Pulmatrix today announced the successful completion and positive results of the first part of a two-part Phase IB clinical study in chronic obstructive pulmonary disease (COPD) patients with their lead clinical candidate PUR0200. PUR0200 is a bronchodilator therapy for COPD and is the first small molecule product from the company's novel iSPERSE™ inhaled dry powder technology. The first part of the Phase 1B clinical trial evaluated the safety, tolerability and the pharmacokinetic/pharmacodynamic profile of single ascending doses of PUR0200 in patients with moderate COPD.
The first part of the Phase 1B study evaluated pharmacokinetics and pulmonary function after administration of four single ascending doses of PUR0200 in 24 patients with moderate COPD. All doses of PUR0200 were generally well tolerated and were associated with increases in lung function, as measured by peak and trough forced expiratory volume (FEV1) from baseline, and compared to placebo dosing. Pharmacokinetic assessments affirmed the effective lung delivery of PUR0200 and the iSPERSE platform and compared favorably to published data on lactose blend formulations. The data from the first part of the study will be used to inform dose selection for the second part of the study, a cross-over design study that starts this month and includes an active comparator arm. The study is targeted for completion in Q1 2014 and data from both parts of the study will be presented at a future scientific meeting.
David Hava, PhD, Chief Scientific Officer of Pulmatrix, commented, "The data from the first part of our PUR0200 clinical trial mark a significant milestone for our lead iSPERSE drug candidate. This clinical evidence validates that iSPERSE offers exceptional lung delivery advantages relative to existing products. These data significantly advance our platform and provide impetus for continued development of PUR0200 and other products in our pipeline."
The Phase 1B study is being conducted by Quotient Clinical in Nottingham, England, in conjunction with Professor Dave Singh at the Medicines Evaluation Unit in Manchester, England and PUR0200 is being manufactured by Quotient Clinical for the study.
Robert Clarke, PhD, Chief Executive Officer of Pulmatrix added, "These study results with PUR0200 represent an important step in establishing a next generation approach for creating easily inhaled, easy-to-use therapeutics with the iSPERSE technology. We are encouraged by the continued robust performance of PUR0200 in COPD patients and look forward to completion of the clinical trial in early 2014."
PUR0200 was designed using the Pulmatrix proprietary iSPERSE particle engineering platform, an engineered particle technology that facilitates flow rate independent, high efficiency drug delivery to the lungs. The PUR0200 bronchodilator therapy is designed to provide improved performance over current therapeutics on the market.
Researchers identify key molecular alterations from endurance exercise that could combat chronic diseases