Press release
MeiraGTx Reports First Quarter 2022 Financial and Operational Results
- Phase 3 Lumeos Clinical Trial of Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) Actively Dosing Patients-
About this update from Meiragtx Holdings Plc
[{"type":"text","content":"- Phase 3 Lumeos Clinical Trial of Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of X-linked Retinitis Pigmentosa (XLRP) Actively Dosing Patients- Phase 1 AQUAx Study of AAV-hAQP1 for Radiation-Induced Xerostomia Completed Dosing of Both Unilateral and Bilateral Cohorts in the First Quarter of 2022 LONDON and NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced financial results for the first quarter ended March 31, 2022 and provided an update on recent progress. “During the first quarter of this year, we continued to progress our lead program for the treatment of XLRP, botaretigene sparoparvovec, through pivotal development along with our partner Janssen,” said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx. “With the full operational and financial support of our partners at Janssen, this important program is proceeding as planned toward BLA submission in 2024.” Dr. Forbes continued, “As the biotech sector endures one of the most difficult periods in its history, we continue to recognize the strategic value of the end-to-end capabilities we have built at MeiraGTx over the past seven years. Our in-house manufacturing capabilities, from plasmid supply for GMP through GMP viral vector production and analytics for GMP stability and release, allow us to advance our wholly-owned and Janssen-partnered clinical and preclinical programs in a capital-efficient way without relying on third-party suppliers. For our lead program in XLRP, we are preparing for commercial supply including all QC and production activities internally. In addition to our manufacturing capabilities, MeiraGTx’s proprietary vector engineering and promoter platforms are enabling us to produce more potent vectors at lower doses, and our riboswitch technology provides us with an unprecedented control system for genetic medicines. These platform technologies give us potentially meaningful advantages in safety, efficacy and cost of goods across multiple programs.” Recent Development Highlights and Anticipated Milestones Botaretigene Sparoparvovec (AAV-RPGR) for the Treatment of XLRP: MeiraGTx and development partner Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, continu...