MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--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.
"We are pleased to announce first subject dosing as we initiate clinical testing for MDT-637"
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.
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 products that address large unmet market opportunities, and on pulmonary and oral drug 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, COPD and RSV, as well as IBS-C and constipation.
For more information on MicroDose Therapeutx, please visit www.mdtx.com