AX-8 / Axalbion - LARVOL DELTA

Axalbion Therapeutics Announces First Patient Dosed in Phase 2 Clinical Study in Chronic Cough with AX-8, a Novel TRPM8 Agonist (Businesswire) - "Axalbion...announced that the first patient has been dosed in the second part of a Phase 2 proof-of-concept, randomized, placebo-controlled clinical study in chronic cough with AX-8, its lead compound. AX-8 is a potent and selective oral agonist of the transient receptor potential melastatin 8 (TRPM8) ion channel. The company has raised additional financing from existing and new investors to support the trial execution and Phase 3 planning....The Phase 2 trial is a randomized, double-blind, placebo-controlled, crossover study evaluating the efficacy and safety of AX-8 in approximately 50 patients with refractory or unexplained chronic cough (RCC/UCC)....The primary efficacy endpoint will be the placebo-adjusted change in cough frequency compared to baseline. The study will take place at multiple centers in the U.K. and is expected to be completed by the second half of 2025."

Financing • Trial status • Chronic Cough

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Axalbion SA | N=50 ➔ 100

Enrollment change • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Axalbion SA | Trial completion date: Jul 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Axalbion SA | Trial completion date: Mar 2023 ➔ Jul 2024 | Trial primary completion date: Dec 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Randomized Proof-of-concept Study of AX-8, a TRPM8 Agonist, in Refractory or Unexplained Chronic Cough (ATS 2023) - "This data suggests TRPM8 agonism shows potential for control of RCC/UCC as an alternative or adjunct to other therapies, especially in those patients complaining of cough driven by throat sensations."

Clinical • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Axalbion Presented 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 (Businesswire) - "Axalbion...presented 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, 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)....Based on these positive findings, the company plans to initiate a Phase 2 study of AX-8 in patients with chronic cough with moderate-to-severe throat discomfort, who are the most likely to benefit from treatment with AX-8."

P2 data • Chronic Cough • Cough

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 (Businesswire) - "Axalbion...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."

P2 data • Chronic Cough • Cough • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Axalbion SA | Trial completion date: Jul 2022 ➔ Mar 2023 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Axalbion Announces Positive Findings from Phase 2 Clinical Study in Chronic Cough with AX-8, a Novel TRPM8 Agonist (Businesswire) - P2 | N=12 | EudraCT number 2017-003108-27 | Sponsor: Axalbion SA | “Results showed: Treatment with AX-8 40 mg BID compared to placebo showed a reduction in cough frequency within the first 15 minutes after treatment and lasting for more than 4 hours. This included a 44% reduction in cough frequency over two hours compared to 18% with placebo and a 35% reduction over 4 hours compared to 20% with placebo. Reduction in cough frequency was seen across patients in the study irrespective of high/low baseline cough frequency, duration of coughing, age or sex. In a pre-determined subset of patients with higher baseline throat discomfort, there was a statistically significant reduction of cough, including a 49% reduction over two hours compared to 8% with placebo and a 32% reduction over 24 hours compared to 13% with placebo...the company plans to initiate a Phase 2 study examining more frequent dosing of AX-8 in the treatment of chronic cough patients in the first quarter of 2023."

New P2 trial • P2 data • Chronic Cough • Cough • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Axalbion SA | Trial completion date: Apr 2022 ➔ Jul 2022

Trial completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Axalbion SA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Pulmonary Disease • Respiratory Diseases

A Study of Efficacy and Safety of AX-8 in Chronic Cough (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: Axalbion SA

Clinical • New P2 trial • Pulmonary Disease • Respiratory Diseases

AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Axalbion SA; Active, not recruiting ➔ Completed; N=10 ➔ 20

Clinical • Enrollment change • Trial completion • F2