FORT WASHINGTON, PA, USA I June 29, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced the initiation of a Phase 1 single ascending dose clinical trial of VTP-43742, the Company’s wholly owned and potential first-in-class RORγt inhibitor for the treatment of autoimmune disorders, including psoriasis, multiple sclerosis, and various arthropathies, as well as rare and orphan 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. 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.”
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. Vitae Pharmaceuticals believes inhibition of RORγt activity in Th17 cells will be beneficial for the treatment of multiple autoimmune disorders.
About VTP-43742
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.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including disclosed programs in diabetes, Alzheimer’s disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated internally by Contour(R), Vitae’s proprietary structure-based drug discovery platform.
SOURCE: Vitae Pharmaceuticals
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FORT WASHINGTON, PA, USA I June 29, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced the initiation of a Phase 1 single ascending dose clinical trial of VTP-43742, the Company’s wholly owned and potential first-in-class RORγt inhibitor for the treatment of autoimmune disorders, including psoriasis, multiple sclerosis, and various arthropathies, as well as rare and orphan 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. 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.”
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. Vitae Pharmaceuticals believes inhibition of RORγt activity in Th17 cells will be beneficial for the treatment of multiple autoimmune disorders.
About VTP-43742
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.
About Vitae Pharmaceuticals
Vitae Pharmaceuticals is a clinical-stage biotechnology company focused on discovering and developing first-in-class, small molecule drugs for difficult-to-drug disease targets that can potentially address significant unmet medical needs, including disclosed programs in diabetes, Alzheimer’s disease, autoimmune disorders, atopic dermatitis and acute coronary syndrome. This robust and growing portfolio of novel product candidates is generated internally by Contour(R), Vitae’s proprietary structure-based drug discovery platform.
SOURCE: Vitae Pharmaceuticals
Post Views: 80
