Dosing underway in mid-stage study of Theravance drug for COVID-19

The first UK patient has been dosed in a 159-subject Phase 2 clinical trial evaluating Theravance Biopharma’s (NASDAQ:TBPH) Janus kinase inhibitor TD-0903 in hospitalized COVID-19 patients with acute lung injury (ALI).

The study consists of two parts. The first will assess the safety, tolerability and clinical response of ascending doses of TD-0903 over a seven-day period in patients showing hypoxia (lack of oxygen in the blood). The second part, to be conducted in the UK, other European countries and the U.S., will randomize patients to receive one of three doses of TD-0903 or placebo over a seven-day period.

The primary endpoints of Part 2 will be the change in SaO2/FiO2 ratio (metric of respiratory dysfunction) from baseline at day 7 and ventilator-free days from baseline to day 28.

The company says TD-0903 has the potential to inhibit cytokine storm (out-of-control immune response) associated with ALI and prevent progression to acute respiratory distress syndrome.

https://seekingalpha.com/news/3586019-dosing-underway-in-mid-stage-study-of-theravance-drug-for-covidminus-19