Asmacure has announced that a Phase 1/2a trial of ASM-024 inhalation powder found that the drug was safe and well tolerated. In April 2013, the company announced that it had dosed the first patient in the study.
The Phase 1 portion of the trial was a single ascending dose study in 40 healthy subjects; the Phase 2a portion of the trial involved 15 asthma patients with moderate disease. Doses in the Phase 1 study ranged from 1 mg-60 mg, the company said, with doses in the Phase 2a study from 1-30 mg.
Asmacure Founder and Chief Medical Officer Yvon Cormier 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.”
CEO Martin Driscoll added, “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. We will determine our next steps for the development of the ASM-024 DPI once we conclude our trial later this year in moderate to severe COPD where we have dosed patients up to two weeks.”
Read the Asmacure press release.
