France Is First EU Country to Give Abivax Go-ahead to Test ABX464 in Ulcerative Colitis

France Is First EU Country to Give Abivax Go-ahead to Test ABX464 in Ulcerative Colitis

France has become the first European country to give Abivax a green light to start clinical trials of ABX464 as a treatment for moderate-to-severe active ulcerative colitis.

The therapy candidate is already being tested against HIV/AIDS.

Belgium, Czech Republic, Germany, Hungary, Poland and Spain are expected to follow the French National Regulatory Authority in authorizing trials for ulcerative colitis.

ABX464, which is in Phase 2 clinical trials for patients with HIV/AIDS, blocks the replication of the human immunodeficiency virus. It also has anti-inflammatory qualities that help treat HIV/AIDS and that could be useful against ulcerative colitis, researchers say.

Abivax plans a Phase 2a trial (NCT03093259) to evaluate how the therapy candidate performs against moderate-to-severe active UC. The study, ABX464-101, will assess ABX464’s safety and effectiveness in 30 patients who are unable to tolerate, or failed to respond to, treatment with immunomodulators, anti-tumor necrosis factor alpha (TNFa), vedolizumab or corticosteroids.

Researchers will randomize patients to receive either 50 mg of ABX464 or a placebo once a day for eight weeks. They will look at whether the therapy can heal the damaged gastrointestinal tract lining of ulcerative colitis patients and whether it can put the condition into remission.

“Preclinical data published in Nature Scientific Reports show ABX464 dampened intestinal inflammation by triggering IL-22 production,” Hartmut J. Ehrlich, chief executive officer of Abivax, said in a press release. “As a result, we believe there is significant potential for the compound to be effective in patients with inflammatory bowel diseases (IBD). We are looking forward to initiating this study in the fourth quarter of 2017 and expect top-line data in the second half of 2018.”

“We are looking forward to the start of this study, as ulcerative colitis still carries a large unmet medical need,” added Dr. Severine Vermeire, a professor at University Hospitals Leuven in Belgium who is the principal investigator of the study. “Clinical research with new drug candidates is greatly needed to further improve treatments.”

“This first clinical study with ABX464 in ulcerative colitis is a critical step to demonstrate the clinical relevance of the anti-inflammatory proprieties of ABX464,” said Dr. Jean-Marc Steens, Abivax’s chief medical officer. “This demonstration may have clinical implications not only for patients with IBD, but also for patients with HIV who typically suffer from complications related to inflammation around the viral reservoirs.”

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