Vitae Pharmaceuticals, Inc., an integrated discovery and development company, today announced that it has initiated a Phase 1 clinical trial of its novel cardiovascular agent, VTP-27999.
VTP-27999 is a novel, proprietary renin inhibitor discovered and advanced by Vitae. “Renin inhibition offers a powerful approach to blood pressure control because renin is the first and rate limiting enzyme in the primary biochemical pathway for regulating the body’s blood pressure”, said Richard Gregg, MD, chief scientific officer at Vitae. “Also, renin is found in critical organs throughout the body such as the heart, brain and kidney. By inhibiting renin directly, VTP-27999 should provide superior end organ protection versus currently available drug classes.” Recently published human biomarker data support that conclusion. Additional biomarker studies and several long-term morbidity and mortality trials are currently underway with another drug in the class, involving approximately 35,000 patients. This effort makes renin inhibition one of the most intensely studied therapeutic modalities in cardiovascular medicine today.
The Phase 1 trial is a randomized, double blind, placebo controlled study evaluating VTP-27999 in healthy volunteers. The primary objectives of the study are to evaluate the safety, tolerability and pharmacokinetics of VTP-27999 in order to determine doses to be used in subsequent studies. Additionally, Vitae will evaluate pharmacodynamic markers of the biological activity of VTP-27999.
VTP-27999 selectively targets the aspartyl protease enzyme renin, which is the key enzyme regulating the renin-angiotensin pathway, implicated in hypertension. An extremely challenging target, renin has been the focus of industry-wide discovery efforts for more than three decades, with success coming only recently amongst a handful of companies including Vitae.