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A Phase 1/2 Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of AGTC-501 (rAAV2tYF-GRK1-RPGR) and a Phase 2 Randomized, Controlled, Masked, Multi-center Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Confirmed by a Pathogenic Variant in the RPGR Gene

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A Phase 1/2 Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of AGTC-501 (rAAV2tYF-GRK1-RPGR) and a Phase 2 Randomized, Controlled, Masked, Multi-center Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Confirmed by a Pathogenic Variant in the RPGR Gene

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Sep 2024

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At a glance

  • Drugs Laruparetigene zovaparvovec (Primary)
  • Indications Retinitis pigmentosa
  • Focus Adverse reactions
  • Acronyms HORIZON
  • Sponsors Applied Genetic Technologies Corporation; Beacon Therapeutics

    • Most Recent Events

    • 19 Sep 2024 According to Beacon Therapeutics media release, company presented 36-month interim results from its Phase I/2 HORIZON trial of its lead asset, AGTC-501, in patients with X-linked retinitis pigmentosa (XLRP) at the 24th EURETINA Congress held in Barcelona, Spain.
    • 19 Sep 2024 Results published in the Beacon Therapeutics Media Release.
    • 12 Jun 2024 According to Beacon Therapeutics media release, the company plans to use the data generated from the VISTA trial, in combination with data from the Phase 1/2 HORIZON and Phase 2 SKYLINE studies, including all available long-term data, to support a BLA in the US and a MAA in Europe for the treatment of patients with XLRP.

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