Vitalis is planning to open a pivotal clinical trial into its new formulation of fumarate, called VTS-72, that has shown promise in easing flushing — a common and troublesome side-effect of Tecfidera (dimethyl fumarate), an oral treatment for relapsing-remitting multiple sclerosis (RRMS).
The company announced plans to launch a pivotal study of VTS-72 in 2020, and use its data to help support a New Drug Application (NDA), requesting approval, which it plans to file with the U.S. Food and Drug Administration (FDA) later that year.
If approved, it hopes to market its lead treatment candidate sometime in 2021.
VTS-72 consists of a new formulation of fumarate combined with VTS-Aspirin, a Vitalis-owned platform based on aspirin. The therapy is being investigated as an alternative for RRMS patients who experience flushing as a side effect of Tecfidera treatment.
Flush is characterized by feelings of warmth and a rapid reddening of the skin, sometimes accompanied by spots or solid patches of redness, and is often painful. The intensity, frequency, and unpredictability of flush can be a burden on patients’ quality of life, and affect how well they comply with medications.
Tecfidera pills, whose active substance is fumaric acid or fumarate, is one of the most prescribed treatments for RRMS. Marketed by Biogen, it is known to effectively reduce MS flares and slow disease progression, but a downside is side effects associated with its use.
Along with gastrointestinal problems, flush is also commonly reported and estimated to affect 40% of the people taking Tecfidera.
Aspirin has long been used to reduce fumarate flush, but it only works if taken at least 30 minutes in advance — something patients can forget to do.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?