Press release
MeiraGTx Announces Data from Ongoing Clinical Trial of AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa to be Presented at AAO 2020 Virtual Meeting
12-Month Dose Escalation Data from Phase 1/2 Clinical Trial to be Presented LONDON and NEW YORK, Oct. 28, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc
About this update from Meiragtx Holdings Plc
[{"type":"text","content":"12-Month Dose Escalation Data from Phase 1/2 Clinical Trial to be Presented\nLONDON and NEW YORK, Oct. 28, 2020 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced that twelve-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 American Academy of Ophthalmology 2020 Virtual Meeting taking place November 13-15, 2020.\n Details of the presentation are listed below. Data is embargoed until the date and time of presentation. Title: Phase 1/2 Trial of AAV5-RPGR Gene Therapy for RPGR-Associated X-Linked Retinitis Pigmentosa (XLRP): 12-month ResultsPresenter: Michel Michaelides, BSc MB BS MD(Res) FRCOphth FACSDate and Time: Friday, November 13, 2:55pm PST (5:55pm EST)Session: Late Breaking Developments, Part I 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 and October 2020, MeiraGTx announced six-month and nine-month data, respectively, from the ongoing Phase 1/2 MGT009 clinical trial which demonstrated AAV-RPGR was generally well tolerated and produced significant improvement in vision, including improvement in retinal sensitivity and vision-guided mobility, in the dose escalation phase of the trial. About AAV-RPGRAAV-RPGR is an investigational gene therapy for the treatment of patients with X-linked retinitis pigmentosa (XLRP) caused by disease-causing variants 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 disease-causing variants 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). About the Phase 1/2 MGT009 Clinical Tria...