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 ROR?t inhibitor is a very important milestone both for Vitae and for patients afflicted with autoimmune disorders," said Dr. Richard Gregg, Chief Scientific Officer of Vitae.
"We believe that VTP-43742’s unique mechanism of action has the potential to provide patients with a safe, effective and convenient oral treatment option for a variety of autoimmune disorders."
VTP-43742 is Vitae Pharmaceuticals’ wholly owned product candidate for the treatment of a variety of autoimmune disorders. In preclinical studies, VTP-43742 demonstrated potent inhibition of IL-17 secretion from Th17 cells, was highly selective versus other ROR isotypes, and has a predicted human oral dosing schedule of once-a-day.
VTP-43742 also demonstrated superiority in an animal model of multiple sclerosis in direct comparison to an IL-17A monoclonal antibody.
Vitae has filed an Investigational New Drug Application with the U.S. Food and Drug Administration for VTP-43742 and initiated a Phase 1 single ascending dose clinical trial in healthy human volunteers to assess safety, tolerability, pharmacokinetics and pharmacodynamics.