Avobis Bio will present expanded primary analysis results from the randomized multicenter STOMP2 Phase 2 clinical trial of AVB-114 at the European Crohn's and Colitis Organisation (ECCO) Congress.
The expanded analysis includes the original randomized AVB-114 cohort plus control arm subjects treated with AVB-114 after the primary endpoint, nearly doubling the sample size, with both cohorts showing comparable effectiveness and favorable safety through 9 months.234
Presentation by Dr. David A. Schwartz, who noted greater confidence in AVB-114's safety and efficacy for Crohn's perianal fistulas.34
Primary endpoint (Combined Remission at 9 months) met:
45.8% for AVB-114 vs. 8.3% for standard of care (p=0.0078).1
Avobis Bio reviewed updated data with FDA in a face-to-face meeting to expedite development, supporting Phase 3 trial preparations and fundraising.234
STOMP2 is a Phase 2 study in patients with refractory Crohn's perianal fistulas, randomized 1:
1 to AVB-114 or standard of care (fistula debridement and seton).13
Sources:
1. https://www.biospace.com/press-releases/avobis-bio-presents-positive-primary-analysis-results-from-the-randomized-multicenter-stomp2-clinical-trial-at-a-plenary-session-of-the-american-college-of-gastroenterologys-annual-scientific-meeting
2. https://www.pharmaindustrial-india.com/news/avobis-bio-to-present-expanded-stomp2-trial-data-on-avb-114-at-ecco-congress
3. https://www.prnewswire.com/news-releases/avobis-bio-announces-expanded-primary-analysis-results-from-the-randomized-multicenter-stomp2-clinical-trial-to-be-presented-at-european-crohns-and-colitis-organisation-ecco-congress-302673821.html
4. https://www.morningstar.com/news/pr-newswire/20260129ne73705/avobis-bio-announces-expanded-primary-analysis-results-from-the-randomized-multicenter-stomp2-clinical-trial-to-be-presented-at-european-crohns-and-colitis-organisation-ecco-congress