Theravance Biopharma, Inc. 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).
The 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.
The 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.
“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 Professor Ashley Woodcock, Chairman of the Medicines Evaluation Unit (MEU) conducting the Phase 1 and Phase 2 studies, Associate Dean for Clinical Affairs, Professor of Respiratory Medicine, University of Manchester and Consultant Physician, NW Lung Centre, Manchester University NHS Foundation Trust.i “We are pleased to be leading the clinical trial on behalf of Theravance Biopharma to efficiently evaluate the safety and efficacy of TD-0903 in this patient population to inform its potential role in the fight against COVID-19.”
“Working with the Medicines Evaluation Unit over the past few months has once again been an outstanding experience as we mobilized our response to COVID-19. The initiation of the Phase 2 study of TD-0903 is a significant milestone in our ongoing efforts to apply our organ-selective therapies and expertise to treat inflammatory conditions,” said Rick E Winningham, Chief Executive Officer at Theravance Biopharma. “Theravance Biopharma has a long history of developing lung-selective medicines to treat respiratory disease, and we are proud to leverage this experience and expertise to respond to the current pandemic.”