MAP Pharmaceuticals, Inc, an emerging pharmaceutical company, announced the initiation of a phase IIa clinical trial evaluating MAP0005 for the potential treatment of asthma and chronic obstructive pulmonary disease (COPD).
MAP0005 is a combination of a corticosteroid and a long-acting beta2-agonist delivered to the respiratory tract using MAP Pharmaceuticals' Tempo inhaler. MAP0005 uses the company's proprietary particle technology to combine the corticosteroid and beta-agonist components into a single drug particle in a fixed, pre-specified ratio. In addition, MAP Pharmaceuticals' technology allows for the particle structure to be specifically designed to target relevant areas in the lung and to release drug at a desired rate. MAP Pharmaceuticals believes that this approach may enable the reproducible and consistent administration of the two drugs in an optimal ratio simultaneously, and may provide improved safety and efficacy over currently available combination therapies for asthma and COPD.
"By combining drugs at the micron or submicron particle level, rather than as separate particles, as practiced with current inhaled combination therapies, we can potentially enhance the synergistic effect of the drugs and increase dosing efficiency and consistency," said Thomas A Armer, Ph D, founder and chief scientific officer, MAP Pharmaceuticals. "Furthermore, the novel technology we apply to MAP0005 is potentially applicable to a broad range of combination drug products, for a variety of indications and routes of administration, such as oral administration."
"The initiation of our Phase IIa trial is an important step forward in the continued development of our product pipeline," said Timothy S. Nelson, president and chief executive officer, MAP Pharmaceuticals. "Our pipeline also includes our two late stage product candidates, UDB for the treatment of pediatric asthma and MAP0004 for the treatment of migraine. We plan on initiating phase III clinical programmes for these two product candidates by early 2008".
The phase IIa clinical trial is a randomised, open-label, active-controlled, crossover, safety and dose response study investigating the pharmacokinetics and pharmacodynamics of MAP0005 in approximately 18 adult asthmatic patients. The trial compares two different doses of MAP0005 with one dose of a commercially marketed combination product, all administered by inhalation. The primary endpoints of the trial are the change in forced expiratory volume in one second (FEV1) from baseline, the time to maximum change in FEV1 and the plasma levels for the inhaled corticosteroid.
MAP Pharmaceuticals is developing the Tempo inhaler, a novel pressurized metered dose inhaler that synchronizes the discharge of drug with the patient's breathing cycle, which can be optimised for each therapy based on desired delivery. It is designed to dispense drug in an efficient and consistent manner to minimize dose-to-dose differences in and between patients. The inhaler is convenient and easy to use, and contains a dose counter that can lock out after a maximum number of doses.
Chronic obstructive pulmonary disease refers to several diseases, including chronic bronchitis and emphysema, which cause airflow obstruction and interfere with normal breathing. According to the National Heart Lung and Blood Institute, more than 12 million people in the United States have been diagnosed with COPD and another 12 million likely have the illness but do not know it. COPD is one of the leading causes of death and disability in the United States and is caused in many cases by heavy cigarette smoking in earlier life.
According to Datamonitor, a leading market research company, the potential market for asthma and COPD was estimated at approximately $16 billion in 2005, with expected growth to approximately $30 billion by 2015.
MAP Pharmaceuticals, Inc. uses proprietary inhalation technologies to enhance the therapeutic benefits and commercial attractiveness of proven drugs while minimizing risk by capitalizing on their known safety, efficacy and commercialisation history.