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Theravance Biopharma Announces First Patient Dosed in Phase 2 Study of TD-0903 for the Treatment of Hospitalized Patients with Acute Lung Injury Caused by COVID-19
DUBLIN and SOUTH SAN FRANCISCO, Calif., June 25, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company"), a
About this update from Theravance Biopharma, Inc.
[{"type":"text","content":"DUBLIN and SOUTH SAN FRANCISCO, Calif., June 25, 2020 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) (\"Theravance Biopharma\" or the \"Company\"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, today announced that the first COVID-19 patient has been dosed in a Phase 2 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).\n\n \n \n \n \n \n \n\n \nThe initiation of the Phase 2 study in patients in the United Kingdom (UK) follows the successful completion of dosing in the Phase 1 study in healthy volunteers at the same clinical unit in the UK, allowing for a rapid transition to Phase 2. \nThe Phase 2 study consists of two parts. The first part will assess the safety, tolerability and clinical response to treatment in sequential ascending dose cohorts of hospitalized COVID-19 patients, with each patient being dosed for 7 days. Patients will be enrolled if they demonstrate hypoxia (lack of oxygen in the blood) as that is believed to be a marker of underlying hyperinflammation (cytokine storm) in the lung. More information can be found on clinicaltrials.gov, identifier number: NCT04402866. The second part will be a larger, multi-center study conducted at hospital-based clinical sites in the UK, as well as other European countries and in the United States, pending appropriate Ethics Committee and regulatory approvals in those territories. \n\"A subgroup of hospitalized patients with COVID-19 develops Acute Lung Injury due to a dysfunctional immune response to the virus within the lungs resulting in hypoxia which then requires hospitalization, supplemental oxygen and in some cases even mechanical ventilation in the ICU if patients develop Acute Respiratory Distress Syndrome (ARDS). Delivery of a JAK inhibitor directly to the lung could be an important intervention to treat this hyperinflammation and to prevent patients from deteriorating to the point where they need assisted ventilation or ICU admission,\" said Professo...