ABIVAX: ABX464 shows excellent long-term efficacy data in Abivax's phase 2b maintenance Trial in ulcerative colitis - Seite 2

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: "We are very pleased with the confirmation of the long-term efficacy of ABX464 for the treatment of ulcerative colitis. This trend was already observed in the phase 2a proof-of-concept study, in which 50% of the patients (ITT) were still in clinical remission after 3 years of treatment. These impressive results are now further strengthened by the first 101 patients who completed the one-year maintenance in phase 2b. Importantly, most published maintenance studies with other drugs only allowed patients who already showed a clinical response in the short-term induction study to enter into maintenance, thereby overestimating their long-term efficacy rate. In contrast, all patients had the possibility to continue their treatment in the ABX464 maintenance study, irrespective if they had a clinical response or not at the end of induction, thereby giving a chance even to the most severe cases. We are committed to rapidly bringing ABX464 into phase 3 testing, as we want to make this potentially transformative drug-candidate available as quickly as possible to patients suffering from ulcerative colitis."

ABX464 phase 2b clinical maintenance study in ulcerative colitis - 101 patients completed 48 weeks

The new data from the phase 2b open-label extension study in UC, presented by Prof. Séverine Vermeire during the late-breaking abstract session at UEG Week Virtual 2021, included 101 patients who completed 48 weeks of chronic treatment with ABX464 as of September 15, 2021.

97.7% (217/222) of all patients who completed the phase 2b induction study, irrespective of treatments or treatment outcome during the induction phase, enrolled in the subsequent open-label maintenance study to evaluate the long-term safety and efficacy profile of ABX464 for up to two years.

All patients

Patients with clinical response ^[1] after induction

Patients without clinical response after induction

At week 48

PP ^[2] n=88

ITT ^[3] n=101

PP n=54

ITT n=63

PP n=34

ITT n=38

Clinical remission ^{[4] ,} *

n=59 (67%)

n=59 (58.4%)

n=40 (74%)

n=40 (63.5%)

n=19 (55.9%)

n=19 (50%)

* Drop-outs (13 patients) were considered as treatment failures in the ITT analysis.

Among the subset of 101 patients for whom 1 year maintenance data is currently available (cut-off date: September 15, 2021), 28 had entered the maintenance study already in clinical remission: 23/28 (82.1%) of these patients stayed in clinical remission and only 5/28 patients (17.9%) lost clinical remission during this first year of maintenance.