Théa Open Innovation (TOI) and Galimedix Therapeutics, Inc. announced a licensing agreement for the development and commercialization of GAL-101, Galimedex’s lead compound, for the topical and oral treatment of dry age-related macular degeneration (AMD), glaucoma, and other ophthalmic indications.
Under the agreement, Théa will be granted the exclusive rights to both develop and commercialize GAL-101.
Refresh me on both companies.
Galimedix Therapeutics is a clinical-stage biotechnology company focused on developing novel first-in-class drugs that stop or slow the progression of neurodegenerative disease as well as improve function in glaucoma, dry AMD, and Alzheimer’s disease,
Théa Open Innovation, a sister company of Laboratoires Théa, identifies, evaluates, and supports eyecare developments via establishing license agreements and/or capital investments with key strategic partners.
Now tell me about GAL-101.
GAL-101 is a novel, small molecule eye drop designed to provide neuroprotection and improved visual function for retinal diseases by targeting β-amyloid (Aβ) aggregates to slow the progression of blindness associated with neurodegenerative diseases like dry AMD and glaucoma.
Plans are also being made to develop GAL-101 in an oral formulation as a treatment alternative..
Any clinical data already on it?
Yes! GAL-101 demonstrated a favorable safety profile that was well-tolerated during a phase 1, randomized, double-masked, placebo-controlled, single center study that enrolled 70 patients (40 healthy; 30 with glaucoma).
The study’s protocol was accepted by the FDA to support the launch of larger clinical studies for glaucoma and dry AMD; a phase 2 or phase 2/3 study is planned to enroll the first patient in 2024, with initial clinical efficacy results released 18 months after.
Alright, tell me more about this agreement now.
Per the agreement terms, Galimedix will receive an upfront technology access fee and be eligible for further milestone payments (success-based) as well as net sales royalties. The company will also be responsible for the mid-stage clinical trials on GAL-101.
What about Théa’s role?
Along with the exclusive rights to develop and commercialize GAL-101, Théa will also fully fund the remaining development of GAL-101 in dry AMD, be responsible for the drug’s registration, and invest in Galimedix.
Financial details?
As of March 29, no information was disclosed.
Significance?
GAL-101 would be the first drug candidate for disease-modification of dry AMD in Europe, the Americas, the Middle East, and Africa.