DGAP-News

Abivax completes induction treatment of last patient in ABX464 phase 2b clinical study in ulcerative colitis - Seite 2

Sophie Biguenet, M.D., CMO of Abivax, said: "We are very much looking forward to communicating the results of the 16-weeks phase 2b induction study during the second half of May this year. These data will provide valuable information on the potential of ABX464 to become a well-tolerated, oral, easy-administrable, short- and long-term effective novel treatment option for the many patients suffering from moderate-to-severe UC. In parallel, the phase 2b maintenance study is continuing as planned and we are preparing for our phase 3 program in UC, expected to start by year end."

Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: "The clinical phase 2b top-line read-outs in UC next month will give us more visibility on the strategic options for the Company. We will carefully evaluate and select the most attractive path forward to create shareholder value. Partnering with a large pharma or biotech company remains our strategic priority."

The randomized, double-blind and placebo-controlled phase 2b induction trial had four arms: three once-daily oral ABX464 treatment groups (25 mg, 50 mg and 100 mg) and one placebo group. The study is conducted in 130 study centers in 15 European countries, Canada and the US under the leadership of its principal investigator, Prof. Séverine Vermeire, M.D., Ph.D., University Hospitals Leuven, Belgium. Prof. William Sandborn, M.D., University of California San Diego Health, serves as the principal investigator for the US.

All patients who completed the induction study had the option to enroll into the subsequent open-label maintenance study for up to two years to confirm the long-term safety and efficacy profile of ABX464. During this maintenance period, patients are being treated in an open label fashion with 50mg of once-daily oral ABX464. Abivax is using IQVIA as partner, a global premier CRO, to successfully conduct its clinical trials with ABX464 for the treatment of chronic inflammatory diseases.

At present, more than 800 patients have been treated with ABX464 across different indications, including UC. Some of these patients are in their fourth year of continuous daily dosing within the ongoing phase 2a maintenance study. Abivax reported excellent induction (after 8 weeks) as well as maintenance (after one and two-years) safety and efficacy data from the ABX464 UC phase 2a maintenance study with 50 mg once-daily oral ABX464 in patients with moderate-to-severe UC. After 12 months of treatment, 75% of the patients were in clinical remission. After the second year of continued treatment, 69% of patients were in clinical remission and 94% benefited from a clinical response.