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
Theravance Biopharma aims to transform the treatment of serious diseases through the discovery and development of organ-selective medicines designed to maximize patient benefit while minimizing patient risk.
Our research is focused in the areas of inflammation and immunology, and our pipeline of internally discovered programs is targeted to address significant patient needs.
Theravance Biopharma is a place for collaborators and creative problem-solvers – people who thrive on applying insight and innovation to discovering novel medicines.
Learn how our dedication to patients expands beyond the laboratory.
Our integrated team is committed to developing and providing the world with organ-selective medicines for serious diseases.
We leverage insight and innovation to transform the treatment of serious diseases.
