MicroDose initiates MDT-637 Phase 1 trial in respiratory syncytial virus

MicroDose Therapeutx, Inc. today announced that the first human subject has been dosed in a Phase 1 clinical trial of MDT-637, MicroDose's inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV). This Phase 1 trial follows the reactivation of the United States IND for MDT-637 as re-formulated for delivery using MicroDose's proprietary dry powder nebulizer.

The Phase 1 clinical trial is a U.S.-based, single ascending dose, randomized, placebo controlled trial studying the safety, tolerability and pharmacokinetics of MDT-637 in 48 healthy adult subjects.

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 first subject dosing as we initiate clinical testing for MDT-637," said Robert Cook, Ph.D., Senior Director, Product Commercialization Group, at MicroDose. "This study will provide important safety and pharmacokinetic data for assisting dose selection in subsequent clinical development."

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.