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The company is advancing its lung-selective nebulized Janus kinase inhibitor into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19.
Theravance Biopharma, a biopharmaceutical company with locations in Ireland and San Francisco, CA, announced on April 9, 2020 that it is advancing its lung-selective nebulized Janus kinase inhibitor (JAKi), TD-0903, into clinical development to determine its ability to prevent acute lung injury in patients with COVID-19, with the goal of inhibiting progression to acute respiratory distress syndrome.
According to a company press release, the company will initiate a Phase-I study this month in the United Kingdom with single- and multiple-ascending doses in healthy patients to determine the safety of the JAKi. After regulatory review and approval, the program will transition to a Phase-II study in hospitalized patients with COVID-19 to determine the safety, tolerability, and clinical response to treatment.
“We are pleased to be able to direct our resources and expertise towards helping to treat COVID-19," said Brett Haumann, MD, chief medical officer, Theravance, in the press release. "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 [clinical trials application] 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.”
"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," said Rick E. Winningham, CEO, Theravance, in the press release. "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."