Pulmatrix has announced topline results from the Phase 1 bioavailability trial of Pulmatrix’s PUR0200 generic tiotropium DPI initiated in January 2016 and completed in May 2016. The company had previously announced positive Phase 1b results for a trial of PUR0200 in COPD patients.
The 7-way crossover study involved 42 healthy subjects who each received a dose of one of 5 PUR0200 formulations or the reference product. According to the company, “The target PUR0200 therapeutically equivalent dose is significantly lower than the reference product.”
Pulmatrix Chief Scientific Officer David L. Hava said, “We are pleased with the pharmacokinetic profile of PUR0200 emerging from the pilot bioavailability study. 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.”
CEO Robert Clarke commented, “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 is partnered with Mylan on development of PUR0200 for the treatment of COPD, and Mylan has an option for non-US marketing rights.
Read the Pulmatrix press release.
