MeiraGTx (MGTX) Announces Data from Ongoing Clinical Trial of AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa to be Presented at EURETINA

September 22, 2020 8:32 AM EDT

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MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced nine-month results from the ongoing Phase 1/2 clinical trial (NCT03252847) of AAV-RPGR, an investigational gene therapy for the treatment of X-linked retinitis pigmentosa (XLRP), will be presented in an oral session at the EURETINA 2020 Virtual Meeting taking place October 2-4, 2020.

Details of the presentation are listed below. Data is embargoed until the date and time of presentation.

Title: Phase 1/2 Clinical Trial of AAV-RPGR Gene Therapy for RPGR-Associated X-Linked Retinitis Pigmentosa: 9-month Results
Presenter: Michel Michaelides, BSc MB BS MD(Res) FRCOphth FACS
Date and Time: Saturday, October 3, 10:45am EDT (4:45pm CEST)
Session: EURETINA Session 11: Late Breaking & Reviews

MeiraGTx and Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, are jointly developing AAV-RPGR as part of a broader collaboration to develop and commercialize gene therapies for the treatment of inherited retinal diseases.

In July 2020, MeiraGTx announced six-month data from the ongoing Phase 1/2 MGT009 clinical trial, which demonstrated AAV-RPGR was generally well tolerated and produced significant improvement in vision in the dose escalation phase of the trial.

AAV-RPGR is an investigational gene therapy for the treatment of patients with X-Linked Retinitis Pigmentosa (XLRP) caused by mutations in the eye specific form of the RPGR gene (RPGR ORF15). AAV-RPGR is designed to deliver functional copies of the RPGR gene to the subretinal space in order to improve and preserve visual function. MeiraGTx and development partner Janssen are currently conducting a Phase 1/2 clinical trial of AAV-RPGR in patients with XLRP with mutations in RPGR ORF15. AAV-RPGR has been granted Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and PRIME, ATMP and Orphan designations by the European Medicines Agency (EMA).

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