Source: Annual Congress 2010 - New treatments for asthma and COPD
Disease area: Airway diseases

Abstract

Background: ASM-024 is a small synthetic agonist of the nicotinic acetylcholine receptor that displays both anti-inflammatory and myorelaxant properties and reduces hyperresponsiveness in various in vitro or in vivo preclinical models, including human tissue and cells. ASM-024 has been designed not to cross the blood-brain barrier. It is currently under early clinical testing stage in Canada.
Objectives: To assess the safety, tolerability and pharmacokinetic profile of ASM-024 following inhalation in healthy humans subjects.
Methods: Fifty-four male and 11 female volunteers (age: 18-50 years) received ASM-024 or a placebo by nebulisation, either as single administration of target doses of 3 to 600 mg, or repeatedly at target doses of 100 or 200 mg b.i.d. for five consecutive days.
Results: No clinically significant safety findings were observed with regard to vital signs, ECGs, clinical laboratory evaluations or spirometry. The most frequent adverse events (AEs) included intermittent coughing, effects on the throat (e.g., irritation, secretions) and taste. The incidence but not the severity of these AEs increased with dose and repeat administration. Other AEs were mild, isolated and not dose or time related. Systemic exposure to ASM-024 was observed in all subjects, with dose-related increases in both plasma and urine.
Conclusion: ASM-024 can be safely administered by inhalation in humans and could potentially have local as well as systemic activity. These data warrant further clinical development of ASM-024 for the treatment of asthma.

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Citations should be made in the following way:
L. Vachon, P. Furci, Y. Cormier (Quebec City, Canada). A phase I inhalation study on ASM-024, a novel nicotinic agonist being developed for the treatment of asthma. Eur Respir J 2010; 36: Suppl. 54, 1175

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