Dry powder for inhalation formula reported safe, well tolerated in treating patients with asthma

Asmacure announced that combined phase 1 and 2a study results of a novel mechanism of action in a dry powder for inhalation formulation displayed safety and tolerability in treating healthy volunteers and patients with moderate asthma.

“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 [dry powder for inhalation] alone or as an adjunctive treatment with standard of care in patients with moderate of severe asthma,” Yvon Cormier, MD, founder and chief medical officer of Asmacure, said in a press release. “The pharmacokinetics data from the study provided important information on the potential dose range for ASM-024 in the treatment of the moderate asthma patient when delivered as a [DPI].”

The phase 1 study included 40 healthy volunteers; 32 received ASM-024 DPI single-ascending doses ranging from 1 mg to 60 mg, and eight received placebo. In the phase 2a study, 15 patients with moderate asthma received ASM-024 DPI in doses ranging from 1 mg to 30 mg.

“Each patient received a placebo and up to two ascending doses of the ASM-024 DPI on each visit to the [investigator] site,” in the phase 2a study, according to the release.

No serious adverse events were reported during the trials; common adverse events were cough and taste, the release 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,” Martin Driscoll, Asmacure chief executive officer, said in the release.