SeaBeLife enters deal with Unither to develop SBL03

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. Financial terms were not disclosed.