Lexington, Massachusetts-based Pulmatrix Inc. is enrolling participants for a European pilot bioequivalence study on its product PUR0200, a bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD). The company expects to finish enrollment by the first quarter of 2016 and report initial results in the second quarter.
Pulmatrix says its iSPERSE (inhaled small particles easily respirable and emitted) technology offers an improvement over other inhaled technologies because the particles are engineered to be small, dense, and easily dispersed once inhaled, resulting in improved drug delivery to the airways. One of the advantages of iSPERSE, the company says, is that it is independent of lung function, providing a reliable dose delivery no matter the patient’s health status. The company’s other proprietary products include PUR1900, for patients with cystic fibrosis (CF), and PUR1500, for the treatment of idiopathic pulmonary fibrosis (IPF).
The Phase 1 clinical trial (NCT02671825), titled “A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects,” is designed as a seven-period crossover study in 42 healthy volunteers. The main objective is to evaluate the pharmacokinetics (PK), safety, and tolerability of five different PUR0200 formulations, varying in aerosol properties and strength, and compare the results with data of two dosing periods of the marketed reference drug.
PUR0200, a branded generic dry powder formulation of a long-acting muscarinic antagonist (LAMA) bronchodilator, is being developed under the PK bioequivalence regulatory pathway for orally inhaled drugs in Europe.
“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,” David Hava, chief scientific officer of Pulmatrix, said in a press release. “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 with iSPERSE. 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.”