– MeiraGTx to receive $200 million in upfront cash consideration
– MeiraGTx and Hologen will form a joint venture, Hologen Neuro AI Ltd, with an additional $230 million committed capital from Hologen to fund 100% of the development of AAV-GAD for Parkinson’s disease through to commercialization, as well as other potential pipeline products
– MeiraGTx will enter into clinical and commercial supply agreements with Hologen Neuro AI Ltd to manufacture AAV-GAD and other locally delivered CNS genetic medicines
– Hologen will also fund a portion of MeiraGTx’s manufacturing operations and will own a minority stake in MeiraGTx’s manufacturing subsidiary
LONDON and NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) — MeiraGTx Holdings plc (NASDAQ:MGTX), a vertically integrated, clinical stage genetic medicines company, today announced a broad strategic collaboration with Hologen Limited, a world-leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development.
MeiraGTx will receive $200 million in upfront cash at closing and MeiraGTx and Hologen are forming a joint venture, called Hologen Neuro AI Ltd. In addition to the $200 million upfront payment to MeiraGTx, the joint venture, Hologen Neuro AI Ltd, will be funded with committed capital of up to $230 million from Hologen to fully finance the development of AAV-GAD for the treatment of Parkinson’s disease through to commercialization, as well as funding earlier stage clinical programs in the CNS, including AAV-BDNF for genetic obesity. Hologen will contribute its proprietary multi-modal generative foundation models (LMMs) to the joint venture. In forming this joint venture, MeiraGTx and Hologen have created the first neuro-AI clinical drug development company in which pioneering technologies from both companies will be deployed to transform the discovery and development of therapies targeting CNS circuitry in neurodegenerative and neuropsychiatric disorders.
MeiraGTx will retain 30% ownership in the Hologen Neuro AI Ltd joint venture and will lead all clinical development and manufacturing. MeiraGTx will also enter into exclusive clinical and commercial manufacturing supply agreements with the joint venture. In addition, Hologen will own a minority stake in MeiraGTx’s manufacturing subsidiary and will contribute to the annual funding of the manufacturing subsidiary. Hologen is deploying its generative AI capabilities to further optimize MeiraGTx’s proprietary manufacturing capabilities by utilizing MeiraGTx’s unique data lakes built over 9 years of development of MeiraGTx’s manufacturing platform process.
MeiraGTx’s AAV-GAD program for Parkinson’s disease is Phase 3 ready with commercial manufacturing ongoing in-house at MeiraGTx. The Company reported positive data from its randomized, sham-controlled clinical bridging study of AAV-GAD in October 2024, showing significant improvement of 18 points in Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 in the high dose group at 26 weeks, as well as significant improvement in the Parkinson’s Disease Questionnaire (PDQ-39) score, a key quality of life measure, for both the high and low dose groups at 26 weeks. This is the second double blind sham-controlled study of AAV-GAD in Parkinson’s disease to show a statistically significant benefit on UPDRS Part 3, as well as other validated clinically meaningful endpoints.
Alexandria Forbes, Ph.D., co-founder, president and CEO of MeiraGTx stated, “We are delighted to be entering into this transformative collaboration with Hologen. Our initial focus is to increase the robustness, efficiency and probability of success of the AAV-GAD Phase 3 clinical study. The use of Hologen’s AI to elucidate brain circuitry in this complex heterogeneous disease has already significantly de-risked the AAV-GAD Phase 3 program when applied to MeiraGTx’s Phase 2 clinical data sets and has identified disease modifying changes in the physiology of the brain in response to AAV-GAD treatment.”
Dr. Forbes continued, “Our collaboration with Hologen has broad significance for MeiraGTx and for drug development for neurological disorders in general. Deploying Hologen’s LMMs on MeiraGTx’s clinical data allows …