Vitae Pharmaceuticals, Inc. Initiates Phase II Clinical Trials For Two Novel Compounds For Psoriasis And Cancer Conditions

FORT WASHINGTON, Pa., Nov. 29 /PRNewswire/ -- 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 cell levels in specific cancer treatments.

“Within the last 18 months, Vitae has progressed multiple products into Phase II trials, created a significant partnership with GlaxoSmithKline, and expanded our robust pipeline of discovery projects,” said Jeffrey Hatfield, CEO of Vitae Pharmaceuticals. “We now have significant development efforts in three major disease areas, including oncology, dermatology and hypertension. The speed of our progress demonstrates the ability of our team, our unique approach and the strength of our drug discovery capabilities and proprietary technologies.”

The first Phase II clinical compound, VTP-201227, has a novel mechanism of action and is being developed at Vitae Pharmaceuticals as a topical agent for the treatment of psoriasis with potential extensions into other dermatological indications. The Phase II trial is designed to include 128 psoriasis patients at 16 study sites in the U.S. The first psoriasis patient was enrolled and dosed in the study this month.

VTP-201227 is a potent, selective inhibitor of two specific enzymes that are active in the skin. Therapeutic targeting of these enzymes by VTP-201227 promotes naturally-occurring healing processes within the skin. The compound has been designed to be rapidly inactivated in systemic circulation and thus has the potential to have a more favorable safety profile. In preclinical animal models, VTP-201227 was shown to exhibit a superior therapeutic index compared to other topical dermatology drugs.

The second Phase II clinical compound, VTP-195183, is being studied in combination with other therapies for its potential to boost the levels of infection-fighting white blood cells in certain oncologic conditions. Vitae advanced the clinical program for this compound and initiated a Phase II clinical trial in October. The Phase II trial is designed as a proof-of- biology study to determine the effectiveness of VTP-195183 in combination with Granulocyte Colony Stimulating Factor (G-CSF) to enhance mobilization of peripheral blood progenitor cells in patients for whom high-dose chemotherapy is planned. VTP-195183 is a novel subtype-specific nuclear receptor agonist that has been shown to be generally safe and well tolerated in cancer patients in Phase I studies. The Phase II clinical trial of VTP-195183 is being conducted outside of the U.S.

About Psoriasis

In the United States, psoriasis affects approximately 4.5 million adults and the annual costs for drug treatment approach $1 billion. The choice of therapy is based on disease severity. More than two-thirds of patients have a mild to moderate form of the disease, which can be treated by topical therapies. Systemic treatments, including novel biological agents, are limited to those who have the severe form of the disease.

About White Blood Cell Counts in Cancer Patients

In cancer patients, chemotherapy can cause blood disorders as it destroys normal cells, including a certain type of white blood cell, called neutrophils, which help the body fight infection. Each year, approximately half of the estimated 1.6 million chemotherapy patients in the U.S. develop lower-than-normal white blood cell counts, placing them at risk for serious infections and potentially postponing chemotherapy and other needed treatments.

About Vitae Pharmaceuticals

Vitae Pharmaceuticals is an emerging pharmaceutical company dedicated to the discovery and development of innovative drugs by advancing its pipeline of product candidates. Vitae is uniquely able to discover innovative compounds by accelerating and enhancing the drug discovery skills and experience of proven drug hunters with world-class, proprietary drug design technologies developed in collaboration with Intel Corporation. Vitae Pharmaceuticals is financed by leading corporate and venture capital investors and is headquartered in Fort Washington, Pennsylvania. For additional information, please visit the company’s website, http://www.vitaepharma.com.

Vitae Pharmaceuticals, Inc.

CONTACT: Kathryn Morris of KMorris PR, +1-845-635-9828, for VitaePharmaceuticals

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