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Theravance Doses First Patient in Phase II Coronavirus Study

Zacks Equity Research
·3 min read

Theravance Biopharma, Inc. TBPH announced that it has dosed the first patient in a phase II study evaluating its lung-selective, nebulized Janus kinase inhibitor (JAKi), TD-0903, for the potential treatment of hospitalized patients with acute lung injury (ALI) caused by COVID-19.

The initiation of the above-mentioned phase II study in patients in the United Kingdom comes after the successful completion of dosing in the phase I study in healthy volunteers at the same clinical unit.

Per the company, the study consists of two parts. The first will assess the safety, tolerability and clinical response in ascending doses administered to hospitalized patients with each being dosed for seven days. The second part will be a larger, multi-center study, which will be conducted in the United Kingdom as well as across European countries and the United States.

In April 2020, Theravance announced that it is pushing TD-0903 into clinical development to assess the candidate's utility in preventing the cytokine storm associated with ALI in patients hospitalized due to COVID-19 for preventing progression to acute respiratory distress syndrome (ARDS). Back then, the company had submitted a clinical trial application (CTA) in the United Kingdom for the first-in-human study of TD-0903.

During the same month, Theravance dosed the first healthy volunteer in a phase I study on TD-0903 for the given indication.

Shares of Theravance have declined 16.5% so far this year compared with the industry’s decrease of 6.2%.

We note that the COVID-19 outbreak already infected more than 9.5 million people with the death toll having crossed 480,000 globally.

Notably, the entire world is hoping for a rapid development of a treatment/antibody to treat COVID-19 or a vaccine to prevent the disease.

Earlier this month, FibroGen, Inc. FGEN initiated a phase II study, evaluating the efficacy and safety of pamrevlumab in hospitalized patients with acute COVID-19 infection.

Several marketed drugs like Roche’s RHHBY IL-6 inhibitor Actemra, AstraZeneca’s AZN BTK inhibitor Calquence, Incyte/Novarts’ JAK1/JAK2 inhibitor Jakafi, Amgen’s PDE4 inhibitor Otezla, Sanofi/Regeneron’s IL-6 inhibitor Kevzara among others are being evaluated to treat respiratory complications associated with COVID-19.

Zacks Rank

Theravance currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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