US-based clinical stage biotechnology firm Pulmatrix has reported positive results from initial stage of Phase IB clinical trial of its lead candidate PUR0200, a bronchodilator therapy, for patients with chronic obstructive pulmonary disease (COPD).
PUR0200 is a small molecule product that leverages the company’s novel iSPERSE inhaled dry powder delivery technology, which facilitates flow rate independent, high efficiency drug delivery to the lungs.
The first part of the two-stage Phase IB trial assessed the safety, tolerability and the pharmacokinetic/pharmacodynamic and pulmonary function after administration of four single ascending doses of PUR0200 in 24 patients with moderate COPD.
During the first stage of the trial, all doses of PUR0200 were seen to be well tolerated and were associated with increases in lung function, as measured by peak and trough forced expiratory volume (FEV1) from baseline compared to placebo dosing.
Pulmatrix said pharmacokinetic assessments affirmed the effective lung delivery of PUR0200 and the iSPERSE platform and compared favourably to published data on lactose blend formulations.
Data secured from the first part of the Phase IB clinical trial will be used to inform dose selection for the second part of the trial, which is expected to be complete in the first quarter of 2014.
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The second part of the trial, a cross-over design study, includes an active comparator arm and is likely to start shortly.
Pulmatrix chief scientific officer David Hava said the data from the first part of the company’s PUR0200 clinical trial marked a major milestone for its lead iSPERSE drug candidate.
"This clinical evidence validates that iSPERSE offers exceptional lung delivery advantages relative to existing products," Hava said.
"This data significantly advances our platform and provide impetus for continued development of PUR0200 and other products in our pipeline."
Quotient Clinical in partnership with Medicines Evaluation Unit professor Dave Singh is carrying out the Phase IB trial, and is also manufacturing the required PUR0200 for the trial.
Pulmatrix chief executive officer Robert Clarke said: "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."
The company expects to complete the clinical trial of PUR0200 in 2014 and present the results from both the parts at a future scientific meeting.
Image: A chest X-ray demonstrating severe COPD. Photo: courtesy of Jmh649.