Pulmatrix, Inc. (NASDAQ: PULM), today announced positive topline data from a Phase 1 pilot pharmacokinetic bioavailability trial of PUR0200. PUR0200 is a novel dry powder formulation of a currently marketed once daily bronchodilator, formulated in the company's proprietary iSPERSETM dry powder delivery technology.
Under the terms of an agreement with Mylan, Pulmatrix led the pilot pharmacokinetic clinical study and supportive development work with collaborative support from Mylan. Mylan has retained an option for PUR0200 ex-U.S. rights based on successful completion of the clinical study. Financial terms of the agreement are confidential.
The clinical trial results support the continued development of PUR0200 as a potential therapeutic equivalent of the marketed long acting muscarinic antagonist for the maintenance of bronchospasm in patients with chronic obstructive pulmonary disease (COPD) in Europe. The target PUR0200 therapeutically equivalent dose is significantly lower than the reference product. PUR0200 was safe and well tolerated in 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. "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 bioavailability study, 42 subjects were randomized to receive a single dose of one of five PUR0200 formulations or the reference product in a 7-period crossover design to assess the pharmacokinetics, safety and tolerability of PUR0200 and its relative bioavailability to the reference product. The completed study aimed at defining the relationship of PUR0200 formulation characteristics to the pharmacokinetic profile of the drug to establish formulation parameters for further development towards formal pharmacokinetic bioequivalence based on peak plasma concentrations (Cmax) and plasma concentrations over time (Area under the curve; AUC).
Clinical highlights from the study include:
- Pharmacokinetics. PUR0200 kinetics were similar across all doses and formulations tested, with dose proportional increases in exposure for similarly sized formulations and the relationships between formulation parameters and bioavailabilty were defined. Plasma pharmacokinetic measures were comparable between selected PUR0200 formulations and the reference product.
- Safety and tolerability. There were no serious adverse events and the safety profile of PUR0200 was comparable to that of the reference product. Of the 42 enrolled subjects, 41 completed all dosing periods.
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.
The company previously reported positive results from a Phase 1b clinical trial of PUR0200 in moderate-to-severe COPD patients. In the Phase 1b trial, PUR0200 improved lung function (FEV1) and resulted in similar exposure as the reference product, but at markedly lower doses. Data from the pilot bioequivalence study will be presented at a future scientific conference.