SeaBeLife has secured €2.9 million in French government funding to advance SBL01, an experimental drug candidate for acute liver injury, towards clinical trials.

The funding will support the SeaBeLIVER project, a €6.47 million programme backed through France 2030, the French government’s investment plan, and administered by Bpifrance.

The project aims to advance SBL01 through manufacturing development, regulatory preclinical studies and an application for clinical trial authorisation. The programme is expected to run from 2026 to 2028.

SeaBeLife plans to conduct a Phase 1 trial in healthy volunteers, followed by a Phase 1b trial in hospitalised patients with acute liver damage. The latter study is intended to include patients with acute liver injury, acute liver failure or acute-on-chronic liver failure.

The company expects the programme to generate initial data on SBL01’s biological activity in humans.

Morgane Rousselot, CEO and co-founder of SeaBeLife, said: “This i-Demo funding represents a crucial milestone for SeaBeLife. It gives us the means to bring our first-in-class drug candidate, SBL01, toward generating its first clinical data.”

Targeting two cell death pathways

SBL01 is designed to inhibit two regulated cell death mechanisms: necroptosis and ferroptosis. These pathways are involved in cellular damage, and their interaction has attracted scientific interest as a potential therapeutic target in acute diseases.

SeaBeLife is developing the dual-inhibition approach for acute liver injury, where extensive damage to liver cells can lead to organ failure. The company also believes the mechanism could have applications in other acute diseases affecting vital organs, although these potential uses remain to be clinically validated.

The candidate has shown activity in several preclinical models, according to SeaBeLife, which also reports encouraging preliminary safety data. The release does not provide detailed results from these studies.

In 2024, SBL01 received orphan drug designation in the European Union for the prevention of acute liver failure. This designation recognises medicines being developed for rare conditions; it does not establish that a treatment is effective or guarantee marketing authorisation.

Clinical development targets an unmet need

Acute liver failure can progress rapidly and is associated with substantial mortality. Acute-on-chronic liver failure, which occurs in people with underlying chronic liver disease, can also lead to severe complications and poor outcomes.

SeaBeLife cites a prospective cohort in which transplant-free survival at 21 days was 56.2% among patients with acute liver failure. It also reports that 28-day mortality in the most severe forms of acute-on-chronic liver failure can reach 76%.

The planned clinical programme will test SBL01 in humans for the first time, with the Phase 1 study intended to precede evaluation in patients. Further clinical evidence will be needed to establish its safety, biological activity and potential therapeutic benefit.

Virginie Fontaine, health sector innovation manager at Bpifrance, said: “This clinical program constitutes a major scientific advance in the treatment of acute liver failure, a group of diseases where there is high medical need.”

The project will also involve French contract research organisations (CROs) and contract development and manufacturing organisations (CDMOs), with the programme expected to support employment and economic activity in France.

The funding marks a significant step in SBL01’s development, but its clinical potential will depend on the results of the planned studies.