Respira reports results of DPI drug engine clinical study against COPD, asthma

Respira Therapeutics, a product development company focused on inhaled therapeutics to improve patients' lives, today announced the results of a clinical feasibility study of the Company's drug engine technology (DET). The results of the study highlight significant advantages of Respira's dry powder inhaler (DPI) innovations for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

A seminal advancement over current state-of-the-art DPI, the Company's patented DPI drug engine delivers inhaled medications to the diseased lung at three to four times the rate of existing inhalers without the prerequisite formulations or lactose drug carriers.

Clinical Feasibility

The primary objective of the crossover study was the safety and proof-of-concept of Respira Therapeutics' novel mechanism of action, as evidenced by drug concentration levels in blood post-inhalation. Subjects inhaled the study medication via Respira's DET or a DPI standard on days 1 or 8, respectively, and peak drug levels were measured from blood samples 1 hr post-inhalation. Inhalation via Respira's DET resulted in ca. 1.5 to 2-fold greater drug levels than those measured after pulmonary delivery from the HandiHaler DPI. No adverse events were reported in the study.

Dr. Jacques Pappo, Respira's President of Discovery and Clinical Development, said, "We have encouraging data of our unique approach to inhaled therapeutics for respiratory disease. Pure drug hybridized to Respira's DET, in the absence of added excipients or formulations, showed highly efficient delivery to the lungs. We are very pleased to have demonstrated Respira's enabling capability for the transplant rejection market and to have successfully achieved the primary endpoint of our collaboration."

Dr. Robert S. Langer, Respira Therapeutics' Scientific Advisory Board member and renowned Institute Professor at the Massachusetts Institute of Technology, commented, "Respira Therapeutics has achieved an important milestone with its promising data in humans."

The results from the proof-of-concept study in humans were achieved fully six months ahead of schedule.

Multiple Market Applications for Respira Therapeutics Technology

Respira's widely applicable technology allows the company to pursue multiple opportunities in multi-billion dollar markets. The global respiratory product market represents a $52 billion opportunity, with a compounded annual growth rate of 9.3%.

The Company's formulation-free approach has proved enabling for a particle engineered drug for the transplant rejection market. Of the total transplant market valued at $4.8 billion in 2006, immunosuppressive drug regimens used in the management of lung transplantation totaled $200 million (4%). This market is expected to increase to $252 million by 2012.