Pulmatrix has announced the completion of a Phase 1 pharmacokinetic study of its PUR0200 generic tiotropium DPI in healthy volunteers. Pulmatrix announced the initiation of the study in February 2016.
The company has partnered with Mylan on development of PUR0200, which it says is “is focused on demonstrating bioequivalence between PUR0200 and a currently marketed product” in Europe. Data from a Phase 1b study of PUR0200 in moderate-to-severe COPD patients was announced in May 2014.
Pulmatrix Chief Scientific Officer David Hava commented, “The completed study should significantly expand on our understanding of PUR0200 and the reference product pharmacokinetics. We expect to share top line results of the study in the near future. Our progress in completing subject recruitment and all clinical procedures is a significant achievement for Pulmatrix staying on time and budget with our publicly disclosed development plans for PUR0200.”
Read the Pulmatrix press release.
