Theravance Biopharma said that it has submitted a clinical trial application (CTA) to begin clinical development of its TD-0903 nebulized JAK inhibitor for prevention of cytokine storm, which can lead to acute respiratory distress syndrome (ARDS), in hospitalized patients with COVID-19. Theravance initially planned to develop TD-0903 for the prevention of graft rejection in lung transplant patients. According to the company, preclinical studies have shown that TD-0903 could potentially block the release of cytokines and chemokines associated with cytokine storm using once or twice daily doses.
Theravance notes that TD-0903 works in a similar manner to the company’s TD-8236 JAK inhibitor DPI, which is in Phase 2 clinical development for the treatment of moderate to severe asthma. The company said that, “Insights from the ongoing clinical development of TD-8236 DPI are informing the Company’s confidence to bring TD-0903 forward for the treatment of COVID-19 acute lung injury.”
If its CTA is approved, the company says that it would quickly initiate a Phase 1 SAD/MAD study in the UK, with plans to advance to a 2-part Phase 2 study in hospitalized COVID-19 patients. The first part of the study, designed for dose selection, would take place in the UK, and the second part of the study could possibly add sites in the US and EU, subject to approval by the FDA and EMA.
Theravance Chief Medical Officer Brett Haumann said, “We are pleased to be able to direct our resources and expertise towards helping to treat COVID-19. Janus kinase inhibitors have the potential to inhibit a broad set of immune-modulatory pathways that could prove to be effective in dampening the abnormal immune response that occurs in the lungs of some patients. The nebulized formulation of our lung-selective inhaled JAK inhibitor will allow TD-0903 to be administered directly to the lung in a number of hospitalized settings, including patients who can breathe unaided in the ward, as well as in the ICU setting in patients who require non-invasive or mechanical ventilation. If our initial CTA submission for this study in healthy volunteers is approved and the study is successful, we intend to study TD-0903 in COVID-19 patients in the very near future. We are proud of the tremendous efforts of the global team of Theravance Biopharma scientists and physicians that has enabled us to rapidly progress TD-0903, and we are grateful for their collaboration and dedication to continue its advancement.”
CEO Rick E Winningham commented, “In response to the unprecedented healthcare challenges presented by the emergence of COVID-19, we have combined our immunology and respiratory medicine expertise to accelerate development of our nebulized lung-selective JAK inhibitor, TD-0903. With great urgency, we have redirected our program to treat the acute lung injury caused by COVID-19. We recognize how critical it is to help those suffering from shortness of breath and low oxygen levels, including those who need intensive care and ventilation, to address the effects of profound lung hyperinflammation. TD-0903 could provide benefit to hospitalized patients by preventing the progression of lung hyperinflammation and reducing the requirement for, or the duration of, assisted ventilation. As a result, this could improve utilization of limited hospital critical care resources.
Read the Theravance Biopharma press release.
