GSK plc has entered into a licensing agreement with Alfasigma S.p.A. granting the Italian pharmaceutical company exclusive global rights to develop, manufacture, and commercialize linerixibat, an investigational therapy being studied for a rare liver condition. The deal marks a strategic step for both companies as they seek to expand treatment options for patients with serious liver diseases.
Under the agreement, Alfasigma will take responsibility for the worldwide development and commercialization of linerixibat, a drug candidate currently under regulatory review in several major markets. The therapy is being evaluated for the treatment of cholestatic pruritus in patients with Primary Biliary Cholangitis (PBC), a chronic autoimmune liver disease that can cause severe itching and significantly affect patients’ quality of life.
Linerixibat works by inhibiting the ileal bile acid transporter (IBAT), a protein involved in the recycling of bile acids within the digestive system. By blocking this transporter, the therapy aims to reduce the accumulation of bile acids believed to contribute to intense itching associated with cholestatic liver diseases.
Alfasigma, which operates in more than 100 global markets, has established experience in specialty care and rare disease treatments, particularly within hepatology. The company has previously developed and marketed therapies for serious liver conditions, positioning it as a strategic partner to further advance linerixibat’s development.
Tony Wood, Chief Scientific Officer at GSK, said the partnership reflects the company’s commitment to ensuring promising treatments reach patients through the most suitable partners. He noted that GSK played a significant role in discovering and developing linerixibat and believes Alfasigma’s expertise in PBC and liver diseases will help bring the therapy forward for patients who currently have limited treatment options.
Wood also added that the agreement allows GSK to sharpen its focus on other areas of liver disease innovation. The company is continuing research efforts into treatments for conditions such as Chronic Hepatitis B, Metabolic Dysfunction-Associated Steatohepatitis (MASH), and Alcohol-Associated Liver Disease (ALD), all of which represent major global health challenges and collectively contribute to millions of deaths worldwide each year.
Linerixibat has already received several regulatory designations intended to support the development of therapies for rare diseases. The drug has been granted Orphan Drug Designation in the United States, the European Union, and Japan. In addition, it has received priority review status in China.
Marketing applications for the therapy are currently under review by regulators in the United States, the European Union, the United Kingdom, China, and Canada. These submissions are supported by results from the Phase III GLISTEN clinical trial, which evaluated the drug’s effectiveness in patients with cholestatic pruritus linked to PBC.
According to clinical data from the study, linerixibat demonstrated rapid, significant, and sustained improvements in itching symptoms and sleep disturbances related to the condition when compared with placebo. The drug also showed a safety profile consistent with earlier clinical studies and its mechanism of action as an IBAT inhibitor.
Despite these promising results, linerixibat has not yet been approved for use in any country.
Francesco Balestrieri, Chief Executive Officer of Alfasigma, said the licensing agreement reinforces the company’s commitment to advancing therapies for rare and specialty conditions. He added that Alfasigma’s global presence and hepatology expertise position the company well to lead the worldwide commercialization of linerixibat if regulatory approvals are granted.
If approved, the therapy could offer a new treatment option for patients living with PBC who experience severe itching—a symptom that remains difficult to manage with current therapies.