The approval by the U.S. FDA in October of Pfizer Inc.’s Velsipity (etrasimod), an oral sphingosine-1-phosphate receptor modulator for moderately-to-severely active ulcerative colitis, brought renewed attention to the inflammatory bowel disease (IBD) landscape, where the hunt goes on for new alternatives. Among the promising soldiers in the march is Paris-based Abivax SA, which closed its IPO the same month.
Abivax SA’s debut on the U.S. market received a somewhat chilly reception Oct. 20, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8 million in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammatory bowel disease space.
For European biotech, the first quarter (Q1) of 2023 could hardly be described as the best of times – but the period did not represent the worst of times either. European firms engaged in drug discovery and development collectively raised $1.88 billion during this period. The tally is 4% less than the total raised in the comparable period last year, and it represents just 32% of the total raised during the COVID-19-fueled biotech boom during 2021. But it’s still the third highest Q1 raise during the last six years.
DUBLIN – Abivax SA has started planning for a pivotal phase III program for its inflammatory bowel disease drug candidate, ABX-464, following a readout of top-line data from a phase IIb induction study in ulcerative colitis, in which the molecule attained the primary endpoint at all three dose levels tested. It demonstrated efficacy on a range of secondary endpoints, too, while its safety profile also appeared to be favorable.
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.
DUBLIN – Abivax SA has rejected an acquisition offer in order to pursue a phase IIb/III trial of its lead anti-inflammatory drug ABX-464 in 1,034 COVID-19 patients.