Theravance Biopharma, Inc. (TBPH - Free Report) has dosed the first patient in a phase IIb/III study on its gut-selective pan-Janus kinase (JAK) inhibitor, TD-1473 in patients with moderately to severely active ulcerative colitis. TD-1473 is currently being developed in collaboration with Janssen, a subsidiary of Johnson & Johnson (JNJ - Free Report) , for treating inflammatory intestinal diseases.
The phase IIb dose-finding induction portion of the study will assess the effect of eight weeks of treatment with select once-daily doses of TD-1473 on change from baseline in total Mayo score as the primary endpoint. The phase IIb portion of the study will also assess rates of clinical response and remission, endoscopic mucosal healing, safety, and tolerability.
Based on the efficacy, safety and tolerability findings from the dose-finding portion of the study, one or more doses of TD-1473 will be selected and evaluated in the phase III induction portion of the study, with primary objectives of assessing clinical remission rates with TD-1473 compared to placebo at week 8, and safety and tolerability of the candidate.
The patients who receive clinical responses during the induction stage of the study, either from the phase IIb or phase III portion of the study, will then be immediately enrolled in the phase III maintenance portion of the study.
Shares of the company have decreased 18.9% in the past year compared with the industry’s decline of 16.5%.
We would like to remind investors that in February 2018, Theravance entered into a global co-development and commercialization agreement with Janssen to evaluate TD-1473 for treating inflammatory intestinal diseases, such as ulcerative colitis and Crohn's disease. Theravance received an upfront payment of $100 million and is eligible to receive another $900 million as potential payments, if Janssen decides to continue the collaboration following the completion of phase II activities. Both the companies will be sharing profits and expenses in the United States related to a potential phase III study.
The initiation of the phase IIb/III study of TD-1473 in ulcerative colitis follows the previously-announced initiation of a phase II study in patients with Crohn's disease.
Some marketed ulcerative colitis treatments include Pfizer’s (PFE - Free Report) JAK inhibitor, Xeljanz and AbbVie’s (ABBV - Free Report) Humira.
Theravance currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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