Data from Abivax Trial Testing ABX464 Anti-inflammatory for UC Expected by Year’s End

Data from Abivax Trial Testing ABX464 Anti-inflammatory for UC Expected by Year’s End
Top-line data from an international Phase 2b clinical trial evaluating ABX464, Abivax’s lead therapeutic candidate for moderate-to-severe ulcerative colitis (UC), are expected later this year, according to the company’s financial report. In addition, Abivax confirmed its plans to initiate, in the second half of 2020, a similar Phase 2b trial assessing the potent anti-inflammatory therapy’s safety and effectiveness in people with Crohn’s disease (CD). “Abivax achieved several exciting clinical and regulatory milestones in 2019 and early 2020, making it a very successful year where we delivered on our long-term development strategy,” Hartmut Ehrlich, MD, CEO at Abivax, said in the report. “With the transformative potential of the efficacy results of ABX464 in ulcerative colitis, our lead product candidate made significant clinical progress and is now in mid-stage clinical testing in Europe and Canada, with patient recruitment allowed in the U.S. after a recently granted IND [investigational new drug application] from the FDA [U.S. Food and Drug Administration],” Ehrlich said. ABX464, initially developed as a potential treatment for HIV, is an oral small molecule designed to promote the production of miRNA-124, a microRNA molecule which was later found to have strong anti-inflammatory properties. MicroRNAs, or miRNAs, are small molecules that control genes’ activity by targeting their messenger RNA (mRNA) — the molecule that is used as a template for the production of proteins — and preventing them from making the protein they encode. Data from a previous Phase 2a clinical trial, called ABX464-101 (NCT03093259) and its open-label, one-year extension study (NCT03368118), known as ABX464-102, showed that daily treatment with 50 mg of A
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