Pulmatrix Starts European Pilot Bioequivalence Study of PUR0200 for COPD

Pulmatrix, Inc. (NASDAQ:PULM) reports that enrollment is underway in the Company’s European pilot bioequivalence study of PUR0200, a proprietary iSPERSE™ (Inhaled Small Particles Easily Respirable and Emitted) engineered dry powder formulation of a marketed long acting muscarinic antagonist (LAMA) bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). Enrollment is expected to be completed in the first quarter of 2016 and topline results are expected to be reported in the second quarter of 2016.
According to the press release:

The trial is a seven-period crossover study in 42 healthy volunteers. The trial will evaluate pharmacokinetics (PK) and safety and tolerability of five unique PUR0200 formulations compared to two dosing periods of a marketed reference product. The five unique PUR0200 formulations vary in aerosol properties and strength. PUR0200 is being developed under the PK bioequivalence regulatory pathway for orally inhaled drugs in Europe.

David Hava, Chief Scientific Officer for Pulmatrix commented:

Our goal for the trial is to identify a PUR0200 candidate to advance to a pivotal PK bioequivalence trial in collaboration with our development partner. Upon completion of the trial, we expect to define formulation parameters that will allow us to establish a PK match to the reference product through intelligent formulation design withiSPERSE™. Based on the properties of our iSPERSE™ platform, we believe we will be able to achieve similar distribution of the active pharmaceutical ingredient in the lungs and throughout the body (PK) at a fraction of the dose compared to the reference product.

Click to view the full press release.