Clinical-stage biopharmaceutical company Asmacure has new results from its Phase 1/2a clinical trial evaluating its lead product in moderate asthma patients. Results show ASM-024, a novel compound that targets cholinergic receptors, was safe, well-tolerated, and effective.
“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,” said Yvon Cormier, MD, founder of Asmacure’s founder and chief medical officer, in a press release. “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.”
Phase 1 of the study delivered single-ascending dose to 40 healthy participants, with 32 receiving ASM-024 and 8 receiving placebo. Doses ranged from 1-60 micrograms. Phase 2 delved into the pharmacokinetics of ASM-024 in 15 patients with moderate asthma. Patients inhaled dry powder in doses ranging from 1-30 micrograms, and they visited the Investigator Clinical Site for each treatment, spaced seven days apart.
Patients experienced no serious adverse events during the trials, and ASM-024 was generally well-tolerated and safe for patients when delivered in doses less than 20 micrograms.
“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,” said Martin Driscoll, chief executive officer. “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.”
The current formulation is dry powder for inhalation, which most clinicians and patients prefer, as it can deliver lower, more optimal dosing with greater lung deposition and fewer adverse effects. Specifically, ASM-024 inhibits inflammation and has a bronchoprotective effect. When it was in a nebulized form, ASM-024 demonstrated great effects on forced expiratory volume in one second during Phase 2 clinical trials.