AVB-114 / Avobis Bio - LARVOL DELTA

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