Letter from Rick E Winningham, CEO
March 1, 2021
Dear All,
We are approximately one year into the COVID-19 pandemic and thanks to an unparalleled focus, financial investment, and collaboration between government, the healthcare industry, researchers and scientists, vaccines have been developed in record-breaking time to fight this virus.
Unfortunately, despite the development of vaccines, the COVID-19 pandemic continues. The overall numbers may be decreasing, but the virus causing COVID-19 is unlikely to be eradicated, especially when considering emerging variants. This reality raises the importance of finding treatments for those acutely ill with COVID-19.
As previously shared, the Theravance Biopharma team accelerated TD-0903 – an investigational nebulized lung-selective pan-JAK inhibitor -- from a pre-clinical stage into the clinic last year in response to the global pandemic. TD-0903 is now being studied as an anti-inflammatory to treat patients hospitalized with acute lung injury (ALI) due to COVID-19 who require oxygen. In February, we disclosed encouraging initial clinical data from the first part of a two-part double-blind, placebo-controlled Phase 2 study. While Part 1 enrolled a small number of patients (n=25) and was not powered for efficacy, the study showed numerical improvements in clinical outcomes, shorter hospital stays, and fewer deaths compared to placebo. TD-0903 was generally well-tolerated and demonstrated evidence of improvements in several relevant inflammatory biomarkers, and low systemic exposure at all doses.
Part 1 was a double-blind, placebo-controlled study in contrast to some of the earlier COVID-19 studies, which were open-label - and we allowed all patients, including those on placebo, to be on standard of care treatment, including oxygen, anti-coagulants and dexamethasone. To read our press release, click here, and to view our slides (8-14) in our corporate presentation, click here.
Part 1 informed our confidence to progress to Part 2, a larger placebo-controlled study of 198 patients testing the 3 mg dose of TD 0903 added to standard of care. Part 2 is actively enrolling patients, and we expect to report results in the second quarter of 2021. If the data from Part 1 is ultimately predictive of what we see in Part 2, then TD-0903 may potentially offer an important additional treatment option for hospitalized COVID-19 patients.
Until we have further decreased both the prevalence and deadliness of COVID-19, it remains imperative that we all do our part to keep ourselves and our community safe by continuing to wash our hands, wearing a face mask, not touching our face, wearing protective eye gear and social distancing (at least six feet apart).
Stay safe,

Rick E Winningham, CEO