MONMOUTH JUNCTION, N.J.–(BUSINESS WIRE)–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.
RSV is a pathogen that infects the human respiratory tract, potentially leading to infections such as bronchiolitis and pneumonia. While most otherwise healthy people recover from the virus within a few weeks, the Centers for Disease Control and Prevention (CDC) estimates that up to 125,000 infants are hospitalized due to RSV infection in the United States each year. There is an increased risk of severe disease in premature infants, the immune-compromised, individuals with chronic obstructive pulmonary disease (COPD) and asthma, and the elderly. Globally, the annual death rate from RSV is estimated at more than 160,000 and the clinical burden of RSV infection is comparable to that of influenza.
About MicroDose Therapeutx, Inc.
MicroDose Therapeutx is a private pharmaceutical company dedicated to improving the quality of life for people suffering from serious diseases. The company focuses on developing proprietary pulmonary and oral products that address large unmet market opportunities, and on dry powder inhalation and combination oral dosage delivery platforms. The company develops its products and technologies independently, as well as in partnership with leading pharmaceutical companies. MicroDose’s current pipeline targets respiratory diseases such as asthma and COPD, respiratory viruses and infections – including RSV – as well as IBS-C and constipation.
For more information please go to: www.mdtx.com
MicroDose Therapeutx, Inc.
Scott Fleming, 732-355-2114
Sr. Vice President, Sales & Marketing