Pulmatrix has released positive results from initial stage of Phase IB clinical trial of a bronchodilator therapy PUR0200 for patients with chronic obstructive pulmonary disease (COPD).
The company said PUR0200 is the first small molecule product from its novel iSPERSE inhaled dry powder delivery technology, which facilitates flow rate independent, high efficiency drug delivery to the lungs.
The initial part of a 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.
In the initial part of the trial, all doses of PUR0200 were 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.
The company said pharmacokinetic assessments affirmed the effective lung delivery of PUR0200 and the iSPERSE platform and compared favourably to published data on lactose blend formulations.
The data 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 completed in the first quarter of 2014.
The Phase IB trial is being carried out by Quotient Clinical in partnership with Medicines Evaluation Unit professor Dave Singh, while Quotient is also responsible for manufacturing PUR0200 for the trial.
The company is scheduled to complete the clinical trial of PUR0200 in early 2014.
