Pulmatrix Inc has announced that its European pilot study on PUR0200 for the treatment of COPD is open for enrollment.
The clinical trial, “A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects,” is a seven-period crossover study that aims to recruit 42 healthy volunteers. The trial will assess pharmacokinetics (PK), tolerability and safety of five single PUR0200 formulations that vary in aerosol properties and strength, in comparison to two dosing periods of an already-marketed reference product
“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,” Pulmonatrix CSO David Hava 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 at a fraction of the dose compared to the reference product.”
PUR0200 is being developed under the PK bioequivalence regulatory pathway for orally inhaled drugs in Europe.