FORT WASHINGTON, PA, USA I August 10, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced that it has initiated a Phase 1 multiple ascending dose clinical trial of VTP-43742, its wholly owned and first-in-class RORγt inhibitor product candidate for the treatment of autoimmune disorders, including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications.
Vitae plans to conduct this multiple ascending dose clinical trial in two populations. In the first part of the trial, the Company will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple ascending doses of VTP-43742 in healthy human volunteers. In the second, proof-of-concept portion of the trial, Vitae will assess the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical efficacy profile of multiple ascending doses of VTP-43742 in psoriatic patients, with top-line clinical efficacy results from those patients expected by the end of 2015. This trial coincides with an ongoing Phase 1 single ascending dose study of VTP-43742, which Vitae initiated in June 2015 and for which results are expected in the second half of 2015.
“The initiation of this second Phase 1 study of Vitae’s RORγt inhibitor marks significant progress for this exciting first-in-class product candidate,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “Our team looks forward to examining whether VTP-43742 can provide a safe and effective oral treatment option for a broad range of patients with serious autoimmune conditions.”
About Autoimmune Disorders
Autoimmune disorders, where the immune system attacks normal tissue, make up a large number of human disorders including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications. 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 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’s 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 has demonstrated superior efficacy in an animal model of multiple sclerosis in direct comparison to an IL-17A monoclonal antibody. Vitae previously initiated a Phase 1 single ascending dose clinical trial in healthy human volunteers in June 2015.
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: 97
FORT WASHINGTON, PA, USA I August 10, 2015 I Vitae Pharmaceuticals, Inc. (VTAE), a clinical-stage biotechnology company, today announced that it has initiated a Phase 1 multiple ascending dose clinical trial of VTP-43742, its wholly owned and first-in-class RORγt inhibitor product candidate for the treatment of autoimmune disorders, including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications.
Vitae plans to conduct this multiple ascending dose clinical trial in two populations. In the first part of the trial, the Company will evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of multiple ascending doses of VTP-43742 in healthy human volunteers. In the second, proof-of-concept portion of the trial, Vitae will assess the safety, tolerability, pharmacokinetic, pharmacodynamic and clinical efficacy profile of multiple ascending doses of VTP-43742 in psoriatic patients, with top-line clinical efficacy results from those patients expected by the end of 2015. This trial coincides with an ongoing Phase 1 single ascending dose study of VTP-43742, which Vitae initiated in June 2015 and for which results are expected in the second half of 2015.
“The initiation of this second Phase 1 study of Vitae’s RORγt inhibitor marks significant progress for this exciting first-in-class product candidate,” said Dr. Richard Gregg, Chief Scientific Officer of Vitae. “Our team looks forward to examining whether VTP-43742 can provide a safe and effective oral treatment option for a broad range of patients with serious autoimmune conditions.”
About Autoimmune Disorders
Autoimmune disorders, where the immune system attacks normal tissue, make up a large number of human disorders including psoriasis, psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis and multiple sclerosis, as well as numerous orphan indications. 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 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’s 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 has demonstrated superior efficacy in an animal model of multiple sclerosis in direct comparison to an IL-17A monoclonal antibody. Vitae previously initiated a Phase 1 single ascending dose clinical trial in healthy human volunteers in June 2015.
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: 97
