Gilead and MicroDose Therapeutx announce license and collaboration agreement to develop MDT-637

Gilead Sciences, Inc. (Nasdaq: GILD) and MicroDose Therapeutx, Inc. today announced that the companies have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV).

Under the terms of the agreement, Gilead will pay MicroDose an upfront payment and provide research funding to support MicroDose’s continued development of MDT-637 through Phase IIa clinical trials. Gilead can assume full responsibility for clinical development following Phase IIa. MicroDose also could receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as development fees and royalties on future potential net sales.

MDT-637 is a fusion inhibitor that has been shown to block RSV infection in preclinical testing. The product is formulated for pulmonary delivery via MicroDose’s proprietary dry powder inhaler, which allows for rapid delivery to the site of infection (in the respiratory tract). MicroDose plans to file the Investigational New Drug (IND) reactivation with the U.S. Food and Drug Administration (FDA) and to initiate a Phase I study this year with MDT-637.

“This strategic collaboration is a significant milestone in MicroDose’s vision to develop first-in-class therapies for major unmet medical needs,” said Anand Gumaste, President and CEO of MicroDose. “Given Gilead’s scientific and clinical expertise in virology, this partnership provides a strong validation of the potential for MDT-637 to become an important therapeutic advance for those affected by RSV infection.”

“There is an urgent need to improve upon RSV treatment and care,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We believe this program aligns well with our expertise in both antiviral and respiratory drug development and we look forward to working with the MicroDose team to advance MDT-637 into clinical testing.”

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.