French biotech company Abivax has revealed positive topline results from a Phase IIb study of its investigational oral drug candidate ABX464 in ulcerative colitis (UC) patients.
In the study, 254 patients with moderate-to-severe UC received treatment with ABX464, with topline data showing significant clinical efficacy in the overall population on both primary and key secondary endpoints.
Of these patients, 50% had inadequate response, loss of response or intolerance to tumour necrosis factor alpha (TNF-α) inhibitors, Takeda Entyvio (vedolizumab), other biologics and/or JAK inhibitor treatments, while the other half were refractory to conventional treatments.
Preliminary results from the open label maintenance study in the first 51 patients after 48 weeks of treatment with ABX464 demonstrated 53% in clinical remission and 59% with endoscopic improvement.
The treatment was also well tolerated and demonstrated a good safety profile, with an overall drop-out rate of patients in the study being 9%.
“The phase 2b results demonstrate the potential of ABX464 to become a gamechanger for the treatment of ulcerative colitis patients in need of new therapeutic management options,” said Hartmut Ehrlich, chief executive officer of Abivax.
“Interestingly, the lowest dose of 25mg was effective across the entire study population, including patients refractory to biologics and JAK inhibitors, with a safety profile that is very similar to the placebo group.
“Based on these data, we are now moving forward as quickly as possible with our Phase III plan in ulcerative colitis as well as Phase IIb/III in Crohn’s disease to bring ABX464 to the many patients suffering from inflammatory bowel disease,” he added.
Abivax is planning to submit the Phase IIb study results to a peer-reviewed journal, as well as at upcoming ‘major scientific conferences’.