Exhibit 99.1

 

 

Vitae Pharmaceuticals Reports Fourth Quarter and Full Year 2015
Operating and Financial Results

 

Proof-of-concept data for VTP-43742 expected in the first quarter of 2016

 

Initiated proof-of-concept trial of VTP-38543 in patients with atopic dermatitis

 

Conference call scheduled for 4:30 p.m. EST today

 

FORT WASHINGTON, PA, March 3, 2016 —

Vitae Pharmaceuticals, Inc. (NASDAQ: VTAE), a clinical-stage biotechnology company, today reported its operating and financial results for the fourth quarter and full year ended December 31, 2015.

 

Jeff Hatfield, President and Chief Executive Officer of Vitae, commented, “Our accomplishments during the fourth quarter and full year of 2015 position Vitae to deliver proof-of-concept data for both of our lead product candidates in 2016. Results for VTP-43742, our wholly owned, first-in-class RORγt inhibitor being developed for moderate to severe psoriasis, are expected to be disclosed in the first quarter of 2016. We anticipate results for VTP-38543, our wholly owned, potential first-in-class LXRβ selective agonist being developed for atopic dermatitis, in the second half of 2016.”

 

Quarterly and Recent Highlights

 

Pipeline Updates:

 

VTP-43742 in Autoimmune Disorders

 

·      Reported positive top-line results from the healthy human volunteer multiple ascending dose clinical trial of VTP-43742. 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. No serious adverse events were reported, and all study subjects completed the full 10 days of dosing. In an ex vivo assay, VTP-43742 suppressed the RORγt 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.

 

·      Advanced the second part of a multiple ascending dose, clinical proof-of-concept trial of VTP-43742 in psoriatic patients. In this study, Vitae is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple ascending doses of VTP-43742 in patients with moderate to severe psoriasis. The primary endpoint measure will be percent change from baseline in the PASI (Psoriasis Area and Severity Index) score at four weeks. The Company has closed enrollment at 34 psoriatic patients and believes that the totality of the data from the 34 psoriatic patients, including clinical efficacy and accelerated biomarker data, will be sufficient to determine next steps in the program. Vitae is currently analyzing the data and expects to announce top-line clinical efficacy and preliminary biomarker results by the end of 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

 


The following information was filed by Vitae Pharmaceuticals, Inc (VTAE) on Thursday, March 3, 2016 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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