Asmacure Reports Positive Phase 1/2a Data For Asthma Drug
Clinical stage biopharmaceutical firm Asmacure announced promising results from the Phase I/IIA of its lead candidate ASM-024 for the treatment of asthma.
ASM-024 has shown capabilities of anti-inflammation, bronchoprotection, and smooth muscle relaxation with its novel mechanism of action in pre-clinical asthma models. Delivered as a solution for nebulization, the drug achieved proof of concept in the treatment of patients with asthma in a phase 2 clinical trial.
The drug is currently being developed in a dry powder for inhalation (DPI) dosage form. DPIs are the preferred dosage form for pulmonary products because they offer potential for delivery of lower, more optimal dosing. This results in greater lung deposition and improved patient tolerability. In the combined Phase I single-ascending dose study and Phase IIA trial investigating ASM-024 in DPI formulation in 15 patients with moderate asthma, the drug showed favorable safety and tolerability profile.
Yvon Cormier, Asmacure's founder and chief medical officer, said, “The data from this trial showed that ASM-024 at therapeutic doses below 20 mg was generally safe and well tolerated and support further exploration of an effect of the ASM-024 DPI alone or as an adjunctive treatment with standard of care in patients with moderate and severe asthma. The pharmacokinetics data from this study provided important information on the potential dose range for ASM-024 in the treatment of the moderate asthma patient when delivered as a dry powder for inhalation."
Martin Driscoll, CEO of Asmacure, said, “Following this study where ASM-024 was studied for the first time in the dry powder for inhalation formulation in humans, these trial data support further development of the ASM-024 DPI in a Phase 2 program with a longer duration of treatment in the moderate and severe asthma population.” Driscoll said that once the trial in moderate to severe COPD is completed this year, the company will plan the next stage of development for ASM-024 DPI.