Theravance Biopharma, Inc. TBPH announced that it has submitted an investigational new drug (IND) application to the FDA to conduct a phase I single-ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.
The company is working to develop a best-in-class selective neprilysin (NEP) inhibitor for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. TD-0714 is the lead NEP inhibitor candidate at Theravance Biopharma. Subject to FDA action on the IND, the company plans to initiate the phase I study in the fourth quarter of 2015.
TD-0714 has the potential to be administered once daily and can be combined with other approved drugs or candidates. Theravance Biopharma is looking for a partner for the development and commercialization of TD-0714 and is currently engaged in active discussion with a number of potential collaborators.
We are pleased with the pipeline advancement at Theravance Biopharma. Last month, the company initiated a phase III registrational program on revefenacinIn (TD-4208), a key late-stage pipeline candidate, for the treatment of chronic obstructive pulmonary disease. Theravance is collaborating with Mylan MYL for the development and commercialization of revefenacinIn.
Theravance Biopharma carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Amgen Inc. AMGN. Both Anika and Amgen hold a Zacks Rank #1 (Strong Buy).
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