Abivax’s stock has soared by more than 500% after its first-in-class ulcerative colitis (UC) therapy impressed in a Phase III trial.
The French biotech’s miRNA upregulator, obefazimod, showed an average 16.4% placebo-adjusted clinical remission rate across two Phase III trials after eight weeks in the high-dose cohorts.
After Abivax announced the Phase III UC success, the company’s stock price on the Nasdaq exchange soared by 586%, from a $10.00 close on 22 July to a $68.60 close on 23 July.
Abivax is also listed on the Paris exchange, where it also saw a 510% increase from a 22 July close of €8.90 ($10.46) to a 23 July close of €54.30 ($63.99).
Based on this data, investment firm Leerink Partners raised its price target on Abivax to $74 from $20, and Guggenheim increased its price target for Abivax to $101, maintaining a “buy” rating.
The ABTECT-1 (NCT05507203) and ABTECT-2 (NCT05507216) trials evaluated two doses of the therapy, 25mg and 50mg, in 1,275 patients with moderately to severely active UC who did not benefit from prior therapies.
In the ABTECT-1 study, there was an eight-week remission rate of 21.7%, and in ABTECT-2, the remission rate reached 19.8%.
The 25mg dose also showed statistical significance in ABTECT-1 with remission rates of 23.8%. This endpoint was not reached in the ABTECT-2 trial, with the 25mg dose achieving an 11.3% remission rate.
Clinical responses were 61% and 63.2% in the 50mg cohorts in the ABTECT-1 and ABTECT-2 studies, respectively. Other secondary endpoints, including endoscopic improvement and Histological Endoscopic Mucosal Improvement (HEMI), were met in the 50mg cohorts in both studies.
Obefazimod remained safe and tolerable in the trials, with a safety profile consistent with prior studies.
Abivax is continuing to evaluate obefazimod in a 44-week maintenance trial (NCT05535946) in UC. It is also being investigated in other indications, including Crohn’s disease, for which it is in a Phase IIb study.
Based on the two-Phase III trials and contingent on positive data from the maintenance study, Abivax hope to submit a new drug application (NDA) for obefazimod to the US Food and Drug Administration (FDA) and a marketing authorisation application (MAA) to the European Medicines Agency (EMA) in the second half of 2026.
UC market set to grow on new therapies
The most pressing unmet need in UC is a demand for more effective treatment options, as current therapies can struggle to achieve or maintain remission in patients. Current therapies can also cause immunosuppression, leading to severe treatment-emergent adverse events (TEAE), which result in the discontinuation of treatment in a significant number of patients.
GlobalData forecasts the UC market across the eight major markets (8MM: US, France, Germany, Italy, Spain, the UK, Japan, and Canada) will reach $10bn in 2031. This will be compounded by the approvals and launches of several new therapies, including Abivax’s obefazimod.
Clinical Trials Arena's parent company GlobalData anticipates sales of obefazimod to reach £1.66bn in 2031.
One of the therapies set to shape the UC market in the coming years is AbbVie’s Skyrizi (risankizumab), which received approval for use in UC by the FDA in June 2024.
Another is Johnson & Johnson and Protagonist’s icotrokinra for which GlobalData predicts a 2030 sales forecast of $2.19bn. Icotrokinra is also being investigated in other indications such as plaque psoriasis, for which the company is seeking FDA approval.
