Théa Open Innovation and Galimedix Partner to Develop and Commercialize GAL-101 for Ophthalmic Indications
Théa Open Innovation and Galimedix Therapeutics announced that they have signed a licensing agreement in which Galimedix will grant Théa exclusive rights for the development and commercialization of GAL-101, Galimedix’s lead disease-modifying compound, for the topical and oral treatment of dry age-related macular degeneration (AMD), glaucoma, and other ophthalmic indications with high unmet medical need, in Europe, the Americas, the Middle East and Africa.
Financial terms of the deal were not disclosed.
Under the terms of the agreement, 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. While Théa will fully fund the remaining development of GAL-101 in dry AMD and take charge of the registration and commercialization of the drug, Galimedix will remain responsible for the mid-stage clinical trials, leveraging their respective expertise and familiarity with the compound, which has a unique first-to-market mechanism of action. Furthermore, Théa will invest in Galimedix.
“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,” Jean-Frédéric Chibret, President of the Théa Group, said in a company news release. “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.”
GAL-101 is Galimedix’s most advanced compound, ready to enter phase 2/3 trials. Delivered topically as an eye drop, it is designed to provide a convenient and safe treatment for two of the leading causes of blindness–dry AMD and glaucoma, including normo-tension glaucoma, an indication not addressed by any of the approved glaucoma drugs. 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 (CNS).
Preclinically, GAL-101 has demonstrated compelling efficacy, protecting neuronal retinal cells from toxic damage in relevant ophthalmic models, according to Galimedix.
In phase 1 testing, Galimedix successfully demonstrated GAL-101’s safety and tolerability profile. Also, the company has received supportive FDA feedback to continue the development through phase 2 or phase 2/3. The first patient is planned to be enrolled in 2024, with initial clinical efficacy results expected about 18 months later. Based on convincing results in animals, it is also planned to develop GAL-101 as an oral formulation to offer another convenient treatment alternative to patients, according to Galimedix.
“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 Therapeutics. “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.”