MeiraGTx Holdings, a clinical-stage genetic medicines company, has entered a broad strategic collaboration with Hologen Limited, a developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development.

Per the agreement, MeiraGTx will receive $200 million in upfront cash at closing, and MeiraGTx and Hologen are forming a joint venture, called Hologen Neuro AI Ltd. MeiraGTx will retain 30% ownership in the Hologen Neuro AI Ltd joint venture and will lead all clinical development and manufacturing. 

MeiraGTx and Hologen have created the first neuro-AI clinical drug development company in which technologies from both companies will be deployed to transform the discovery and development of therapies targeting CNS circuitry in neurodegenerative and neuropsychiatric disorders.

In addition to the $200 million upfront payment to MeiraGTx, 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 to treat Parkinson’s disease through to commercialization.

Funding will also go towards earlier-stage clinical programs in the CNS, including AAV-BDNF for genetic obesity. Hologen Neuro AI Ltd will use Hologen’s proprietary multi-modal generative foundation models (LMMs).

MeiraGTx will also enter into exclusive clinical and commercial manufacturing supply agreements with the joint venture. Also, 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 MeiraGTx’s manufacturing capabilities by utilizing MeiraGTx’s unique data lakes built over nine 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 an improvement of 18 points in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part 3 in the high dose group at 26 weeks, as well as 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 benefit on UPDRS Part 3, as well as other validated clinical endpoints.

The transaction is expected to close in the second calendar quarter of 2025, subject to customary closing conditions.