Pulmatrix Announces Ph 1b/2a Clinical Trial of Novel iCALM Therapy for Flu
News May 07, 2009
Pulmatrix Inc. has announced it will initiate a randomized, double-blind, placebo-controlled Phase 1b/2a 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.
Pulmatrix is developing 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 inhaled device, offer a novel approach that could fundamentally change the way respiratory diseases; particularly infectious respiratory diseases; are treated, prevented and controlled.
“We believe our iCALM therapies will fundamentally change how we address chronic and infectious respiratory diseases, particularly the flu,” said Robert Connelly, Chief Executive Officer, Pulmatrix. “The extremely encouraging Phase 1 results and preclinical data of PUR003 supports further clinical development, and we are moving aggressively to begin additional efficacy studies later this year.”
The Phase 1 double-blind, placebo-controlled, randomized study was completed in 2008 and designed to evaluate the safety and tolerability of single ascending doses of inhaled PUR003. 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. These results were presented recently at the NIAID Influenza Antiviral Development Workshop.
“As evidenced by recent news, there is clearly a need for new therapies to treat and prevent the transmission of influenza,” said John P. Hanrahan, M.D., M.P.H., Chief Medical Officer and Senior Vice President, Pulmatrix. “Our iCALM therapies have demonstrated a meaningful impact on both the transmission and severity of infectious respiratory diseases in animals, and as such we believe they will offer breakthrough, practical solutions to treat and prevent human infection by airborne pathogens, including influenza.”