Obefazimod bests placebo, improves ulcerative colitis in phase 2b induction trial
Click Here to Manage Email Alerts
Obefazimod improved moderate to severe ulcerative colitis compared with placebo in patients with documented nonresponse or intolerance to previous treatment, according to new data published in The Lancet Gastroenterology & Hepatology.
“This validates the safety and efficacy data generated with obefazimod in the initial phase 2a study in patients suffering from ulcerative colitis, including in a patient population refractory to biologics and/or JAK inhibitor treatments,” Severine Vermeire, MD, PhD, head of the IBD Center at University Hospitals Leuven in Belgium, said in a related press release. “I am impatient to start the global phase 3 program in UC and confident that we can confirm the rapid onset of action and maintained efficacy of obefazimod along with its good safety profile.”
In a phase 2b, double-blind, placebo-controlled trial, Vermeire and colleagues assessed the safety and efficacy of ABX464 (obefazimod, Abivax) compared with placebo in 254 patients with moderate to severe, active UC. Participants, who had a modified Mayo Score (MMS) of five points or higher and a history of nonresponse or intolerance to conventional therapy or biologics, were recruited from 95 hospitals and health care centers in 16 countries, including the United States.
Patients were randomly assigned to receive once daily oral ABX464 100 mg (n = 64), ABX464 50 mg (n = 63), ABX464 25 mg (n = 63) or placebo (n = 64). Two patients were excluded from analysis in the ABX464 25 mg group. The primary endpoint was change from baseline to week 8 in MMS, which consisted of a three-item questionnaire assessing stool frequency, rectal bleeding and flexible sigmoidoscopic examination.
According to study results, the least squares mean (LSM) change in MMS from baseline was –2.9 (95% CI, –3.4 to –2.5) for patients in the 100 mg group, –3.2 (95% CI, –3.7 to –2.7) for the 50 mg group, –3.1 (95% CI, –3.6 to –2.6) for the 25 mg group and –1.9 (95% CI, –2.4 to –1.5) for the placebo group.
Researchers reported a significantly greater difference in MMS from baseline among patients in all ABX464 groups compared with placebo (LSM difference from placebo: –1 for the 100 mg group, –1.3 for the 50 mg group and –1.2 for the 25 mg group).
Headache (42%, 30%, 21% and 8%, respectively) and nausea (14%, 6%, 8% and 6%) were the most frequently reported adverse events, and severe treatment-emergent adverse events were reported in 9%, 8%, 5% and 5% of patients. No deaths occurred during the study.
According to researchers, the safety and efficacy of ABX464 should be further evaluated in phase 3 clinical studies.
“The data generated so far with obefazimod in the phase 2a and phase 2b induction and maintenance studies gives reason to believe that this drug candidate may change the treatment paradigm for bio-naïve as well as refractory ulcerative colitis patients,” Bruce E. Sands, MD, MS, chief of the Dr. Henry D. Janowitz division of gastroenterology at the Icahn School of Medicine at Mount Sinai, said in the press release. “The maintained efficacy signal and the good tolerability profile differentiate obefazimod from many other products on the market or in late-stage testing in UC. Further, it offers an easy once-daily oral administration.”
Reference:
- Abivax phase 2b study results of obefazimod (ABX464) in ulcerative colitis published in The Lancet Gastroenterology & Hepatology. https://abivax.gcs-web.com/news-releases/news-release-details/abivax-phase-2b-study-results-obefazimod-abx464-ulcerative. Published Sept. 6, 2022. Accessed Sept. 7, 2022.
Collapse
Read more about
Click Here to Manage Email Alerts