– Outcomes in new cohort are favorable and consistent to previously reported randomized cohort for Crohn’s Perianal Fistulas –
NEWARK, Del., Jan. 29, 2026 /PRNewswire/ — Avobis Bio LLC, a clinical stage company developing implantable cell therapies, announced that expanded primary analysis results from the STOMP2 trial were just e-published in advance of an oral presentation at the upcoming European Crohn’s and Colitis Organisation (ECCO) Congress. Dr David A Schwartz, a STOMP2 investigator, Professor of Medicine in the Division of Gastroenterology, Hepatology and Nutrition, and Department of Medicine, and Director of the Inflammatory Bowel Disease Center at Vanderbilt University Medical Center, will present the results in Session A5 on Thursday, February 19th at 6:27PM local time.
Dr Schwartz previously presented STOMP2 primary endpoint results of subjects randomized to AVB-114 treatment. His ECCO presentation will include results of subjects randomized to control treatment who were subsequently treated with AVB-114 after their primary endpoint visit. Both AVB-114 cohorts demonstrated similar effectiveness through 9 months with favorable safety and tolerability.
Dr Schwartz commented that “I am eager to present this expanded STOMP2 analysis at ECCO. The all-treated AVB-114 sample size is nearly double that of the randomized set, providing greater confidence in AVB-114’s safety and efficacy profile in this severe complication of Crohn’s disease.”
Avobis reviewed the latest data with the U.S. Food and Drug Administration (“FDA”) via a face-to-face meeting focused on expediting its development plan. Tiffany Brown, PhD, Chief Executive Officer of Avobis Bio stated “These latest trial results, along with FDA’s recent in-person guidance, support our ongoing fundraising activities and phase 3 trial preparation. We continue to advance towards the ultimate goal of offering an effective treatment for the many patients suffering with this severe and debilitating manifestation of Crohn’s disease.”
About Crohn’s Perianal Fistulas
Perianal fistulas are painful tunneling wounds connecting the rectum or anus to the skin. The condition is serious as there is uncontrolled fecal drainage, pain and the constant risk of infection or sepsis. An estimated 2 out of 3 patients do not experience durable fistula healing with the current standard of care, resulting in elevated and prolonged suffering due to disease progression and multiple surgeries with complications.
About AVB-114
AVB-114 is the only clinical-stage implantable cell therapy aiming to overcome the impaired healing of Crohn’s perianal fistulas. Living cells and a plug-shaped bioabsorbable material combine to generate tissue and produce healing signals in a local therapeutic treatment.
FDA recently granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for AVB-114, which provides numerous benefits including intensive FDA guidance, senior management support, and clinical trial design flexibility to thereby expedite development to address this serious unmet need.
AVB-114 is an investigational drug and limited by United States law to investigational use. Its safety and effectiveness has not been established, and it is not commercially available in any markets.
About STOMP2
STOMP2 is a prospective, multicenter, randomized, wait-list controlled (WLC), open-label with a blinded outcome assessment, add-on therapy phase 2 study. Key eligibility criteria were a single perianal fistula tract (single internal and external opening) with prior failed treatment to biologic or conventional Crohn’s therapy or had documented medication intolerance.
The study consisted of two parts: Part 1 of the study included screening, enrollment, run-in, randomization, treatment, and follow-up through the primary endpoint analysis visit (Week 36), with additional follow-up at Weeks 52 and 104. Subjects were randomized 1:1 to treatment with standard of care (SoC) or investigational product (AVB-114). SoC consisted of fistula debridement and seton placement.
Part 2 of the study was only applicable to wait-listed control arm subjects following the Part 1 Week 36 study visit in which they could be treated with AVB-114, if desired by the subject and deemed appropriate by treating investigator. Control arm subjects that received AVB-114 treatment in Part 2 were followed for an additional 52 weeks post-AVB-114 treatment. To ensure subject safety, study validity and scientific merit a blinded core lab analyzed MRIs and an independent data safety monitoring board performed trial oversight.
For further study information please go to ClinicalTrials.gov.
About Avobis Bio
Avobis Bio’s mission is to transform life for patients with debilitating conditions by harnessing the power of implantable biology to develop curative therapies for healing tissues. For more information, please visit avobisbio.com.
Avobis Bio Media Contact:
Tiffany Brown, PhD
Chief Executive Officer
[email protected]
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SOURCE Avobis Bio
