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.
“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.”
For additional information, please visit the company’s website at www.vitaepharma.com.
In other recent MS-related heath news, most people know that eating too much salt is bad for your health, but a new study suggests that it could also increase the risk for multiple sclerosis (MS). The work appeared in the August 2015 issue of The FASEB Journal, the journal of the Federation of American Societies for Experimental Biology. Researchers from the University of Vermont in Burlington found that mice who ingested too much sodium had more severe forms of experimentally-induced MS. While the effect seemed to depend on both genetics and gender, the findings could add salt to the other factors that have been proposed as contributors to the disease, such as environmental toxins and genes.