Theravance Biopharma Announces Dosing of First Subject in Clinical Trial

Theravance Biopharma, Inc. (NASDAQ: TBPH) reported the dosing of its first subject in a Phase 1 clinical trial of the company’s lead drug candidate TD-0714.
According to the press release:

This program is designed to develop best-in-class selective NEP inhibitors 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 an internally-discovered selective inhibitor of NEP, the enzyme responsible for degradation of natriuretic peptides ANP, BNP and CNP. By inhibiting NEP, TD-0714 elevates the levels of these peptides, which may exert protective cardiac and renal effects including vasodilation, diuresis, natriuresis, reversal of maladaptive changes in heart, blood vessels and kidney, prevention of fibrosis, and prevention of end-organ damage. Theravance Biopharma has specifically designed TD-0714 to possess certain key features, including low renal clearance, the potential to be administered once daily, and the flexibility to be combined with other approved and investigational drugs.
The Phase 1 trial is a randomized, double-blind, placebo-controlled, single-ascending dose study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714. The single-center study’s primary endpoints will be the safety and tolerability of TD-0714 in healthy adults. Key secondary endpoints are designed to assess the potential for once-daily dosing and include an assessment of the pharmacodynamics of TD-0714 and the pharmacokinetic half-life. Investigators will also assess TD-0714’s potential for low levels of renal clearance.
“The initiation of this first-in-human clinical trial is the next step in our efforts to develop a best-in-class collection of NEP inhibitors with the flexibility to be combined with a range of other mechanistic classes to potentially deliver enhanced outcomes to patients with a range of cardiovascular and renal diseases. Importantly, our preclinical data presented at the 2015 American Heart Association conference support our belief that several of our NEP inhibitors have attractive biological and pharmacokinetic properties with significant therapeutic potential,” said Mathai Mammen, M.D., Ph.D., Senior Vice President, Research and Development of Theravance Biopharma. “We believe TD-0714 is an exciting compound with uniquely designed characteristics. In addition, it is just the first in a series of novel NEP inhibitors that have been created at Theravance Biopharma. We are working aggressively to advance additional compounds from this program into the clinic and look forward to achieving key development milestones with those drug candidates as well.”

Click here to read the full press release.