SeaBeLife Partners with Unither Pharmaceuticals to Advance SBL03 Ophthalmic Formulation for Retinal Degenerative Disorders
Key Insights
SeaBeLife (search) and Unither Pharmaceuticals have formed a joint development agreement to accelerate the pharmaceutical and regulatory preclinical development of SBL03 (search), an investigational topical ophthalmic formulation targeting geographic atrophy (search) and dry age-related macular degeneration (search).
SBL03 (search) represents a first-in-class dual inhibitor of necroptosis (search) and ferroptosis (search) pathways that demonstrated significant protection of retinal structural and functional integrity in preclinical animal models of induced retinal degeneration.
The partnership covers development and industrial scale-up, manufacturing of preclinical and GMP batches, analytical development, and preparation of CMC applications for regulatory submission, with clinical trials scheduled to begin in 2027.
France-based biotechnology company SeaBeLife (search) has entered into a joint development agreement with Unither Pharmaceuticals to accelerate the development of SBL03 (search), an investigational topical ophthalmic formulation for treating retinal degenerative disorders (search) including geographic atrophy (search) (GA) and dry age-related macular degeneration (search) (AMD). The partnership aims to produce clinical and commercial batches of the formulation with clinical trials scheduled to begin in 2027.
Novel Dual-Pathway Targeting Approach
SBL03 (search) represents a first-in-class therapeutic approach that simultaneously targets two regulated cell death pathways: necroptosis (search) and ferroptosis (search). Unlike conventional treatments that focus on the complement pathway, SeaBeLife (search)'s small molecules are designed to block cellular necrosis and address major unmet medical needs in retinal degeneration.
"This collaboration with Unither represents a major milestone in bringing our first-in-class candidate targeting necroptosis (search) and ferroptosis (search) to maturity," said Morgane Rousselot, PhD, CEO and co-founder of SeaBeLife (search). "Together, we're building the clinical path for a program that could transform the way that severe retinal diseases are managed."
The asset functions as a dual inhibitor of regulated necrotic cell death, effectively infiltrating eye tissues and protecting the retina from degeneration. These forms of regulated necrosis can cause inflammation and oxidative stress, contributing to retinal disease progression.
Promising Preclinical Efficacy Data
SeaBeLife (search) reported positive in vivo findings in January 2025 from research evaluating SBL03 (search)'s efficacy in an animal model of induced retinal degeneration. The study involved repeated topical doses of SBL03 over several days, with therapeutic effects analyzed through functional and structural analysis.
Investigators found that SBL03 (search)-treated animal eyes showed significant protection of the structural and functional integrity of the retina compared to placebo. According to the company, "The various parameters examined were correlated and demonstrated that repeated topical ocular treatment with SBL03 has a protective effect against retinal degeneration compared with placebo."
Partnership Structure and Development Timeline
The joint development agreement covers multiple aspects of pharmaceutical development, including development and industrial scale-up of SBL03 (search), manufacturing of preclinical and Good Manufacturing Practices (GMP) batches, analytical development, and preparation of Chemistry, Manufacturing, and Controls (CMC) applications for regulatory submission to begin phase 1 clinical trials.
SeaBeLife (search) retains ownership of the drug candidate while Unither will be responsible for pharmaceutical development and manufacture of preclinical batches. The agreement establishes joint work on testing the formulation and process development to start immediately, along with a shared steering committee to monitor progress and collectively approve major milestones.
"Unither is very excited about launching this partnership with the French biotech SeaBeLife (search)," said Nathalie Masson, director of innovation and development at Unither. "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."
Potential Market Impact
The topical delivery approach of SBL03 (search) represents a significant advancement over current standard of care treatments. With intravitreal injections being the current standard for retinal degeneration treatment, SBL03's non-invasive topical delivery through eye drops offers a promising alternative therapy that could improve patient compliance and reduce treatment burden.
Unither Pharmaceuticals brings substantial manufacturing expertise as a leading pharmaceutical contract development and manufacturing organization (CDMO) specialized in sterile single doses. The company operates manufacturing facilities across France, the United States, Brazil, and China, with over 2,200 employees and revenue of €522 million in 2024.
SeaBeLife (search), founded in 2019 in Roscoff, France, has raised €9 million in capital and public financing since inception and won the national i-Nov Competition 2024. The company's innovative technology platform is protected by patents already issued in Europe and the United States, positioning it as a pioneer in targeting dual cell death pathways for therapeutic intervention.