Théa Open Innovation and Galimedix announce strategic partnership to develop and commercialize GAL-101, a Phase 2/3-ready small molecule, 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. (“Galimedix”), a clinical-stage biotechnology company addressing the cause of neurodegenerative diseases of the eye and central nervous system, announced that they have signed a licensing agreement. Galimedix will grant TOI 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.

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 TOI 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, TOI will invest into Galimedix, thereby demonstrating its strong interest in the Galimedix pipeline, including in Alzheimer’s disease (AD).

“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 Jean-Frédéric Chibret, President of the Théa Group. “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: Eye drops and tablets – the first drug candidate for disease-modification of dry AMD is also designed to be patient friendly
GAL-101 is Galimedix’s most advanced compound, ready to enter clinical Phase 2/3 trials. Delivered topically as an eye drop, it is expected 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 demonstrated compelling efficacy, protecting neuronal retinal cells from toxic damage in relevant ophthalmic models.

In clinical Phase 1 testing, Galimedix has successfully demonstrated GAL-101’s excellent 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.

“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, Inc. “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.”

Age-related macular degeneration (AMD) – leading cause of adult blindness
AMD is a neurodegenerative disease of the retina and is classified as either “wet” or “dry”. Dry AMD is the most common form of the condition. In dry AMD, toxic Aβ aggregates cause retinal cells in the central area (the macula) to slowly degenerate and die. The result is progressive loss of vision. Currently, there is no approved treatment for dry AMD. AMD affects about one in four adults over the age of 65. It is estimated that there are currently around 200 million patients globally suffering from AMD, which is the leading cause of adult blindness in the U.S. and other industrialized countries.