Theravance Biopharma, Inc. TBPH announced the initiation of a phase IIb study on velusetrag (TD-5108), which is being developed for the treatment of patients with gastroparesis and other gastrointestinal motility disorders.
The multicenter, double-blind, randomized, placebo-controlled, parallel-group phase IIb study will evaluate the efficacy and safety of different doses (5, 15, and 30 mg once daily) of velusetrag compared to placebo in patients suffering from diabetic or idiopathic gastroparesis.
Theravance Biopharma has an agreement with Alfa Wassermann for velusetrag. Under the terms of the agreement, Alfa Wassermann funds a major portion of the costs of the phase II costs and has the exclusive option to develop and commercialize velusetrag in the EU, Russia, China, Mexico and certain other countries. Meanwhile, Theravance Biopharma retains full rights to velusetrag in the U.S., Canada, Japan and certain other countries.
According to the company press release, gastroparesis affects nearly 5.8 million people in U.S. alone.
We note that Ironwood Pharmaceuticals IRWD is also developing a candidate (IW-9179) for diabetic gastroparesis. IW-9179 is currently being evaluated in a phase IIa study with results expected in the first half of 2016.
Apart from velusetrag, other important candidates in Theravance Biopharma’s pipeline include TD-4208, which is being developed for the treatment of chronic obstructive pulmonary disease. The company intends to move the candidate into phase III development this year. Last month, the company had entered into an agreement with Mylan MYL to develop and commercialize the nebulized formulation of TD-4208.
We are also encouraged by the company’s efforts to expand the label of its only approved drug, Vibativ (Staphylococcus aureus and other Gram-positive bacteria infections). Last month, the company initiated a phase III registrational study that will evaluate the drug as a treatment for Staphylococcus aureus bacteremia.
Theravance Biopharma carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is Lannett Company, Inc. LCI, sporting a Zacks Rank #1 (Strong Buy).
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