MicroDose completes third and final MDT-637 Phase 1 study on RSV infection

MicroDose Therapeutx, Inc., announced today the completion of its third and final Phase 1 clinical study for MDT-637 with its novel inhaled antiviral fusion inhibitor, MDT-637, for the treatment of RSV infection. MicroDose will present the data from all three clinical studies at the 8th Annual International Respiratory Syncytial Virus Symposium taking place from Sept. 27-30 in Santa Fe, NM. Successful completion of the previous two Phase 1 studies (Study MDT-637-CP-101 and MDT-637-CP-102) was announced on April 24, 2012.    

MicroDose has completed a double-blind, randomized, 3 period crossover, single ascending dose study to assess the safety, and tolerability of inhaled MDT-637 in subjects with clinically confirmed intermittent, or mild-to-moderate persistent, asthma. The study (Study MDT-637-CP-103) assessed the pharmacokinetics, safety and tolerability of MDT-637 after repeat doses of inhaled MDT-637 from MicroDose's novel dry powder nebulizer technology.

MDT-637 was well tolerated in asthmatic subjects with no significant clinical adverse events and no clinically significant changes in lung function at all dose levels tested. Cohorts of patients that received MDT-637 reported no treatment-related trends in clinical laboratory results, vital signs, ECG results, or physical examination finding.

"We are pleased to announce the successful completion of this study of MDT-637 administration in asthmatic patients," said Robert Cook, Ph.D., Senior Director, Product Commercialization at MicroDose, "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."

Added Scott Fleming, Sr. Vice President, Sales & Marketing, "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."

MDT-637 is a fusion inhibitor that has been shown to block RSV infection in preclinical testing. The product is formulated for inhaled delivery via MicroDose's proprietary dry powder nebulizer, a novel device which allows for the rapid delivery of dry powder medications via tidal inhalation to the site of infection in the respiratory tract.    

Source: MicroDose Therapeutx, Inc.