Galimedix Therapeutics announced it has reached a milestone in its collaboration with Théa Open Innovation (TOI), a subsidiary of ophthalmic pharmaceutical company Laboratoires Théa.

The milestone follows the successful completion of a phase 1 clinical trial of orally administered GAL-101, triggering an undisclosed milestone payment to Galimedix under the companies’ strategic partnership. Meanwhile, the eye drop formulation of GAL-101 is currently in phase 2 development for the treatment of geographic atrophy (GA).

“We are pleased with the achievement of this milestone for GAL-101,” said Céline Olmiere, Director of Théa Open Innovation. “This highly innovative drug candidate has the potential to significantly impact dry AMD patients who are at risk of going blind. Our collaboration with Galimedix supports continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists and their patients around the world.”

According to Galimedix, the phase 1 trial demonstrated that oral GAL-101 was well tolerated and clinically safe, with a favorable pharmacokinetic profile. The study also showed that the compound effectively crossed the blood–brain barrier, supporting plans to advance the oral formulation into phase 2 development for Alzheimer’s disease and other potential indications.

“We are gratified to have the strong support of Théa Open Innovation in developing GAL-101 and excited to see such solid results in the phase 1 trial,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman of Galimedix Therapeutics. “Importantly, this milestone payment provides Galimedix with significant operational runway and will allow us to advance our development plans for GAL-101 in Alzheimer’s disease and other supportive R&D work.”

Galimedix and TOI entered into a strategic partnership in March 2023 focused on the development and commercialization of GAL-101 in ophthalmology across Europe, the Americas, the Middle East, and Africa. Under the agreement, Galimedix received an upfront technology access fee and remains eligible for additional success-based milestone payments and royalties on net sales. TOI is funding the remaining development of GAL-101 for dry AMD and will oversee regulatory registration and commercialization in ophthalmology markets.

Galimedix remains responsible for conducting mid-stage clinical trials. TOI also made a direct investment in Galimedix, signaling confidence in the company’s broader pipeline, including programs targeting Alzheimer’s disease.

About GAL-101

GAL-101 is a small-molecule therapy designed to target misfolded amyloid beta (Aβ) monomers, preventing the formation of toxic Aβ oligomers and protofibrils believed to contribute to neurodegenerative diseases of the brain and retina.

The therapy is being developed in both oral and topical (eye drop) formulations and is initially being studied for dry AMD, glaucoma, and Alzheimer’s disease.

Preclinical studies have shown GAL-101 can prevent and eliminate toxic Aβ species while leaving healthy forms intact. The compound has also demonstrated neuroprotective potential and symptomatic benefits in Alzheimer’s disease models, along with low systemic toxicity, strong stability, and relatively simple manufacturing.

In ophthalmic preclinical models, GAL-101 has shown the ability to protect retinal neurons from toxic damage. Early clinical testing indicated both oral and eye drop formulations have favorable safety and tolerability profiles. The eDREAM Phase 2 clinical trial (NCT06659549) is currently evaluating GAL-101 eye drops for patients with dry AMD and geographic atrophy.