Two companies, one goal: speed SBL03 toward trials in diseases that need new answers.
SeaBeLife (Roscoff, France) has inked a joint development agreement with Unither Pharmaceuticals (Paris, France) to accelerate the ophthalmic formulation, scale-up and GMP manufacturing of SBL03, a topical drug candidate in development for degenerative retinal diseases, including geographic atrophy (GA) and dry age-related macular degeneration (AMD).
The partnership triggers immediate formulation and process development work and includes preparation of the Chemistry, Manufacturing and Controls (CMC) package, as well as support for producing both clinical and commercial batches.
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“This collaboration with Unither represents a major milestone in bringing our first-in-class candidate targeting necroptosis and ferroptosis to maturity,” said Dr. Margane Rousselot, CEO and co-founder of SeaBeLife, in a news release. “Their industrial expertise and international footprint mean that we’re going into CMC development with a strong, ambitious framework in place, to safeguard our clinical and regulatory development pathway and foster a robust route to scale-up.”
He added, “Together, we’re building the clinical path for a program that could transform the way that severe retinal diseases are managed. This perfectly illustrates what we’re aiming for in the ophthalmology market, to speed up the clinical development and availability of our therapy and to establish collaborations on our ophthalmic formulations incorporating SBL03.”
Phase I trials for SBL03 are slated for 2027. Under the agreement, SeaBeLife will retain ownership of the molecule while leaning on Unither’s long-standing expertise in sterile single-dose development and manufacturing.
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What is SBL03?
The drug is designed to target regulated cell-death pathways—necroptosis and ferroptosis—which SeaBeLife aims to inhibit simultaneously through its platform of small molecules. Both pathways are implicated in retinal degeneration.
Earlier this year, SeaBeLife reported promising preclinical efficacy data for SBL03 in GA, supporting the continued advancement of the ophthalmic formulation and reinforcing the rationale for moving into pharmaceutical and regulatory development ahead of first-in-human evaluation.
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A partnership focused on acceleration
Under the agreement, Unither will lead the technical and industrial work needed to bring the topical formulation to clinical readiness, including analytical development, formulation optimization, process refinement and manufacturing of both preclinical and GMP batches.
“Unither is very excited about launching this partnership with the French biotech SeaBeLife. It confirms our commitment to working with innovative companies in the field of ophthalmology. This partnership enables us to share the risks and the costs in developing drug candidates together, for a number of ophthalmic diseases for which few or no treatment options currently exist,” said Nathalie Masson, director of Innovation and Development at Unither. “This represents a key step in implementing our innovation strategy, which aims to foster more joint development collaborations.”
The partnership underscores both companies’ intent to push forward solutions for degenerative retinal disease, an area where unmet need still looms large. By pooling their strengths, they aim to chart a more streamlined path from early development to clinical evaluation.
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The takeaway
If all goes according to plan, SBL03 could take its first clinical step in 2027—a small but meaningful stride toward expanding options for retinal diseases that have long lacked them.
A little momentum can go a long way in a field hungry for breakthroughs.Editor’s Note: This content is intended exclusively for healthcare professionals. It is not intended for the general public. Products or therapies discussed may not be registered or approved in all jurisdictions, including Singapore.