(VTAE) Doses First Patients in Phase 2a Proof-of-Concept of VTP-38543

Top-Line Results Expected in the Second Half of 2016

FORT WASHINGTON, Pa., Dec. 29, 2015  — Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today announced that it has dosed the first patients in its Phase 2a proof-of-concept clinical trial of VTP-38543 in atopic dermatitis (AD). VTP-38543 is the Company’s topical LXRβ selective agonist for the treatment of AD, a skin condition characterized by an intense itch / scratch cycle and driven by both inflammation and a breakdown of the skin’s barrier function.

Earlier this month, Vitae announced plans to initiate this four-week, randomized, double-blind Phase 2a trial, which will assess the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple ascending topical doses of VTP-38543 in approximately 100 adult patients with mild to moderate AD. The Company expects to report top-line results in the second half of 2016.

“Dosing the first patients in this trial brings us closer to gauging VTP-38543’s potential to become a novel therapeutic approach to manage the needs of atopic dermatitis patients, many of which we believe are not being met by currently marketed treatments,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae.

About Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition affecting approximately 17.5 million infants, adolescents and adults in the U.S. It is characterized by intense itching and is caused by both inflammation and a breakdown of the skin’s barrier function. Activation of LXR in skin keratinocytes, the most common cell type in the outer layer of skin, has been shown to increase the formation of corneocytes and the production of lamellar lipids (the ‘bricks and mortar’ of the outer layer of skin). LXR activation also has been shown to have an anti-inflammatory effect in skin equivalent to a high potency corticosteroid. Vitae believes that increasing LXR activity with VTP-38543 may be beneficial for AD patients by both decreasing skin inflammation and repairing the damaged outer layer of skin.

About VTP-38543

VTP-38543 is Vitae’s LXRβ selective agonist with the potential to significantly impact the treatment of atopic dermatitis (AD), a common inflammatory skin disease. In preclinical studies, VTP-38543 was shown to increase LXR activity, decrease skin inflammation, and increase the production and secretion of lipids necessary for maintaining the barrier function, resulting in a potentially superior therapy for AD. In December 2015, Vitae initiated a Phase 2a proof-of-concept clinical trial in patients with mild to moderate AD.

About Vitae Pharmaceuticals

Vitae Pharmaceuticals is a clinical-stage biotechnology company developing first-in-class product candidates with potential to transform the treatment paradigm for patients with significant unmet medical needs. Initial indications being pursued include psoriasis, other autoimmune disorders, and atopic dermatitis. Vitae’s lead clinical assets include VTP-43742, an oral RORyt inhibitor currently being studied in patients with moderate to severe psoriasis, and VTP-38543, an LXRβ selective agonist being studied in patients with mild to moderate atopic dermatitis.

For additional information, please visit the company’s website at www.vitaepharma.com.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the clinical development of VTP-38543. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “impending” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward- looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vitae is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vitae’s forward-looking statements include, among others, the timing and success of preclinical studies and clinical trials conducted by Vitae and its collaborative partners; the ability to obtain and maintain regulatory approval of Vitae’s product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Vitae’s product candidates; the size and growth of the potential markets for Vitae’s product candidates and the ability to serve those markets; Vitae’s expectations regarding Vitae’s expenses and revenue, the sufficiency of Vitae’s cash resources and needs for additional financing; Vitae’s ability to attract or retain key personnel; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Vitae’s Annual Report on Form 10-K for the year ended December 31, 2014 and Vitae’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 which have been filed with the Securities and Exchange Commission (SEC). In addition to the risks described above and in Vitae’s other filings with the SEC, other unknown or unpredictable factors also could affect Vitae’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vitae undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

 

INVESTORS:
Vitae Pharmaceuticals, Inc.
Richard S. Morris, CPA
Chief Financial Officer
(215) 461-2000
rmorris@vitaerx.com

Westwicke Partners
John Woolford
(443) 213-0506
john.woolford@westwicke.com

MEDIA:
6 Degrees PR
Tony Plohoros
(908) 541-2839
tplohoros@6degreespr.com