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MicroDose Therapeutx Announces Conclusion of MDT-637 Phase I Single and Multiple Ascending Dose Studies in Healthy Volunteers for Treatment of Respiratory Syncytial Virus (RSV)

MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Apr 24, 2012 - MicroDose Therapeutx, Inc. announced today that it has concluded the second of two Phase I studies with its novel inhaled antiviral fusion inhibitor, MDT-637, for the treatment of RSV infection.

MicroDose has completed two double-blind, randomized, placebo-controlled dose-ranging studies in healthy volunteers assessing the pharmacokinetics, safety and tolerability of MDT-637 after single (Study MDT-637-CP-101) and multiple ascending doses (Study MDT-637-CP-102) of inhaled MDT-637 from MicroDose's novel dry powder nebulizer technology.

MDT-637 was well tolerated with no significant clinical adverse events and no clinically significant changes in lung function at all dose levels tested. Cohorts of volunteers received MDT-637 up to a maximum dose level daily for 10 days, with no treatment-related trends in clinical laboratory results, vital signs, ECG results, or physical examination findings.

From a pharmacokinetic perspective, MDT-637 achieved levels in the respiratory tract that were several orders of magnitude higher than concentrations necessary to inhibit clinical isolates of RSV in vitro, whereas plasma levels of MDT-637 were markedly low. Therefore, this new study data shows successful delivery of antiviral directly to a site of RSV infection, without reaching unnecessarily high systemic concentrations.

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

“We are pleased to announce the successful completion of these studies for MDT-637,” said Robert Cook, Ph.D., Senior Director, Product Commercialization Group, at MicroDose, “these studies provide important safety and pharmacokinetic data that will assist us in preparations for Phase 2 clinical trials anticipated to start in 2012.”

MicroDose is developing MDT-637 in collaboration with Gilead Sciences, Inc., under an agreement announced April 20, 2011. As previously reported, MicroDose is responsible for the development of MDT-637 through Phase IIa clinical trials.

About RSV

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

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.

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Contact: MicroDose Therapeutx:
Scott Fleming, 732-355-2114


Posted: April 2012