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AVB 114

Drug Profile

AVB 114

Alternative Names: Autologous mesenchymal stromal cell coated fistula plug - Avobis Bio; AVB-114; MSC-AFP

Latest Information Update: 10 Mar 2025

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At a glance

  • Originator Mayo Clinic; W. L. Gore & Associates
  • Developer Avobis Bio; Mayo Clinic
  • Class Mesenchymal stem cell therapies
  • Mechanism of Action Cell replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Rectal fistula

Most Recent Events

  • 27 Feb 2025 AVB 114 receives Fast Track designation for Rectal fistula [Parenteral] (Treatment-experienced) in USA
  • 27 Feb 2025 AVB 114 receives IND clearance from the US FDA for Crohn's perianal fistulas in USA, prior to February 2025
  • 27 Feb 2025 Avobis Bio completes enrolment in a phase II trial in Rectal fistula (Treatment-experienced) in USA (Parenteral), prior to February 2025 (NCT04847739)

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