The company’s lead development compound, ASM-024, with its novel mechanism of action, has demonstrated the capabilities of anti-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.
The company’s strategy has always been to focus on the development of a dry powder for inhalation (DPI) formulation. The DPI is a preferred dosage form allowing us to deliver lower, more optimal dosing with greater lung deposition. The solution formulation allowed us to move quicker into the clinic and demonstrate a proof of concept. With proof of concept demonstrated in phase 2 with the solution formulation, Asmacure is now progressing into phase 2 in asthma and COPD with a DPI dosage form.
What is the unmet need in COPD?
More than 200 million individuals worldwide suffer from chronic obstructive pulmonary disease (COPD). In the United States alone, COPD affects as many as 15 million people with an estimated additional 15 million undiagnosed. COPD is known to cause 130,000 deaths per year in the U.S. and is now the 3rd leading cause of death. The prevalence of COPD around the world is rapidly expanding and is largely driven by an increase in the number of smokers and environmental pollution. The World Health Organization estimated that 2.7 million people died of COPD worldwide in 2000 and projects total deaths from COPD would increase by more than 30% in the 10 years that followed without interventions to cut risks.
COPD is a chronic disorder that has a number of etiologies but is caused principally by exposure to cigarette smoke and other inhaled pollutants. COPD is characterized by progressive fibro destructive changes of airway and alveolar architecture that leads to limitations in airflow. These pathophysiological changes lead to poorly reversible airway obstruction, airway hyper-reactivity and impairment of alveolar gas exchange. The most common clinical expression of COPD is a combination of chronic bronchitis and emphysema, although in many patients, one or the other predominates. Chronic cough, frequent clearing of the throat, wheezing, and shortness of breath after mild exertion are common symptoms. COPD, commonly is identified in the 5th decade of life, is a slowly progressive, irreversible disease characterized by a gradual loss of lung function. As the disease progresses, the airways become more inflamed resulting in remodeling and alveoli lose their elasticity.
Asmacure’s lead development compound, ASM-024, may one day offer a new therapeutic option to physicians in the treatment of COPD.