Vidofludimus is a novel, orally administered small-molecule drug for the treatment of autoimmune disorders such as inflammatory bowel disease (IBD).
It has completed a positive exploratory Phase IIa ENTRANCE study in IBD. This trial demonstrated that vidofludimus has the potential to be used for remission maintenance and relieve patients from further flare-ups of the disease. The recently completed Phase IIb COMPONENT study in rheumatoid arthritis did not meet its primary endpoint. However, various preclinical models demonstrate the potential application options of vidofludimus in further autoimmune indications.
The therapeutic effect of vidofludimus is based on a dual mechanism:
Vidofludimus inhibits the dihydroorotate dehydrogenase enzyme (DHODH), which, in its capacity as a key pyrimidine biosynthesis enzyme, supplies rapidly proliferating cells with essential DNA building blocks. The inhibition of DHODH reduces the division of activated T and B cells, which are much higher in inflamed tissues. Preclinical studies have also shown that vidofludimus suppresses the expression of selected inflammatory cytokines such as Il-17 (A&F) and INF-Gamma.For example, IL-17 is a signaling molecule that controls and regulates the inflammatory processes and is linked to numerous autoimmune diseases where the immune response is out of control. The combination of these modes of action provides an innovative therapeutic approach with a broad potential for clinical application in a variety of autoimmune diseases.
Some of the currently available therapies for IBD display severe side-effects or are not orally available, which can cause additional discomfort for patients with chronic diseases that require long-term treatment. Vidofludimus is intended to provide an innovative treatment option that is more tolerable and efficacious than existing therapies and can provide a better quality of life to patients.