SeaBeLife has announced that it has signed a joint development agreement with Unither Pharmaceuticals, a French pharmaceutical CDMO with an international footprint, specialised in the development and manufacture of sterile single doses.
The agreement will lead to the production of clinical and commercial batches of the topical ophthalmic formulation of the SBL03 drug candidate.
SBL03 is intended to treat degenerative disorders of the retina, such as geographic atrophy and dry age-related macular degeneration (AMD).
The partnership aims to speed up pharmaceutical and regulatory preclinical development prior to the launch of clinical trials, scheduled for 2027.
It covers the development and industrial scale-up of the formulation, the manufacture of preclinical and GMP batches, analytical development and preparation of the Chemistry, Manufacturing and Controls (CMC) application for submission to the relevant regulatory authorities to start Phase I clinical trials.
SeaBeLife retains ownership of its drug candidate, while the agreement entrusts Unither with the pharmaceutical development and manufacture of preclinical batches, thereby combining SeaBeLife’s scientific expertise with Unither’s pharmaceutical knowledge.
"This collaboration with Unither represents a major milestone in bringing our first-in-class candidate targeting necroptosis and ferroptosis to maturity," said Dr Morgane Rousselot, CEO and co-founder of SeaBeLife.
"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."
"Together, we’re building the clinical path for a programme 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."
The agreement provides for joint work on testing the formulation and process development to start immediately, as well as the setup of a shared steering committee to monitor progress and collectively approve major milestones.
SeaBeLife is developing a platform for innovative small molecules that can simultaneously target two major programmed cell death pathways, necroptosis and ferroptosis, to meet key medical needs with no therapeutic alternative in acute, rare or chronic indications.
At the start of 2025, SeaBeLife delivered promising preclinical efficacy results for SBL03 in geographic atrophy, a severe form of dry AMD.
"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 several 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."