PUR0200, a new dry powder formulation being developed for the treatment of chronic obstructive pulmonary disease (COPD), has shown positive pharmacokinetic results in a Phase 1 pilot study. The results were announced by Pulmatrix, which led the study in collaboration with Mylan, under the terms of an agreement.
Although it incorporates a marketed long-acting bronchodilator, a muscarinic antagonist, PUR0200 is formulated to use Pulmatrix’s iSPERSE dry powder delivery technology. Typically, the bronchodilator is delivered orally, which limits its effectiveness because only a small percentage of the drug actually reaches the lungs. Using the iSPERSE technology, PUR0200 can be directly administered to the lungs, potentially achieving the same effect as the marketed product at 20 percent of the currently administered dose.
“We are pleased with the pharmacokinetic profile of PUR0200 emerging from the pilot bioavailability study,” David L. Hava, PhD, chief scientific officer of Pulmatrix, said 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 a previous Phase 1b trial, the company demonstrated that PUR0200 is beneficial in moderate-to-severe COPD patients, improving their lung function, with similar exposure to the reference product but at lower doses.
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.”
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