First Patient Enrolls in Phase 2 Trial of ABX464, Potential Ulcerative Colitis Treatment

First Patient Enrolls in Phase 2 Trial of ABX464, Potential Ulcerative Colitis Treatment

A first patient has been enrolled in a proof-of-concept clinical trial of ABX464 as a possible treatment for people with moderate-to-severe active ulcerative colitis, its developer, Abivax, announced in a press release.

The patient was enrolled at the University Hospitals Leuven, Belgium. The trial involves 17 other centers in seven European countries besides Belgium: France, Germany, Poland, Hungary, Czech Republic, Spain and Austria.

ABX464 was first developed to be an oral, first-in-class, small molecule that might lessen or eliminate the HIV viral reservoirs, with the potential to reduce for the long term the viral load of HIV-patients. It is being tested in ulcerative colitis because it has shown the possibility of being a strong anti-inflammatory agent.

“The opportunity to study ABX464 in inflammatory bowel disease (IBD) inflammation came from clinical and preclinical anti-inflammatory effects observed in our research on this drug-candidate for treatment of HIV infection, where the HIV reservoir is the source of chronic inflammation,” Jean-Marc Steens, chief medical officer at Abivax said in the release.

ABX464’s efficacy has already been demonstrated in studies using IBD models.

In lab-grown human immune cells, scientists reported higher-than-usual levels of a specific protein (interleukin 22) and small RNA molecule (miR124), known mediators of the body’s immune response. This finding further supports ABX464 anti-inflammatory properties, and its potential benefit to people with ulcerative colitis, an inflammation-based disease.

ABX464-101 (NCT03093259) is a Phase 2a proof-of-concept study focused on the safety and efficacy of a 50 mg dose given once daily, for eight weeks, to 30 people with moderate-to-severe active ulcerative colitis who have failed or are intolerant to immunomodulators, anti-TNFα, vedolizumab or corticosteroids. A comparator group will receive a placebo.

Study participants at its conclusion will be invited to enroll in a 12-month, open-label follow-up study.

The trial is recruiting about 30 patients; information is available by clicking on its identification number.

“We welcome the involvement of Abivax in this therapeutic area that still carries a tremendous unmet medical need. Well designed studies, looking at objective endpoints … are critical in order to identify new drugs that can further improve treatment options for our patients,” said  Séverine Vermeire, a professor with the department of gastroenterology at University Hospitals Leuven, and the study’s principal investigator.

Preliminary results are expected to be reported in late 2018.