Avobis Bio LLC, a clinical-stage biotechnology company focused on implantable cell therapies, has announced the e-publication of expanded primary analysis results from its STOMP2 clinical trial. The findings will be formally presented at the European Crohn’s and Colitis Organisation (ECCO) Congress.

Dr. David A. Schwartz, STOMP2 investigator and Professor of Medicine at Vanderbilt University Medical Centre, will present the data during Session A5 on February 19. In addition to previously shared primary endpoint results from patients randomised to receive AVB-114, the presentation will include new data from control-arm participants who later received AVB-114 after completing their primary endpoint visit.

According to the company, both AVB-114-treated cohorts demonstrated comparable effectiveness through nine months, along with favorable safety and tolerability outcomes.

Dr. Schwartz noted that the expanded analysis nearly doubles the all-treated AVB-114 sample size compared to the original randomised cohort, strengthening confidence in the therapy’s safety and efficacy profile for patients suffering from severe complications of Crohn’s disease.

Avobis Bio also confirmed it has reviewed the updated data with the US Food and Drug Administration (FDA) during a recent in-person meeting aimed at accelerating the development pathway.

Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio, stated that the latest results, combined with FDA guidance, support the company’s ongoing fundraising efforts and preparations for a Phase III trial. She added that the company remains focused on advancing AVB-114 toward becoming a potential treatment option for patients affected by severe and debilitating manifestations of Crohn’s disease.