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Theravance (TBPH) Starts Dosing in Ulcerative Colitis Study

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Theravance Biopharma, Inc. (TBPH - Free Report) announced the dosing of the first patient, in the multi-center, randomized, double-blind, multi-dose, placebo-controlled phase Ib study on TD-1473, in patients with moderate-to-severe ulcerative colitis.

The study is being conducted with the primary goals of evaluating the safety and tolerability of TD-1473 given for 28 days and assessing the candidate's plasma exposure subsequent to administration. Data from this study should be out in mid-2017.

In Jun 2016, Theravance had reported positive data from a phase I study that was conducted on TD-1473 in healthy volunteers. Data showed that the candidate was found to be well tolerated as a single dose (up to 1000 mg) and as a daily dose (up to 300 mg) when administered for 14 days. On the safety front, no serious adverse events were reported.


We are encouraged by Theravance’s progress with the candidate. The company is focused on using targeted JAK inhibitors for the treatment of a range of inflammatory intestinal diseases, including ulcerative colitis, which affects approximately 700,000 patients in the U.S.

Note that TD-1473 is an intestinally restricted pan-JAK inhibitor that has been designed to act directly at the site of inflammation, in the intestinal wall, while minimizing systemic exposure.

Apart from TD-1473, Theravance’s pipeline includes promising candidates like revefenacin. Currently, revefenacin is being evaluated in a phase III program as a once-daily, nebulized treatment for chronic obstructive pulmonary disease.

Zacks Rank & Key Picks

Theravance currently carries a Zacks Rank #2 (Buy). Some favorably ranked stocks in the health care sector include Anika Therapeutics Inc. (ANIK - Free Report) , Ophthotech Corporation (OPHT - Free Report) and Geron Corporation . All the three stocks sport a Zacks Rank #1 (Strong Buy) stock. You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika has seen its earnings estimates for 2016 rise 9.5% over the last 60 days. It has recorded an average positive earnings surprise of 42.19% over the last four trailing quarters. The company’s shares have jumped almost 23% year to date.

Ophthotech has posted an average positive surprise of 9.31% over the last four trailing quarters.

Geron has posted an average positive surprise of 20.78% over the last four trailing quarters.

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