
• Title: Randomized Proof-of-Concept Study of AX-8, a TRPM8 Agonist, in Refractory or Unexplained Chronic Cough
• Presenter: Dr. Jaclyn Smith, Professor of Respiratory Medicine, University of Manchester, UK, and Principal Investigator
• Session: Clinical Trials in Chronic Lung Disease – Mini Symposia
• Date and Time: Sunday, May 21, 2023, 2:15 pm – 4:15 pm ET

Additional Phase 2 Study Planned in Patients with Chronic Cough
Based on these positive findings, the company plans to initiate a Phase 2 study of AX-8 in chronic cough patients with moderate-to-severe throat discomfort, who are the most likely to benefit from treatment with AX-8.

About TRPM8 and AX-8
TRPM8 is expressed in many of the sensory fibers innervating the upper airways. Axalbion believes that activating TRPM8-expressing fibers with AX-8, a potent TRPM8 agonist, will normalize the upper airway sensitivity in chronic cough patients, decreasing coughing (antitussive effect) and irritation of the throat (counterirritant effect). David Julius and Ardem Patapoutian were awarded the 2021 Nobel Prize in Physiology or Medicine for their discoveries of thermal and mechanical transducers, including the discovery of TRPM8. Since its cloning in 2002, extensive research has identified TRPM8 as a potential target to relieve symptoms or cure several diseases. Animal models have shown that activation of TRPM8-expressing fibers in the skin inhibits sensory hypersensitivity in peripheral neuropathy and inflammation, as well as itching. Additionally, activation of TRPM8 in corneal trigeminal fibers has been shown to increase basal tear secretion and relieve neuropathic ocular pain in patients with dry eye disease.

About Chronic Cough
Chronic cough is defined as a cough lasting for more than eight weeks, often occurring in bouts. More than 80% of patients in tertiary cough clinics have throat irritation which triggers cough bouts, defining a population with oropharyngeal hypersensitivity potentially responding to a topical locally acting drug such as AX-8. After potential triggers such as gastro-intestinal reflux disease (GERD) and asthma have been excluded or treated, cough still remains a significant and common problem for many patients. Chronic cough has a substantial impact on quality of life with, for example, around half of female patients having urinary stress incontinence. There are no approved drugs for the treatment of chronic cough, making it a significant unmet need affecting approximately 26 million people in the U.S. alone, with approximately three million having refractory or unexplained chronic cough lasting for more than a year and approximately six million having refractory or unexplained chronic cough lasting more than eight weeks and less than one year.

About Axalbion
Axalbion is a privately held, clinical-stage biotechnology company developing novel medicines for the treatment of chronic cough. The company, founded in December 2016, is based in Manchester, United Kingdom, a region known for its centers of excellence in respiratory research, with offices in Lausanne, Switzerland and Mountain View, CA. For further information, please visit www.axalbion.com.

Contacts:
Michael Kitt, MD
Chief Executive Officer
Axalbion Therapeutics Limited
investor@axalbion.com
or
Susan Kinkead
Kinkead Communications
susan@kinkeadcomm.com
+1 (415) 509-3610

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