Asmacure Advances Lead Lung Compound

Asmacure has completed dosing in a Phase II trial evaluating its lead compound, ASM-024, in moderate asthma patients, with data anticipated in 1Q14. The company also has begun patient enrollment in a Phase II trial of ASM-024 in patients with moderate and severe chronic obstructive pulmonary disease (COPD).

The recently completed asthma trial is a randomized, double-blind, placebo-controlled study with a primary outcome designed to evaluate the safety, tolerability, and dose selection of the ASM-024 dry powder for inhalation (DPI) dosage form in 15 patients with moderate asthma. The COPD trial is a randomized, double-blind, placebo-controlled, two-way crossover study designed to evaluate clinical outcomes and safety of the ASM-024 DPI dosage form in approximately 15 patients with GOLD 2 and GOLD 3 COPD. Each patient will be dosed for two weeks in each treatment period of the two-way crossover design. Data from this trial are expected in 3Q14.

ASM-024’s novel multi-functional mechanism of action involves effects at the nicotinic and muscarinic levels. Previous studies have shown that ASM-024 solution formulation induced smooth muscle relaxation as well as anti-inflammatory and bronchodilating effects, which may address an unmet medical need as an adjunctive treatment with current standard of care in patients with moderate to severe asthma and COPD. The precise mechanisms of action of ASM-024 continue to be studied.