QUEBEC CITY, Canada, April 15, 2013 /PRNewswire/ -- Asmacure Ltee, a clinical-stage biopharmaceutical company focused on the development of novel, proprietary compounds that target cholinergic receptors for the treatment of pulmonary diseases, announced the start of a phase 1/2 clinical trial of its lead compound, ASM-024, in a dry powder for inhalation (DPI) formulation. The company's lead product, ASM-024, has a novel multi-functional mechanism of action with nicotinic and muscarinic effects and has demonstrated anti-inflammatory effects, bronchoprotection and smooth muscle relaxation in pre-clinical asthma models.
Asmacure dosed volunteers in the first clinical trial with ASM-024 in the dry powder for inhalation (DPI) formulation which was developed to deliver the compound with a more optimal dose and greater lung deposition. This clinical trial has a single-ascending dose and repeat administration phases and bridges to a phase 2 study in moderate asthmatics. The study is being conducted in Quebec City, Quebec, Canada with Dr. Louis-Philippe Boulet as the principal investigator for the phase 2 portion in the moderate asthma population.
"With its anti-inflammatory, bronchoprotection and smooth muscle relaxation effects shown in pre-clinical asthma models and the results from our phase 2 program with our solution formulation, ASM-024 shows potential as a new treatment option for individuals with asthma," said Yvon Cormier, MD, founder and chief medical officer. "The novel mechanism of action could prove beneficial for patients with moderate to severe asthma and COPD where the dual nicotinic and muscarinic effects could provide added benefit."
"We are pleased to be bridging from our ASM-024 solution clinical program into clinical studies with our preferred DPI formulation in moderate asthma patients," said Martin Driscoll, chief executive officer. "With the growing need for adjunctive treatments in the effort to better control moderate to severe asthma, we are hopeful the novel mechanism of ASM-024 will provide clinicians and patients with a new adjunctive option. We also look forward to the progression of the ASM-024 DPI into a phase 2 COPD trial later this summer."
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.
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. Typically, DPI's are a preferred dosage form for pulmonary products by allowing for delivery of lower, more optimal dosing with greater lung deposition.
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 beta-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 www.asmacure.com.
E. Blair Schoeb
SOURCE Asmacure Ltee