Alfasigma Announces New Linerixibat Data Across PBC and Liver Disease to be Presented at AASLD’s The Liver Meeting 2026

Five presentations will highlight new analyses of linerixibat in cholestatic pruritus associated with primary biliary cholangitis, including an oral presentation and four posters from the Phase 3 GLISTEN study and real-world research

MORRISTOWN, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Alfasigma, a global pharmaceutical company, today announced that five presentations on linerixibat in primary biliary cholangitis (PBC), including one oral presentation and four posters, will be presented by GSK plc (LSE/NYSE: GSK) at American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026, November 5–9 in Denver. The presentations will highlight new analyses on clinically meaningful improvement in cholestatic pruritus, unmet needs and treatment gaps in PBC, and the effects of linerixibat on biomarkers, metabolic profiles and fat-soluble vitamin absorption.

“Cholestatic pruritus remains a major clinical burden in PBC.  In 2026 and beyond it is key that people living with PBC should have pruritus assessed and managed as an integral part of patient care, initiating treatments when needed, based on how the patient in-front of you feels,” said Gideon M. Hirschfield, FRCP, Ph.D., Director, The Autoimmune and Rare Liver Disease Programme, Toronto, and Professor of Medicine, University of Toronto. “The exciting analyses being presented at AASLD broaden the evidence base for linerixibat and, importantly, help define what meaningful improvement looks like from the patient perspective, an essential consideration as we work to improve how pruritus is recognized and managed in clinical practice.”

“Cholestatic pruritus can have a significant and often debilitating impact on people living with PBC, and addressing that symptom burden is an important part of comprehensive PBC care,” said Melissa Leichter, President, U.S. Rare and Specialty Diseases, Alfasigma. “The breadth of linerixibat research being presented at AASLD reflects our commitment to advancing understanding of what meaningful improvement looks like for patients and generating evidence that can help inform how cholestatic pruritus is recognized and managed as part of PBC care.”

Following a license agreement with GSK plc, Alfasigma acquired exclusive worldwide rights to develop, manufacture and commercialize linerixibat. LYNAVOY (linerixibat) is approved for use in the U.S., UK and EU.

Linerixibat presentations at AASLD 2026 include:

Clinical meaningfulness of linerixibat efficacy in pruritus in primary biliary cholangitis (PBC): Post hoc analyses from the Phase 3 GLISTEN study
Poster #1163 (S384) November 5, 12:00–1:00 p.m. MT
Poster Session I – Human Cholestatic and Autoimmune Liver Diseases

Unmet needs in primary biliary cholangitis (PBC): A real-world, cross-sectional survey of the burden of pruritus and treatment gaps from the multinational PBC Disease-Specific Program™
Poster #1209 (S424)
November 5, 12:00–1:00 p.m. MT
Poster Session I – Human Cholestatic and Autoimmune Liver Diseases

Impact of linerixibat on metabolic profiles in patients with primary biliary cholangitis (PBC) in the Phase 3 GLISTEN study
Poster #1186 (S402)
November 5, 12:00–1:00 p.m. MT
Poster Session I – Human Cholestatic and Autoimmune Liver Diseases

Impact of linerixibat, an ileal bile acid transporter (IBAT) inhibitor, on fat-soluble vitamin (FSV) absorption in patients with primary biliary cholangitis (PBC)
Poster #1251 (S460)
November 5, 12:00–1:00 p.m. MT
Poster Session I – Human Cholestatic and Autoimmune Liver Diseases

Improved modulation of pruritic and pharmacodynamic biomarkers with linerixibat added to a stable background of bile acid binding resins or peroxisome proliferator-activated receptor agonists in GLISTEN
Oral Presentation #0027 (S24)
November 7, 5:00–6:30 p.m. MT
Session: Advances in Primary Biliary Cholangitis: Real-World Therapeutics, Biomarkers, and Patient-Centered Outcomes

The Liver Meeting: 2026 Abstracts can be accessed here: https://www.aasld.org/sites/default/files/2026-10/2026%20TLM%20Abstracts.pdf

About cholestatic pruritus in PBC

In PBC, a cholestatic liver disease, bile flow from the liver is disrupted. The resulting excess bile acids in circulation are thought to play a causal role in cholestatic pruritus, an internal itch that cannot be relieved by scratching. Pruritus can occur at any stage of PBC disease or biochemical control.¹ It is a serious condition that can be debilitating, with patients experiencing sleep disturbance, fatigue, impaired quality of life and even sometimes requiring liver transplantation in the absence of liver failure.^2-4- Itch is frequently undocumented in medical records and up to one-third of patients experiencing clinically significant itch do not receive any treatment.^5-6

About the Phase 3 GLISTEN Trial⁷

GLISTEN is a double-blind, randomized, placebo-controlled, phase III trial. The primary and key secondary endpoints of the study were met, demonstrating significant, rapid (at week two), and sustained (over 24 weeks) improvements in cholestatic pruritus (p<=0.003) and itch-related sleep interference (p=0.027) versus placebo.

The primary endpoint of change from baseline in monthly itch score showed linerixibat (n=111) significantly improved itch versus placebo (n=109) over 24-weeks, as measured on a 0-10 numerical rating scale (NRS) for the worst itch (WI-NRS) (least squares [LS] mean difference [95% CI]: -0.68 [-1.14, -0.23], p=0.003). The safety profile of linerixibat was consistent with previous studies and the mechanism of IBAT inhibition. The most frequently reported adverse events were diarrhoea (59%) and abdominal pain (23%), both of which were mild to moderate. Treatment discontinuation due to diarrhoea was in 4% of patients versus <1% in placebo, and abdominal pain in 4% versus none in placebo. 10 Maintenance of efficacy: In the open label, long term extension study (LLSAT), the majority of responders following 24 weeks of linerixibat treatment maintained their response at Week 52: 72.7 % of those with ≥ 2 point response, 80.8 % with a ≥ 3-point response and 81.8 % with a ≥ 4-point response.

U.S. INDICATION

LYNAVOY* is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients.⁸

U.S. IMPORTANT SAFETY INFORMATION

Before using LYNAVOY, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if LYNAVOY will harm your unborn baby.
• Pregnancy Safety Study: Pregnancy outcomes in women who become pregnant while using LYNAVOY is being collected. The purpose of this is to collect information about your health and your baby’s health. You or your healthcare provider should report your pregnancy by calling 1-888-825-5249.
• are breastfeeding or plan to breastfeed. It is not known if LYNAVOY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using LYNAVOY.
  
  

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNAVOY and certain other medicines may interact with each other. Especially tell your healthcare provider if you take:

• bile acid binding resins (used to reduce absorption of bile acids from the intestine), such as cholestyramine or colesevelam. These may reduce the effects of LYNAVOY. If you take any of these medicines, take LYNAVOY at least 4 hours before or 4 hours after taking a bile acid binding resin.
  
  

What are the possible side effects of LYNAVOY?

LYNAVOY may cause serious side effects, including:

• Increased liver enzymes. An increase in liver enzymes (liver-related blood tests) can happen in people who use LYNAVOY and can be serious. Your healthcare provider will do blood tests to check your liver before starting treatment and during treatment with LYNAVOY. Your healthcare provider may need to stop your treatment with LYNAVOY because of an increase in liver enzymes.
• Diarrhea. Diarrhea can happen in people who use LYNAVOY and can be serious. Diarrhea can cause a loss of body fluid (dehydration). Check for signs of dehydration including thirst, dry mouth, urinating less often, or headache. Call your healthcare provider if you have diarrhea that does not go away.
• Fat-Soluble Vitamin (FSV) Deficiency. A condition called FSV deficiency caused by low levels of certain vitamins (vitamin A, D, E, and K) stored in body fat, can happen with LYNAVOY. Your healthcare provider will do blood tests for FSV deficiency before starting and during treatment with LYNAVOY. People with FSV deficiency can bleed more easily or bleed longer or may develop bone fractures. Call your healthcare provider if you have bleeding problems or a bone fracture while using LYNAVOY.
• The most common side effects of LYNAVOY include:
  • diarrhea
  • stomach pain
  • nausea
  • bleeding
  • increased liver enzymes (ALT, AST)
  • headache
  • upset stomach
  • gastroesophageal reflux disease
  • stomach bloating
  • dizziness
  • joint pain
    
    

These are not all the possible side effects of LYNAVOY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information for LYNAVOY.

About Alfasigma

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, . The Group has products in over 100 markets spanning Europe, North and South America, Asia, and Africa. Alfasigma employs approximately 4,000 people. For more information, please visit www.alfasigma.com.

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Alfasigma. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development, or performance of the company and the estimates given here. Alfasigma assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

1. Hirschfield GM, et Lancet Gastroenterol Hepatol. 2026; 11(1): 22–33. doi: 10.1016/S2468-1253(25)00192-X
2. Düll MM, Kremer Clin Liver Dis. 2022; 26(4):727-45. doi: 10.1016/j.cld.2022.06.009
3. Smith H, et Hepatol Commun. 2025; 9(3):e0635. doi: 10.1097/HC9.0000000000000635
4. Mayo MJ, et Dig Dis Sci. 2023;68(3):995-1005. doi: 10.1007/s10620-022-07581-x
5. Lindor KD, et Hepatol. 2019;69(1):394-419. doi: 10.1002/hep.30145
6. Gungabissoon U, et BMJ Open Gastroenterol. 2024; 11;e001287. doi: 10.1136/bmjgast-2023-001287
7. Lancet Gastroenterol Hepatol 2026; 11: 22–33 DOI: 10.1016/S2468-1253(25)00192-X
8. LYNAVOY Prescribing Information. Accessed October 2026: https://www.lynavoyhcp.com/lynavoy-linerixibat-prescribing-information.pdf
   

Alfasigma Media Contacts

Irene Lawlor
pressoffice@alfasigma.com

Priyanka Shah
Elephant Head Communications
PShah@elephantheadcommunicationsllc.com

*LYNAVOY is a trademark of the GSK Group of Companies and is licensed to Intercept Pharmaceuticals, Inc., a wholly owned subsidiary of Alfasigma S.p.A.

Intercept Pharmaceuticals, Inc. is a wholly owned subsidiary of Alfasigma