GAL-101 is a Phase 2/3-ready small molecule used to treat ophthalmic indications with high unmet medical need.
Théa Open Innovation (TOI), a sister company of ophthalmic specialty pharmaceutical company Laboratoires Théa, and Galimedix Therapeutics, Inc. announced they have signed a licensing agreement.
According to a press release from Galimedix, the company will grant TOI exclusive rights for the development and commercialization of GAL-101. In exchange, Galimedix will receive an upfront technology access fee and is eligible to receive further success-based milestone payments as well as royalties on net sales.
GAL-101 is a disease-modifying compound, for the topical and oral treatment of dry age-related macular degeneration (AMD), glaucoma and other ophthalmic indications and is ready to enter clinical Phase 2/3 trials, according to the release.
Delivered topically as an eye drop, it is expected to provide treatment for 2 of the leading causes of blindness – dry AMD and glaucoma. According to the company, this also includes normo-tension glaucoma, an indication not addressed by any of the approved glaucoma drugs. The company also states, GAL-101 was designed to target β-amyloid (Aβ) aggregates, the underlying cause of distinct neurodegenerative diseases of the eye and the central nervous system.
TOI will fully fund the remaining development of GAL-101 in dry AMD and take charge of the registration and commercialization of the drug, while Galimedix will remain responsible for the mid-stage clinical trials.
Jean-Frédéric Chibret, President of the Théa Group elaborated on the partnership In the release.
“Through the partnership with Galimedix, Thea will be among the few companies globally that are working on an innovative drug for the treatment of dry AMD patients who are currently at risk of going blind,” said Chibret. “We are excited to be working with Galimedix, as this collaboration supports our continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists around the world and their patients.”
According to the release, the first patient is planned to be enrolled in Phase 2 in 2024, with initial clinical efficacy results expected about 18 months later.
“We are excited to partner our front-runner program, GAL-101, in ophthalmology with TOI, a company highly respected in and fully dedicated to the challenging field of ophthalmology already for several generations. This collaboration is an important milestone for Galimedix, as it further validates our technology and is critical to bringing GAL-101 through clinical development and approval to help patients who are currently at risk of gradually going blind,” said Alexander Gebauer, MD, Executive Chairman of Galimedix in the release. “In addition, we are gratified by the strong support TOI has shown towards Galimedix by way of its equity investment in the company. This will enable us to move forward with our development plans for GAL-201, our next-generation oral compound for Alzheimer’s disease.”