Sofinnova-backed Abivax touts longer term mid-stage data in ulcerative colitis
Two months after Abivax convinced Sofinnova to bankroll several mid-stage studies of its lead drug — ABX464 — with a €12 million stock purchase, the Paris-based biotech has rolled out more data on the anti-inflammatory molecule for all investors to see.
In a Phase IIa maintenance study involving 22 patients with moderate to severe ulcerative colitis who have been failed by previous treatments, 12 achieved clinical remission as assessed by endoscopy. But since only 19 completed the full one-year trial, 16 of whom had an endoscopy, investigators scored the remission rate at 75%. Although there’s no comparator arm, execs were pleased with improvements over an initial two-month, placebo-controlled induction phase by a number of measures ranging from remission to Mayo score and a fecal biomarker.
“Our new data, presented as late breaker during the ‘IBD highlights session’ at UEG, exceeded our expectations regarding safety and efficacy during the 12-month maintenance study,” CMO Jean-Marc Steens said in a statement.
At the end of the original induction study, seven out of 19 patients achieved clinical remission — five of them were confirmed to be in remission after 10 more months, and the other two missed the endoscopy. Seven others went into remission during this period.
Other bright spots include the Mayo score, an index comprising stool frequency, rectal bleeding, endoscopic findings and physician’s global assessment. By Abivax’s count, the mean score fell from 8.7 to 1.9, translating to a dramatic -78% change. Median fecal calprotectin levels plunged from 1044 microg/g to 27.9 microg/g (-97%).
The data bode well for the ongoing Phase IIb in ulcerative colitis, Abivax added, as well as its other Phase IIa trials in rheumatoid arthritis and Crohn’s disease.
A once-daily oral drug, ABX464 is designed to upregulate an anti-inflammatory microRNA dubbed miRNA-124 by latching onto the cap-binding complex. That, in turn, chokes off certain cytokines and chemokines that cause certain inflammation, where the existing arsenal of immunomodulators, anti-TNFα, vedolizumab and corticosteroids don’t always work.
The therapy was also deemed a potential HIV breakthrough as it could theoretically prevent the replication of the virus. But that application didn’t particularly intrigue investors nor partners, pushing Abivax to focus on its anti-inflammatory uses with shrinking cash reserves.
Shares (EPA: $ABVX) jumped 14.30% to $9.35.
Social image: Microscopic image of biopsy obtained during colonoscopy from a patient with painful bloody diarrhea showing chronic ulcerative colitis, a type of inflammatory bowel disease (IBD), Shutterstock