Pulmatrix recently reported topline results from a Phase 1 pilot study evaluating PUR0200, an iSPERSE dry powder formulation incorporating a marketed long-acting and once daily bronchodilator, as a therapy for chronic obstructive pulmonary disease (COPD).
Under collaborative terms and with support from the pharmaceutical company Mylan, Pulmatrix headed the pharmacokinetic (how it works in the body) bioavailability trial. Mylan will have certain, limited rights to PUR0200 after a successful completion of the study.
“We are pleased with the pharmacokinetic profile of PUR0200 emerging from the pilot bioavailability study,” said David L. Hava, PhD, chief scientific officer of Pulmatrix, in a press release. “Together with our collaborator, we developed a robust trial design aimed at testing several hypotheses critical to establishing bioequivalence. We believe that the data from the current study has satisfied this goal and informs our continued development of PUR0200 for European Registration, seeking to demonstrate therapeutic equivalence to the reference product.”
In the pilot trial, 42 patients were randomly assigned to treatment with a single dose of one of the five formulations of PUR0200, or they received the reference drug. The clinical trial assessed the safety, how the therapy works in the body, tolerability of PUR0200, and its comparative bioequivelence to the other product.
The results showed that PUR0200 kinetics were identical across all formulations and across all evaluated doses. The results also revealed that there were dose comparative increases in exposure for comparably sized formulations. The relationships between formulation parameters and bioavailability were also defined. Plasma pharmacokinetic measures were similar between the reference drug and selected PUR0200 formulations.
Because nearly all of the dose reaches the site of action in the lung, and is not swallowed or otherwise lost, PUR0200 can achieve the same effect as the marketed product at 20% of the dose administered.
The safety profile of PUR0200 was similar to the reference product, and there were no adverse events reported.
Robert Clarke, PhD, CEO of Pulmatrix, said: “On the basis of the current data, we look forward to advancing PUR0200 through further clinical development. As the most advanced program in our pipeline, the completion of this PUR0200 study is an important milestone for the company. With PUR0200 and our iSPERSE-based proprietary pipeline, we are committed to meeting unmet patient needs in respiratory disease.”
Pulmatrix has earlier reported positive data from a Phase 1b study of PUR0200 in patients with moderate-to-severe COPD. In that study, treatment with PUR0200 resulted in lung function improvements with similar exposure as the reference product, but at lower doses. Results from the pilot trial will be presented at a future scientific meeting.