Theravance Biopharma said that a Phase 1 study of its TD-0903 nebulized JAK inhibitor is now underway. Earlier this month, Theravance announced that it intended to begin clinical development of TD-0903 for the prevention of cytokine storm, which can lead to acute respiratory distress syndrome, in patients hospitalized due to COVID-19.
The Phase 1 SAD/MAD study is taking place in the UK and is expected to enroll as many as 54 healthy volunteers. Assuming that the Phase 1 study is completed successfully, the company plans a 2-part Phase 2 study that will also be conducted in the UK. The second part of that study could also possibly include clinical sites in the US and EU if approved by the relevant regulatory authorities.
Theravance CEO Rick E. Winningham commented, “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. 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.”
Chief Medical Officer Brett Haumann said, “There is accumulating evidence that a subgroup of patients with COVID-19 develop a dysfunctional immune response resulting in a cytokine storm within the lungs. JAK inhibition could be an important intervention to treat this hyperinflammation. TD-0903 has been shown in preclinical studies to have broad pan-JAK inhibition, reducing the signaling of multiple cytokines that have been associated with cytokine storm syndrome. Additionally, the nebulized formulation and organ-selective properties of TD-0903 have the potential to address hyperinflammation in the lung without suppressing the systemic immune system, leading to potential patient benefit and improved utilization of limited hospital critical care resources.”
Read the Theravance Biopharma press release.
