Pulmatrix Inc., a clinical stage biopharma dedicated to the development of inhaled therapies to address serious pulmonary diseases, recently announced that its European pilot bioequivalence study on PUR0200 for the treatment of chronic obstructive pulmonary disease (COPD) is now open for enrollment. This stage is expected to be completed in the first quarter of 2016, with topline results predicted in the second quarter of the year.
PUR0200 is the company’s proprietary iSPERSE™ (Inhaled Small Particles Easily Respirable and Emitted) engineered dry powder formulation of a marketed LAMA (long acting muscarinic antagonist) bronchodilator. iSPERSE technology has the potential to solve considerable limitations of other inhaled technologies currently available, like nebulizers, conventional lactose blend dry powder inhalers, or metered dose inhalers.
iSPERSE particles are designed to easily disperse when inhaled, delivering the drugs more efficiently to the lungs and airways. This targeted delivery also helps to reduce systemic exposure and side effects, since iSPERSE is also flow-rate independent, which should provide a reliable dosage across patients despite the status of their lung function.
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.
For more information about the clinical trial and how to participate, please visit this link.