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
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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.

With over three years of experience in the medical communications business, Catarina holds a BSc. in Biomedical Sciences and a MSc. in Neurosciences. Apart from writing, she has been involved in patient-oriented translational and clinical research.
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With over three years of experience in the medical communications business, Catarina holds a BSc. in Biomedical Sciences and a MSc. in Neurosciences. Apart from writing, she has been involved in patient-oriented translational and clinical research.
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