Pulmatrix has announced that a pilot bioequivalence study of 5 formulations of its PUR0200 DPI for the treatment of COPD has begun enrollment. The company is partnered with Mylan on development of the DPI.
According to Pulmatrix, enrollment of 42 healthy volunteers for the study should be completed by the end of the first quarter of 2016, and results should be available the following quarter. The 5 PUR0200 formulations “vary in aerosol properties and strength,” the company said.
Pulmatrix Chief Scientific Officer David Hava 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 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.”
Read the Pulmatrix press release.
