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DB 001 - Direct Biologics

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Drug Profile

DB 001 - Direct Biologics

Alternative Names: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles - Direct Biologics; Exo Flo; ExoFlo

Latest Information Update: 09 Aug 2024

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At a glance

  • Originator Direct Biologics
  • Class Anti-inflammatories; Exosome therapies; Gene therapies; Immunotherapies
  • Mechanism of Action Immunosuppressants; Inflammation mediator modulators; Protein 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 III SARS-CoV-2 acute respiratory disease
  • Phase II COVID 2019 infections
  • Phase I/II Crohn's disease
  • Phase I Ulcerative colitis
  • Preclinical Inflammation; Joint disorders

Most Recent Events

  • 29 Jul 2024 Direct Biologics withdraws prior to enrollment a phase I/II trial for Adult respiratory distress syndrome (IV) due to change in development plan (NCT05127122)
  • 28 Aug 2023 Phase-I/II clinical trials in Crohn's disease (Treatment-experienced) in USA (IV) (NCT05836883)
  • 28 Apr 2023 Direct Biologics intends to pursue additional clinical applications in Crohn’s disease and Enterocolitis

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