GSK plc (LSE:GSK) has agreed to grant Alfasigma S.p.A. worldwide exclusive rights to develop, manufacture and commercialise linerixibat, an investigational therapy being studied for cholestatic pruritus in patients with primary biliary cholangitis (PBC).
Linerixibat is an ileal bile acid transporter (IBAT) inhibitor currently undergoing regulatory review across several markets, including the United States, the European Union, the United Kingdom, China and Canada. The treatment has received Orphan Drug Designation in the US, EU and Japan, while regulators in China have granted it priority review status for the same indication.
Under the terms of the agreement, GSK will receive an upfront payment of $300m from the Italian pharmaceutical company, with an additional $100m payable upon approval from the US Food and Drug Administration. The FDA’s target decision date under the Prescription Drug User Fee Act (PDUFA) is set for 24 March.
GSK may also receive a further $20m following approvals in the EU and UK, along with up to $270m in additional milestone payments tied to sales performance. In addition, the company will receive tiered double-digit royalties on global net sales of the drug.
Tony Wood, GSK’s Chief Scientific Officer, said the agreement enables the company to concentrate resources on treatments targeting chronic liver diseases such as chronic hepatitis B, metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease (ALD), conditions that collectively account for around two million deaths each year.
Regulatory submissions for linerixibat are supported by data from the Phase III GLISTEN trial, which met its primary and key secondary endpoints. The study demonstrated a rapid and sustained reduction in cholestatic pruritus, as well as improvements in sleep disruption related to itching, compared with placebo.
The drug’s safety profile was reported to be consistent with earlier clinical studies and with the expected mechanism of IBAT inhibition. Linerixibat has not yet been approved for use in any market.
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