AVB-114 / Avobis Bio - LARVOL DELTA

AVB-114 Demonstrates Clinical Benefit in Persistent Crohn's Perianal Fistulas: Results From the Multicenter Randomized STOMP2 Trial (Late-Breaking Abstract) (ACG 2025) - "Subjects at 14 U.S. sites were equally randomized to SoC (N=24) or AVB-114 (N=24) (Table 1). At 9 mo, combined remission was 8.3% for SoC and 45.8% for AVB-114 (38% difference, 95% CI 11-60%; p=0.0078), with key secondary endpoints showing improvement with AVB-114 (Figure 1 and Table 2). In Part 1 through 9 mo, there were 40 and 56 treatment emergent adverse events (TEAE) for SoC and AVB-114, respectively."

Clinical • Late-breaking abstract • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Avobis Bio Presents Positive Primary Analysis Results from the Randomized Multicenter STOMP2 Clinical Trial at a Plenary Session of the American College of Gastroenterology's Annual Scientific Meeting (PRNewswire) - "To meet the effectiveness primary endpoint of Combined Remission at 9 months, there could be no collections >2cm in at least two of the three dimensions on the MRI (assessed by blinded core lab), the external opening must appear visually closed, and no drainage of fluid despite gentle finger compression. Combined remission was 8.3% (2/24) for SoC and 45.8% (11/24) for AVB-114 (38% difference, 95% confidence interval 11 – 60%, post hoc p-value = 0.0078).Additionally, AVB-114 showed a favorable safety and tolerability profile with no serious treatment-emergent adverse events through 9 months."

P2 data • Crohn's disease

FDA Grants RMAT Designation to Avobis Bio's Implantable Cell Therapy AVB-114 for Crohn's Perianal Fistulas (PRNewswire) - "Additionally, primary analysis of the follow-on randomized multicenter phase II trial ('STOMP-II') was recently completed. Results will be presented at the American College of Gastroenterology's 2025 Annual Scientific Meeting at Plenary Session 4B:IBD on Wednesday October 29, 2025 by Dr. David Schwartz..."

FDA event • P2 data • Crohn's disease

Avobis Bio Completes Primary Analysis of STOMP-II Randomized Clinical Trial of AVB-114 in Crohn’s Perianal Fistulas (PRNewswire) - "Avobis Bio LLC...announced today that primary analysis of the STOMP-II clinical trial led to a request to the U.S. Food and Drug Administration ('FDA') for Regenerative Medicine Advanced Therapy ('RMAT') designation for AVB-114, the Company's lead therapeutic candidate for Crohn's perianal fistulas. Avobis Bio completed the primary prospective analysis of the multicenter, randomized phase II trial ('STOMP-II') and subsequently filed a request for RMAT designation based on the results."

FDA event • P2 data • Crohn's disease

Avobis Bio Receives FDA Fast Track Designation for AVB-114 Implantable Cell Therapy for Crohn's Perianal Fistulas (PRNewswire) - "Avobis Bio LLC...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AVB-114, the Company's lead therapeutic candidate for Crohn's perianal fistulas....The Phase II clinical trial has completed enrollment at 14 US sites and subjects who were randomized to AVB-114 or standard of care are being assessed for combined clinical and radiological remission of the treated fistula."

Fast track • Crohn's disease

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Avobis Bio, LLC | Recruiting ➔ Active, not recruiting | Trial completion date: May 2026 ➔ Aug 2026 | Trial primary completion date: Dec 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

EAP-STOMP2: Expanded Access Protocol for STOMP-II Patients Who Were Unable to Receive Treatment Subsequent to Adipose Tissue Collection (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Avobis Bio, LLC

New trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Seeded Cells on Matrix Plug Treating Crohn's Perianal Fistulas (STOMP-II) (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Avobis Bio, LLC | Trial completion date: Jan 2025 ➔ May 2026 | Trial primary completion date: Aug 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease