EB 101 - Abeona Therapeutics

Drug Profile

EB 101 - Abeona Therapeutics

Alternative Names: Epidermolysis bullosa gene therapy - Abeona therapeutics; Gene-corrected skin grafts - Abeona Therapeutics; LEAES; LZRSE COL7A1; LZRSE-Col7A1 Engineered Autologous Epidermal Sheets

Latest Information Update: 01 Sep 2017

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At a glance

  • Originator Stanford University
  • Developer Abeona Therapeutics; Epidermolysis Bullosa Research Partnership; Stanford University
  • Class Gene therapies; Skin disorder therapies
  • Mechanism of Action Gene transference
  • Orphan Drug Status

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

    Yes - Epidermolysis bullosa
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Epidermolysis bullosa

Most Recent Events

  • 29 Aug 2017 EB 101 - Abeona Therapeutics receives Breakthrough Therapy status for Epidermolysis bullosa in USA
  • 18 Jul 2017 Abeona Therapeutics plans a phase III registrational study for Epidermolysis Bullosa in USA in early 2018
  • 30 May 2017 EB 101 receives Rare Pediatric Disease Designation from the US FDA for Epidermolysis bullosa
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