Fort Washington, PA, November 11, 2011 -- Vitae Pharmaceuticals today announced results
from the Company’s early stage clinical program for VTP‐27999, a novel, potent and selective
renin inhibitor. Data from two separate studies highlight the potential for VTP‐27999 to offer a
significant clinical benefit to patients living with chronic kidney disease. The data will be
presented at Kidney Week 2011, the annual meeting of the American Society of Nephrology
(ASN) being held in Philadelphia, PA from November 8‐13, 2011.
Clinical findings from the Phase 1b multiple ascending dose trial will be presented in a poster
presentation titled, “VTP‐27999: A Novel Direct Renin Inhibitor with Potential for Superior
Renal Protection in Diabetic Nephropathy”. The Phase I study demonstrated VTP‐27999 was
safe and well‐tolerated, and significantly reduced the activity of the renin‐angiotensin‐
aldosterone system (RAAS) in the kidney to a greater extent than any currently available
therapy. Overactivity of the RAAS pathway in the kidney is considered to play a central role in
the progression of chronic kidney disease (CKD), particularly in diabetes.
In a second poster presentation titled, “VTP‐27999 Increases Renal Plasma Flow More Than
Aliskiren,” Harvard University researchers reported that three dose levels of VTP‐27999 used in
a separate Phase I study had a similar or greater effect in increasing renal plasma flow than the
maximum approved clinical dose of aliskiren. Renal plasma flow (RPF) is a biomarker of renal
vascular function, and drugs that increase RPF slow the progression of CKD.
“We are very pleased with the results of the Phase 1 program. These findings are consistent
with our preclinical, in vivo research and confirm the potential for improved renal protection
with VTP‐27999. In addition, these studies have continued to demonstrate the compound is
well‐tolerated, with pharmacokinetic data supporting once‐daily oral dosing,” stated Vitae’s
Chief Scientific Officer, Richard E. Gregg, M.D.
Vitae President and Chief Executive Officer Jeffrey Hatfield said, “Based on these early results
we believe VTP‐27999 has the potential to make a real difference in the lives of patients
suffering from chronic kidney disease. There is a high unmet medical need in chronic kidney
disease which is growing in large part due to the rapidly rising incidence of diabetes around the
globe. We are excited to be rapidly advancing VTP‐27999 and expect to initiate our Phase 2b
study in early 2012.”
About the RAAS Pathway and Chronic Kidney Disease
Renin is the first and rate‐limiting step in the RAAS pathway, the primary pathway for regulating
renal hemodynamics. Over‐activation of the RAAS system is directly linked to the
pathophysiology of chronic kidney disease. Drugs that directly inhibit renin and more effectively block the RAAS pathway are expected to offer improved kidney protection and
improved patient outcomes.
The prevalence of chronic kidney disease has risen more than 25% over the last decade.
Current treatments for diabetic CKD focus on controlling diet and glucose levels with oral drugs
and insulin, and blood pressure through anti‐hypertensive drugs. While these approaches can
slow the development of CKD, patients still progress to end‐stage renal disease (ESRD), which is
life‐threatening and requires aggressive, invasive therapy including hemodialysis and renal
transplantation. VTP‐27999 has been developed specifically for its direct effects in the kidney
to alter the course of CKD.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical‐stage biopharmaceutical company discovering and
developing a portfolio of novel, small molecule, best‐in‐class compounds that address
important disease areas, including: chronic kidney disease, diabetes, Alzheimer’s disease and
atherosclerosis. Vitae’s lead compound, VTP‐27999, is a wholly owned, novel, potent and
selective renin inhibitor offering the potential for superior renal protection in patients suffering
from chronic kidney disease. The compound is expected to enter Phase 2b in early 2012.
Vitae is expert in structure‐based drug discovery and combines a proprietary technical platform
with the experience and insight of world class scientists to advance best‐in‐class compounds for
high value, hard‐to‐drug targets. Vitae’s proprietary, discovery platform has clear advantages
in creating and analyzing novel drug candidates that meet pre‐defined physicochemical and
biochemical characteristics. The accuracy and speed of this system has enabled Vitae to solve
challenging targets in multiple therapeutic areas – discovering and advancing attractive
compounds in a rapid and highly capital efficient manner. Vitae Pharmaceuticals is financed by
leading corporate and venture capital investors; its last venture round was in 2004. Vitae’s 45
scientists are located in Fort Washington, Pennsylvania. For additional information, please visit
the company’s website, www.vitaepharma.com, or contact Burns‐McClellan.
Burns McClellan on behalf of Vitae
Justin Jackson, Michelle Szwarcberg (media)