Clinical stage biotech company Vitae Pharmaceuticals, Inc., recently announced the launch of a Phase I multiple ascending dose clinical study of VTP-43742, the company’s first-in-class RORγt inhibitor pipeline drug, indicated for the treatment of autoimmune diseases such as multiple sclerosis (MS) and several other orphan indications.
Preclinical studies of VTP-43742 exhibited the drug’s superior ability to inhibit IL-17 production from Th17 cells, which play key roles in driving inflammation while maintaining high selectivity compared to other ROR isotypes. The drug has a predicted human oral dosing schedule of once-a-day. Administration in animal models of multiple sclerosis yielded favorable results, compared to an IL-17A monoclonal antibody.
The company aims to conduct the study in two distinct patient populations. The first phase will seek to determine VTP-43742’s safety, tolerability, pharmacokinetic and pharmacodynamic profile in varying doses administered to healthy participants. The second part of the study will be a proof-of-concept trial wherein the company will evaluate the drug’s profile in patients diagnosed with psoriasis. Vitae expects to have top-line clinical efficacy results before the end of 2015. This study will be conducted with an ongoing Phase I single ascending dose study of the same drug, which began June 2015, for which the company expects to complete within the second half of 2015.
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