Vitae Enters Phase II Clinical Trials

Vitae Pharmaceuticals, Inc.announced today that it has initiated Phase II clinical studies with VTP-201227 for the treatment of psoriasis and VTP-195183 to enhance immune celllevels in specific cancer treatments. "Within the last 18 months, Vitae has progressed multiple products intoPhase II trials, created a significant partnership with GlaxoSmithKline, andexpanded our robust pipeline of discovery projects," said Jeffrey Hatfield,CEO of Vitae Pharmaceuticals. "We now have significant development efforts inthree major disease areas, including oncology, dermatology and hypertension.The speed of our progress demonstrates the ability of our team, our uniqueapproach and the strength of our drug discovery capabilities and proprietarytechnologies." The first Phase II clinical compound, VTP-201227, has a novel mechanism ofaction and is being developed at Vitae Pharmaceuticals as a topical agent forthe treatment of psoriasis with potential extensions into other dermatologicalindications. The Phase II trial is designed to include 128 psoriasis patientsat 16 study sites in the U.S. The first psoriasis patient was enrolled anddosed in the study this month. VTP-201227 is a potent, selective inhibitor of two specific enzymes thatare active in the skin. Therapeutic targeting of these enzymes by VTP-201227promotes naturally-occurring healing processes within the skin. The compoundhas been designed to be rapidly inactivated in systemic circulation and thushas the potential to have a more favorable safety profile. In preclinicalanimal models, VTP-201227 was shown to exhibit a superior therapeutic indexcompared to other topical dermatology drugs. The second Phase II clinical compound, VTP-195183, is being studied incombination with other therapies for its potential to boost the levels ofinfection-fighting white blood cells in certain oncologic conditions. Vitaeadvanced the clinical program for this compound and initiated a Phase IIclinical trial in October. The Phase II trial is designed as a proof-of-biology study to determine the effectiveness of VTP-195183 in combination withGranulocyte Colony Stimulating Factor (G-CSF) to enhance mobilization ofperipheral blood progenitor cells in patients for whom high-dose chemotherapyis planned. VTP-195183 is a novel subtype-specific nuclear receptor agonistthat has been shown to be generally safe and well tolerated in cancer patientsin Phase I studies. The Phase II clinical trial of VTP-195183 is beingconducted outside of the U.S.