Theravance Biopharma, Inc. has initiated a Phase I study of TD-0903, a lung-selective, nebulized Janus kinase inhibitor (JAKi) in development for the potential treatment of hospitalized patients with Acute Lung Injury (ALI) caused by COVID-19. TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

The study will assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses of TD-0903 in healthy volunteers and will enroll up to 54 volunteers. Upon regulatory review and approval, the program will then initially move to a Phase II study in hospitalized patients with COVID-19 in the same clinical setting in the UK.

"Theravance Biopharma's efforts to address COVID-19 leverage years of experience in developing lung-selective medicines to treat respiratory disease. We are pleased to have received expedited approval of TD-0903's CTA and are working to progress this potential treatment option through clinical trials as quickly as possible," said Rick E Winningham, Chief Executive Officer. "The clinical site that we are working with has a long history of evaluating our inhaled medicines, and we are proud to be working with them to advance TD-0903 into clinical testing."