What is Flush?
Two of Vitalis’ initial development programs focus on reducing flush in patients taking fumarates for multiple sclerosis and niacin for dyslipidemia.
Flush is characterized by feelings of warmth and rapid reddening of the skin, including the neck, upper chest, or face; blotchiness or solid patches of redness are often visible (Dunbar et al).
Flush can be extremely painful. It is associated with medications that activate the GPR109A receptor, also known as the Niacin Receptor, including nicotinic acids and fumaric acids (Hanson et al).
The intensity, frequency, and unpredictability of the flush can result in profound effects on the quality of life of patients. Many patients have described how severe flush can feel and look, describing it as "uncomfortable and embarrassing" or "feeling like I was on fire." Experiencing flush may mean that patients who require treatment for serious medical conditions may not take their medications as often as they should or suffer when they do (Sejbaek et al).
Flush is a highly prevalent side effect of fumarate therapy, experienced by approximately 40% of patients. The effects of flush are not only physical, but psychological as well, in that it impacts a patient’s appearance. In severe cases, it can cause extreme anxiety over being in social settings. For patients, it is a side effect that impacts quality of life seriously enough to result in therapy discontinuation.
VTS-72: A Novel, Low-flush Fumarate
VTS-Aspirin, when co-administered with potentially life-changing medications such as fumarates, has the potential to significantly reduce flush.
In a randomized, open-label, 2-way crossover comparative bioavailability study of 18 healthy subjects using the Global Flush Severity Scale (GFSS), VTS-72 lowered flush intensity by an average of 63.3% (p=0.0018) and eliminated flush in 39% of the patients who experienced flush with standard dimethyl fumarate.