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Theravance JAK Inhibitor Enters Phase II for Crohn's Disease

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Theravance Biopharma, Inc. (TBPH - Free Report) announced that it has dosed the first patient in a phase II study on its gut-selective pan-JAK inhibitor, TD-1473 for the treatment of patients with Crohn's disease. TD-1473 is currently being developed in collaboration with Janssen, a subsidiary of Johnson & Johnson (JNJ - Free Report) , for treating inflammatory intestinal diseases.

The randomized, placebo-controlled phase II study will evaluate the efficacy, safety and tolerability of TD-1473 in patients with moderate to severe active Crohn's disease. Patients will be administered with either one of the two active doses of TD-1473 or placebo once daily for up to 12 weeks. The primary endpoint of the study is to see the improvement in Crohn's Disease Activity Index (CDAI) score at 12 weeks.

Shares of Theravance have lost 11.1% year to date compared with the industry’s decline of 9.7%.

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.

Theravance is also evaluating TD-1473 in phase Ib study for the treatment of ulcerative colitis. Last month, the company announced data from the exploratory phase Ib study on TD-1473 for the treatment of patients with moderate-to-severe ulcerative colitis. Data from the study showed that treatment with TD-1473 led to signals of biological activity suggesting localized target engagement in patients following four weeks of treatment. Moreover, the study showed that the candidate was well tolerated with a favorable safety profile. Following this encouraging result, Theravance plans to initiate a phase IIb/III induction and maintenance study on TD-1473 in the same indication by the end of 2018 or early 2019.

Another interesting candidate in Theravance’s portfolio is TD-9855, which is currently under inspection for addressing symptomatic neurogenic orthostatic hypotension (nOH). In August, the company announced a positive top-line outcome from the phase II study on the candidate. Additionally, Theravance expects to initiate a registrational phase III study in late 2018 or early 2019.

Theravance is focused on advancing both TD-1473 and TD-9855 into late-stage developmental studies.

Zacks Rank & Stocks to Consider

Theravance currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the same sector are BioSpecifics Technologies Corp (BSTC - Free Report) and Hikma Pharmaceuticals Plc (HKMPF - Free Report) , both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has rallied 29.7% year to date.

Hikma Pharmaceuticals’ earnings estimates have moved 15% north for 2018 and 10.1% for 2019 over the past 60 days. The stock has soared 59% so far this year.

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