Drugs / AVB-114
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT04847739 | Sep 2021 → May 2025 overdue | Crohn disease, anal fistula | Avobis Bio, LLC | Active not recruiting | Met primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT06509828 Background | — | perianal Crohn disease | Avobis Bio, LLC | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-10-03 | Avobis Bio, LLC | Regulatory Avobis Bio Receives FDA RMAT Desingation for AVB-114 avobisbio.com ↗
Avobis Bio LLC , a clinical stage company developing implantable cell therapies, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Regenerative Medicine Advanced Therapy (“RMAT”) designation for AVB-114, the Company’s lead therapeutic candidate for Crohn’s perianal fistulas. |
| 2025-08-07 | Avobis Bio, LLC | Results STOMP-II Primary Analysis Complete avobisbio.com ↗ |
| 2025-02-27 | Avobis Bio, LLC | Regulatory FDA Grants Fast Track Designation for AVB-114 avobisbio.com ↗
Avobis Bio LLC, a clinical stage company developing implantable cell therapies, 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. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-10-03 | Avobis Bio, LLC | Avobis Bio Receives FDA RMAT Desingation for AVB-114 avobisbio.com ↗ |
| 2025-08-07 | Avobis Bio, LLC | STOMP-II Primary Analysis Complete avobisbio.com ↗ |
| 2025-02-27 | Avobis Bio, LLC | FDA Grants Fast Track Designation for AVB-114 avobisbio.com ↗ |
| 2024-08-31 | Avobis Bio, LLC | Avobis Bio Announces Enrollment Completion of STOMP-II Phase 2 Clinical Trial of AVB-114 in Patients with Crohn’s Perianal Fistula avobisbio.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVB-114 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06509828 ↗ |
| Modality | Cell therapy | “implantable autologous cell therapy AVB-114” PMID 41879234 ↗ Mar 2026 |
| Route | Other | “AVB-114 will be inserted into the subject's fistula by a study doctor on Day 0.” NCT04847739 ↗ |