Ulcerative Colitis Study Could Forecast Future Success of ABX464
The treatment also has potential in Crohn's disease and rheumatoid arthritis.
If ABX464 eventually gains US Food and Drug Administration (FDA) approval for patients with ulcerative colitis, it could spark future research testing the treatment for other indications, including Crohn’s disease, rheumatoid arthritis, and potentially others.
In fact, the treatment was once thought to be a potential medication for cancer.
Recently, there was data released showing the novel, orally administrated small molecule treatment resulted in 82.1% (n = 23) of patients who went into an ongoing, phase 3, maintenance trial in clinical remission remained in remission with the once-daily oral 50 mg treatment.
In addition, 49.3% (n = 36) of patients who were not in clinical remission at the end of the induction phase achieved a de novo clinical remission during the first year of maintenance.
In an interview with HCPLive®, Hartmut J. Ehrlich, MD, CEO of Abivax and Philippe Pouletty, MD, chairman of the board of directors at Abivax, said an ulcerative colitis approval from either the US or European regulatory bodies could yield future research in the other diseases mentioned.
“Clearly, when you show safety and efficacy in 1 disease like ulcerative colitis,” Ehrlich said. “From the mechanism of disease propagation, Crohn’s disease is very similar. In the end, for the regulators what is important is for every disease, you are showing the required efficacy and safety data.”
