First Subject Dosed in TD-0903 Study for Acute Lung Injury from COVID-19

Theravance Biopharma announced the first healthy volunteer has been dosed in a Phase 1 study of TD-0903. TD-0903 is 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. The Company believes TD-0903 has the potential to inhibit the cytokine storm associated with ALI and prevent progression to Acute Respiratory Distress Syndrome (ARDS).

Theravance Biopharma received approval of TD-0903's initial Clinical Trial Application (CTA) in the United Kingdom (UK) for the Phase 1 study. The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single- and multiple-ascending doses (SAD/MAD) of TD-0903 in healthy volunteers and will enroll up to 54 volunteers. More information can be found on clinicaltrials.gov, identifier number: NCT04350736. Upon regulatory review and approval, the program will then initially move to a nested Phase 2 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."

"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," said Brett Haumann, M.D., Chief Medical Officer. "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." 

TD-0903 is a lung-selective, nebulized pan-JAK inhibitor that was discovered and developed at Theravance Biopharma. TD-0903 has been shown in experimental murine models to have potent, broad inhibition of JAK-STAT signaling in the airways following challenges with multiple cytokines. By its mechanism, TD-0903 has the potential to block release of cytokines and chemokines that may be associated with acute lung injury and the initiation of a cytokine storm syndrome. Preclinical studies suggest that TD-0903 has a very high lung:plasma ratio and rapid metabolic clearance resulting in low systemic exposure, compatible with its lung selectivity. TD‑0903 is administered via nebulized inhalation solution, which further enhances its lung selectivity. Preclinical pharmacodynamic studies indicate that TD-0903 has an extended duration of action that should enable once or twice daily dosing in humans.
 

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