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Theravance (TBPH) COVID-19 Therapy Fails in Mid-Stage Study

Theravance Biopharma, Inc. TBPH announced that a phase II study evaluating its inhaled JAK-inhibitor candidate, nezulcitinib, in hospitalized COVID-19 patients with lung injury failed to meet its primary endpoint.

The study evaluated once-daily 3mg dose of the candidate, in combination with standard-of-care, administered for seven days as a potential treatment for hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation. Data from the study showed that treatment with the candidate failed to achieve statistical significance in number of respiratory failure-free days compared to placebo at day 28. Moreover, there was no change in SaO2/FiO2 ratio, a tool to measure lung injury, as well as in proportion of patients alive and with no respiratory failure from baseline after seven days of treatment.

However, Theravance pointed out that treatment with nezulcitinib demonstrated a favorable trend in improving all-cause mortality rate and improvement in median time to recover compared to placebo at day 28.

Per data from a post-hoc analysis of the mid-stage study, treatment with nezulcitinib of patients with C-reactive protein (CRP) levels less than 150 at baseline achieved improvement in 28-day all-cause mortality. While one patient died in the nezulcitinib-arm, there were nine deaths in the placebo-arm in this patient population of the study. Moreover, median time to recover declined from 11 days for placebo to 10 days for the candidate.

The company believes that nezulcitinib may hold potential as a treatment of acute hyperinflammation of the lung caused due to factors other than COVID-19. The candidate may also help in the prevention or delay of lung transplant rejection. The company will share the study data with the FDA and other regulatory agencies and will seek input to assess further evaluation of the candidate in acute hyperinflammation in the lung.

Shares of Theravance have declined 1.1% so far this year compared with the industry’s decrease of 9.8%.

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Apart from nezulcitinib, the company has several other candidates in its pipeline. The most advanced candidate, ampreloxetine, is currently being evaluated in a phase III study for treating patients with symptomatic neurogenic orthostatic hypotension. Top-line results from the study are expected in the third quarter of 2021. This is likely to be a key catalyst for the company’s share price, as positive data may lead to submission of a new drug application. Following a potential approval, the candidate will be the first marketed drug in its portfolio.

Theravance is also developing its another JAK inhibitor candidate, izencitinib, for the treatment of inflammatory intestinal diseases, including Crohn's disease and ulcerative colitis in mid-stage studies.

Meanwhile, the company earns revenues from its collaboration with J&J JNJ and Viatris VTRS. Moreover, it also holds an economic interest in royalties earned from GlaxoSmithKline GSK by Innoviva on the triple combination COPD treatment, Trelegy Ellipta’s global sales.

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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