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--Last patient dosed in moderate asthma trial and first patient dosed in COPD study--
QUEBEC CITY, Dec. 17, 2013 /PRNewswire/ -- Asmacure Ltee today announced that the company has completed dosing in a Phase 2 trial evaluating its lead compound, ASM-024, in moderate asthma patients, with data anticipated in the first quarter of 2014. The company also has begun patient enrollment in a Phase 2 trial of ASM-024 in patients with moderate and severe chronic obstructive pulmonary disease (COPD). Asmacure Ltee is a clinical-stage biopharmaceutical company focused on the development of novel, proprietary compounds that target cholinergic receptors for the treatment of pulmonary diseases.
"Asthma and COPD represent a significant unmet medical need, as many patients with moderate-to-severe disease are not adequately controlled on existing therapies, even with increasing doses," said Yvon Cormier, M.D., Asmacure's founder and chief medical officer. "With its potentially potent combination of smooth muscle relaxation, muscarinic blocking activity and anti-inflammatory effect, we believe ASM-024 has significant potential as an adjunct to standard of care for chronic maintenance of these two challenging diseases."
The recently completed Phase 2 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 Phase 2 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 the third quarter of 2014.
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.
ASM-024 is under development in a dry powder for inhalation (DPI) dosage form. Typically, DPI's are a preferred dosage form for pulmonary products because they present the potential for delivery of lower, more optimal dosing with greater lung deposition and improved patient tolerability.
More information on these trials is available at www.clinicaltrials.gov.
Asthma is a reversible obstructive lung disease, caused by increased reaction of the airways to various stimuli. It is a chronic inflammatory condition with acute exacerbations. Asthma can be a life-threatening disease if not properly managed. According to the American Lung Association, in 2011 it was estimated that 25.9 million Americans currently have asthma, including 7.1 million children under 18. Of these, 13.2 million Americans (4.1 million children) had an asthma attack. Close to 2.1 million emergency room visits were attributed to asthma in 2009.
Chronic obstructive pulmonary disease (COPD) refers to a group of lung diseases characterized by chronically poor airflow that typically worsens over time, making breathing difficult. The main symptoms of COPD include shortness of breath, cough and sputum production. Emphysema and chronic bronchitis are the two most common conditions that make up COPD. Chronic bronchitis is an inflammation of the lining of the bronchial tubes, which carry air to and from the lungs. Emphysema occurs when the air sacs (alveoli) at the end of the smallest air passages (bronchioles) in the lungs are gradually destroyed. COPD causes serious long-term disability and early death. It is the third leading cause of death in the U.S., affecting more than 12 million Americans.
The company's lead development compound, ASM-024, with its novel mechanism of action, has demonstrated the capabilities of inhibitory effects on inflammation, bronchoprotection and smooth muscle relaxation in pre-clinical asthma models. ASM-024 delivered as a solution for nebulization achieved proof of concept in the treatment of patients with asthma in a phase 2 clinical trial program. The company is now focused on bridging from the ASM-024 solution formulation to the development of the compound in a dry powder for inhalation (DPI) dosage form.
ASM-024 demonstrated a highly-significant effect on FEV1 and methacholine PC20 pre-allergen challenge in a phase 2 study utilizing the solution for nebulization formulation. In pre-clinical asthma models, ASM-024 has demonstrated an adjunctive benefit when combined with long- and short-acting ß-agonists and long- and short-acting muscarinic antagonists.
Based on recent findings about the novel mechanism of action for ASM-024 with nicotinic and muscarinic effects, Asmacure will initiate a phase 2 study in COPD patients in the third quarter of this year.
Asmacure Ltee is a clinical-stage biopharmaceutical company focused on the development of novel, proprietary compounds that target cholinergic receptors for the treatment of inflammation, notably pulmonary airway diseases. The company's lead compound, ASM-024, has a novel mechanism with multi-functional properties at the nicotinic and muscarinic levels. Asmacure was founded by Dr. Yvon Cormier, a noted pulmonologist, and Evelyne Israel-Assayag in 2002 and is based in Quebec City, Quebec, Canada. Asmacure is a privately-held company with the major investors including Domain Associates, Fonds de solidarite des travailleurs du Quebec (F.T.Q.) and Desjardins-Innovatech s.e.c. For more information visit http://www.asmacure.com.
E. Blair Clark-Schoeb
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