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|Vitae Pharmaceuticals Announces Initiation of a Phase 1 Single Ascending Dose Study of VTP-43742 in Autoimmune Disorders|
This single ascending dose trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of VTP-43742 in healthy human volunteers, with results expected in the second half of 2015. The Company also intends to initiate an overlapping Phase 1 multiple ascending dose, proof-of-concept clinical trial of VTP-43742 in the third quarter, which will include patients with moderate to severe psoriasis. Top-line clinical efficacy results from this second clinical trial are expected by the end of the year.
"The initiation of this Phase 1 study of our wholly owned first-in-class RORγt inhibitor is a very important milestone both for Vitae and for patients afflicted with autoimmune disorders," said Dr.
About Autoimmune Disorders
Autoimmune disorders, where the immune system attacks normal tissue, make up a large number of human disorders including psoriasis, multiple sclerosis, rheumatoid arthritis and steroid-resistant asthma, as well as rare or orphan disorders. Increased activity of a class of lymphocytes called Th17 cells and excess production of pro-inflammatory proteins, including Interleukin 17, or IL-17, by these cells are critical parts of the pathophysiology of many human autoimmune disorders. RORγt is a nuclear hormone receptor that is essential for the formation and function of Th17 cells.
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-43742. 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