Vitae Pharmaceuticals to Launch New Study of Therapy For MS, Other Autoimmune Disorders

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by Patricia Silva, PhD |

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Clinical stage biotech company Vitae Pharmaceuticals, Inc., recently announced the launch ofĀ a Phase I multiple ascending dose clinical study of VTP-43742, the company’s first-in-class RORĪ³t inhibitor pipeline drug, indicated for the treatment of autoimmune diseases such as multiple sclerosis (MS) and several other orphan indications.

Preclinical studies ofĀ 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 conductĀ the study in two distinct patient populations. The first phase will seekĀ to determineĀ 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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“The initiation of this second Phase 1 study of Vitae’s RORĪ³t 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 atĀ www.vitaepharma.com.

In other recent MS-related heath news,Ā most people know thatĀ eating too much saltĀ is bad for your health, but a new study suggests that it could also increase the risk forĀ multiple sclerosisĀ (MS).Ā The workĀ appearedĀ in the August 2015 issue ofĀ The FASEB Journal,Ā the journal of the FederationĀ of American SocietiesĀ forĀ Experimental Biology. Researchers from theĀ University of Vermont in Burlington found that mice who ingestedĀ too much sodium had more severe forms of experimentally-induced MS. While theĀ 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.