Press release
MeiraGTx Reports Fourth Quarter and Full Year 2022 Financial and Operational Results
- Announced positive clinical data from AQUAx AAV-hAQP1 Phase 1 trial for treatment of Grade 2/3 Radiation-Induced Xerostomia in December 2022 - Announced
About this update from Meiragtx Holdings Plc
[{"type":"text","content":"- Announced positive clinical data from AQUAx AAV-hAQP1 Phase 1 trial for treatment of Grade 2/3 Radiation-Induced Xerostomia in December 2022 - Announced positive top-line data from the MGT009 Phase 1/2 clinical study demonstrating safety and improvement in multiple domains of vision in X-linked retinitis pigmentosa (XLRP) patients treated with botaretigene sparoparvovec (AAV-RPGR) compared to untreated randomized control at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting - Continued enrollment and dosing of patients in pivotal Phase 3 Lumeos clinical trial of botaretigene sparoparvovec for the treatment of XLRP - On track for BLA submission of botaretigene sparoparvovec for the treatment of XLRP in 2024 LONDON and NEW YORK, March 14, 2023 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2022, and provided a corporate update. “As we begin 2023, we are increasingly confident in all three of our lead clinical programs, as well as our transformative riboswitch gene regulation technology,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “In the fourth quarter of last year, we announced positive clinical data from our Phase 1 trial of AAV-hAQP1 for the treatment of grade 2/3 radiation-induced xerostomia and presented positive data at AAO demonstrating positive safety and sustained vision improvement in patients with X-linked retinitis pigmentosa who were treated with botaretigene sparoparvovec in our Phase 1/2 trial. We also presented 15 abstracts at the European Society of Gene and Cell Therapy (ESGCT) Annual Congress highlighting just some of the data from our gene control platforms, including for the first time our riboswitch gene regulation applied to cell therapy. In addition, we began dosing patients with adeno-associated virus (AAV) encoding glutamic acid decarboxylase (AAV-GAD), an investigational gene therapy for Parkinson’s disease.” Dr. Forbes continued, “This year, in XLRP, we intend to complete enrollment of the pivotal Lumeos Phase 3 study and are on track for a BLA filing in 2024. In xerostomia, we intend to begin a randomized, double-blind, placebo-controlled, Phase 2 study in the second quarte...