A clinical study shows positive pharmacokinetic results in a phase 1 pilot study for PUR0200, a new dry powder formulation being developed for the treatment of COPD.
In the Phase 1 pilot study, the researchers enrolled 42 participants, who were randomized to receive the reference product or a single dose of one of five PUR0200 formulations, in a seven-period crossover design. PUR0200 pharmacokinetics, bioavailability, tolerability, and safety were evaluated and compared to the reference product.
Results revealed that all doses and formulations of PUR0200 had similar kinetics, with bigger formulations correlating with proportional increases in exposure. Also, the plasma measures were similar across the reference product and the selected PUR0200 formulations.
PUR0200 safety profile was also similar to that of the reference product, with none of the patients exhibiting serious adverse events.
“On the basis of the current data, we look forward to advancing PUR0200 through further clinical development,” said Robert Clarke, PhD, CEO of Pulmatrix. “As the most advanced program in our pipeline, the completion of this PUR0200 study is an important milestone for the company … [and in] meeting unmet patient needs in respiratory disease.”