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Actionable news in VTAE: VITAE PHARMACEUTICALS Inc,

Vitae Pharmaceuticals: Fort Washington, Pa, November 18, 2015

The following excerpt is from the company's SEC filing.

Vitae Pharmaceuticals, Inc. (NASDAQ:VTAE), a clinical-stage biotechnology company, today reported positive top-line results from the healthy human volunteer part of the multiple ascending dose Phase 1 clinical trial of VTP-43742. VTP-43742 is Vitaes wholly owned, orally active ROR

t inhibitor with the potential to transform the treatment of multiple autoimmune disorders, including psoriasis, through the potent inhibition of IL-17 secretion from Th17 cells and blocking the action of IL-23.

In this double-blind, randomized, placebo-controlled trial examining the safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple oral doses of VTP-43742 in 40 healthy human volunteers, VTP-43742 was shown to be safe and generally well tolerated at all dose levels assessed. No serious adverse events were reported, and all study subjects completed the full 10 days of dosing. Vitae saw no drug-related clinical laboratory or electrocardiogram (ECG) abnormalities. Additionally, dose proportionality was demonstrated across all dose levels tested, and the half-life was consistent with once-a-day dosing.

In an

ex vivo

assay, VTP-43742 was also shown to suppress the ROR

t dependent production of the pro-inflammatory cytokine IL-17A in blood obtained from study subjects. Those who received VTP-43742 showed a dose-dependent suppression of IL-17A production by more than 90 percent sustained for a full 24 hours in all but the lowest dose cohort. These results are consistent with the suppression of IL-17 production seen in Vitaes single ascending dose clinical trial of VTP-43742 in healthy human volunteers, for which results were disclosed in September 2015.

This clinical trial in healthy human volunteers is one part of Vitaes Phase 1 multiple ascending dose trial of

VTP-43742. Top-line clinical efficacy results from the second part of the Phase 1 clinical trial, which is a proof-of-concept trial in patients with moderate to severe psoriasis, are expected in the first quarter of 2016.

Vitae Pharmaceuticals, Inc.

Tel: (215) 461-2000

502 West Office Center Drive

Fax: (215) 461-2006

Fort Washington, PA 19034

www.vitaepharma.com

We continue to be very encouraged by the inhibition of IL-17 production that VTP-43742 has shown in our Phase 1 trials, along with its favorable safety and tolerability profile, said Dr. Richard Gregg, Chief Scientific Officer of Vitae. These

ex vivo

results, combined with those seen in Vitaes previously disclosed single ascending dose trial, reaffirm our belief that VTP-43742s mechanism of action has the potential to safely and effectively treat psoriasis and an

array of other autoimmune diseases. We look forward to obtaining top-line clinical proof-of-concept data from our trial in psoriasis patients in...


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