Theravance Biopharma, Inc. TBPH announced that a phase IIb study evaluating its oral JAK-inhibitor candidate, izencitinib, failed to meet its endpoints. The study was evaluating the candidate as a potential treatment for patients with ulcerative colitis (UC).
Data from the study showed that treatment with izencitinib failed to meet the company’s expectations and did not meet the primary endpoint of change in the total Mayo score, a measurement of remission in UC patients, at week 8. The study also failed to meet its secondary endpoint of clinical remission. The company plans to present the study data at a future scientific forum. Theravance also plans to analyze the available data as well as future data from the extended induction portion and maintenance studies. It will help the company to analyze the potential to develop an optimized gut-selective medicine for inflammatory bowel diseases including UC.
Shares of Theravance crashed 28% in pre-market trading on Aug 24, following the study failure news. In fact, the company’s shares have declined 20.3% so far this year compared with the industry’s decrease of 13.6%.
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We note that the company is developing izencitinib and other compounds for inflammatory intestinal diseases in collaboration with Janssen Biotech, a subsidiary of J&J JNJ. Theravance is also developing the candidate for the treatment of another inflammatory intestinal disease, Crohn’s disease.
This recent study failure is the second setback for Theravance within two months. In June, the company had announced that its inhaled JAK-inhibitor candidate, nezulcitinib, failed to meet its primary endpoint in hospitalized COVID-19 patients with lung injury.
Meanwhile, 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 earns revenues from its collaboration with J&J 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.
Theravance Biopharma, Inc. Price
Theravance Biopharma, Inc. price | Theravance Biopharma, Inc. Quote
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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