MicroDose Therapeutx has completed the Phase 1 clinical program for its inhaled antiviral fusion inhibitor MDT-637 for the treatment of respiratory syncytial virus infection and plans to present data from the three studies at the upcoming International Respiratory Syncytial Virus Symposium. The company announced completion of the first two studies in April 2012. MDT-637 is a dry powder formulation delivered by a novel dry powder nebulizer.
According to the company, the third study, a double-blind, randomized, 3 period crossover, single ascending dose study with asthma patients, demonstrated that MDT-637 was well tolerated and produced no significant lung function changes or adverse events.
MicroDose Senior Director, Product Commercialization, Robert Cook commented, “We are pleased to announce the successful completion of this study of MDT-637 administration in asthmatic patients. This study provides additional safety data in patients with more sensitive airways to complement the safety and tolerability data previously established in healthy volunteers. With this major milestone behind us, we are now well positioned to advance to our planned Phase 2 efficacy studies.”
Senior VP, Sales & Marketing, Scott Fleming added, “MicroDose supports the well established practice of treating respiratory diseases by delivering the drug directly to the lung and thereby avoiding unnecessarily high systemic concentrations, which is especially important in the infant patient. Our novel dry powder nebulizer makes pulmonary delivery of dry powder medications to infants possible for the first time, in a low cost, handheld device that is intuitive and simple to use by parents or caregivers.”
Read the MicroDose Therapeutx press release.
