Pulmatrix to initiate Phase Ib/IIa trial of flu drug

Pulmatrix has reported that it will initiate a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical trial of its novel inhaled therapy, PUR003, to demonstrate its effectiveness, safety and tolerability in an experimental influenza challenge study. The study will begin in the third quarter of 2009.

The Phase I double-blind, placebo-controlled, randomized study designed to evaluate the safety and tolerability of single ascending doses of inhaled PUR003 was completed in 2008. The drug was found to be well tolerated at all doses evaluated with no serious adverse events reported.

Furthermore, in preclinical studies, PUR003 produced significant treatment efficacy and demonstrated prophylaxis in multiple models of influenza, across different strains and in different animal species, including swine, said Pulmatrix.

The company noted that it is developing novel, inhaled Cationic Airway Lining Modulator (iCALM) drugs, which stimulate host defense mechanisms within the airway to treat and prevent infection, independent of pathogen. These dual mechanism therapies, delivered via an easy-to-use inhaled device, offer a truly novel approach that could fundamentally change the way respiratory diseases – particularly infectious respiratory diseases – are treated, prevented and controlled, the company claimed.

Robert Connelly, CEO of Pulmatrix, said: We believe our iCALM therapies will fundamentally change how we address chronic and infectious respiratory diseases, particularly the flu. The extremely encouraging Phase I results and preclinical data of PUR003 supports further clinical development, and we are moving aggressively to begin additional efficacy studies later this year.