Vitae Pharmaceuticals Initiates Second Part of a Phase 1 Multiple Ascending Dose Study of VTP-43742 in Psoriatic Patients

Vitae Pharmaceuticals, Inc. VTAE, a clinical-stage biotechnology company, today announced that it has initiated the second part of its Phase 1 multiple ascending dose clinical trial of VTP-43742 in psoriatic patients. VTP-43742 is the Company's wholly owned and first-in-class RORt inhibitor product candidate for the treatment of autoimmune disorders, potentially including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan diseases. In this proof-of-concept study, Vitae will evaluate 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 a percent change from baseline in the PASI (Psoriasis Area and Severity Index) score at four weeks. Top-line clinical efficacy results are expected by the end of 2015. This proof-of-concept part of the Phase 1 multiple ascending dose trial overlaps with the first part of the study currently being conducted in healthy human volunteers, which the Company initiated in August 2015. "The initiation of this second part of our multiple ascending dose proof-of-concept trial marks Vitae's first assessment of the clinical efficacy of our novel and first-in-class RORt inhibitor in a psoriatic patient population. This is a major step for the Company, and for determining whether VTP-43742 can provide a safe, effective and convenient oral treatment option for this patient population whose needs may not be satisfied by the current standards of care," said Dr. Richard Gregg, Chief Scientific Officer of Vitae.