Gilead to Present Latest Research Across Key Liver Disease Indications at the European Association for the Study of the Liver Congress 2024

Rhea-AI Summary

Gilead Sciences (GILD) will present new research at the EASL Congress 2024 in Milan, focusing on liver diseases like PBC, HDV, HCV, HBV, and MASH/Fibrosis. Highlights include interim results from the ASSURE study on seladelpar for PBC, a Phase 2b study on Hepcludex® for HDV, and a Phase 3 study on bulevirtide monotherapy. Gilead's data aims to support WHO's goal to eliminate viral hepatitis by 2030. The company will also launch an HCV awareness program in Italy. Key findings span safety, efficacy, and long-term impacts of treatments, underscoring Gilead's commitment to addressing unmet needs in liver disease therapeutics.

Positive

• Interim results from ASSURE study show promising long-term efficacy and safety of seladelpar for PBC.
• Pooled analysis reveals tenofovir-based antiviral therapy reduces long-term incidence of liver cancer in chronic HBV.
• Final results from MYR204 study demonstrate efficacy and safety of Hepcludex® for HDV.
• Phase 3 MYR301 study confirms bulevirtide's efficacy as monotherapy.
• Launch of national HCV awareness program in Italy supports WHO's hepatitis elimination goals.
• Broad range of abstracts across multiple liver diseases highlights Gilead's comprehensive research efforts.

Negative

• Seladelpar and bulevirtide remain investigational agents not yet approved by regulatory authorities, posing uncertainty for investors.
• Progression risks of liver diseases like HDV and PBC are high, indicating ongoing challenges despite treatment advancements.
• Potential market barriers and access issues for antiviral therapies in HCV patients, particularly in areas with restrictive policies.
• Long-term outcomes for off-treatment patients with chronic HBV are uncertain, warranting further investigation.

– Key Findings from PBC, HDV, HCV, HBV and MASH/Fibrosis Studies Affirm Commitment to Drive Life-changing Science in Liver Disease –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, June 5-8, 2024 in Milan, Italy. Key findings from more than 25 abstracts will include:

• Interim results for two years from the ASSURE study which evaluate the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC);
• Results of a pooled analysis, showcasing the effects of tenofovir-based antiviral therapy in reducing long-term incidence of primary liver cancer in people living with chronic hepatitis B (HBV);
• Final results of the Phase 2b MYR204 study evaluating the efficacy and safety of Hepcludex^® (bulevirtide) in combination with pegylated interferon alfa-2a (PegIFN) in patients with compensated chronic hepatitis delta virus (HDV); and
• A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of bulevirtide as monotherapy.

“These data underline Gilead’s commitment to drive life-changing science and create healthier futures for people living with liver disease. We look forward to presenting our latest research at EASL, as we strive to deliver novel medicines to populations with high unmet medical need,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The breadth of our data being presented across viral and inflammatory liver diseases, speaks to our commitment to driving positive change at every step of a person’s journey. Transforming lives goes beyond treatment, and our research, innovation and partnerships span initial awareness and education, through to screening, diagnosis, path to care and ongoing management to address current unmet needs.”

To drive efforts in supporting the World Health Organization’s (WHO) goal to eliminate viral hepatitis as a public health threat by 2030, Gilead will also present real-world data in hepatitis C (HCV) and launch a national HCV awareness program in Italy to raise awareness of the disease. In collaboration with EASL, Gilead will launch “Epatite C Mettiamoci un Punto” (Hepatitis C Let’s Put a Stop to it) in Milan to raise awareness about the disease and encourage people to get tested for HCV through EASL’s “Love Your Liver” Campaign.

Advancing Treatment options in PBC

New data demonstrating the long-term efficacy and safety profile of investigational seladelpar for the treatment of primary biliary cholangitis (PBC) will be presented at EASL. These include the first interim data from the Phase 3 open-label ASSURE study that includes people who received a second year of seladelpar treatment following their initial participation in the Phase 3 RESPONSE study. The study also includes patients with insufficient response to first-line PBC treatment, ursodeoxycholic acid (UDCA). These data evaluate the composite biochemical response (alkaline phosphatase (ALP) < 1.67x upper limit of normal (ULN), ALP decrease ≥ 15%, and total bilirubin ≤ ULN) and ALP normalization, as well as pruritus for seladelpar in the treatment of PBC which is a rare, chronic, cholestatic liver disease mainly affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the U.S.) that impairs liver function and quality of life. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.

Key Findings in HDV

At the EASL Congress, Gilead will present 13 abstracts in HDV, including the Week 144 (48 Weeks off-treatment) results of the Phase 2b MYR204 study of bulevirtide with or without peginterferon alfa-2a (PegIFN) in people with chronic HDV and compensated liver disease (GS-002), and results from the pivotal Phase 3 MYR301 study assessing the efficacy and safety of bulevirtide as monotherapy as a late-breaker presentation (LB-309).

Further highlighting Gilead as a leader in HDV research, a sub-analysis of the MYR204 study (OS-122) evaluating intrahepatic virological outcomes 24 Weeks off-treatment will be presented. A pooled analysis of the MYR203, MYR204 and MYR301 studies (TOP-400) discussing the impact of nucleos(t)ide analogues alongside bulevirtide 48 Weeks off-treatment will also be shared as an oral presentation. These data evaluate the efficacy profile of bulevirtide for people living with HDV, which is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure, liver cancer and liver-related death.

Key Abstracts at EASL 2024:

ID	Abstract Title
PBC
OS-019	Efficacy and safety of seladelpar in patients with primary biliary cholangitis and compensated liver cirrhosis in the open-label, long-term ASSURE safety study: interim results
THU-098	Appraising gain of an extended 2-year placebo-controlled trial in primary biliary cholangitis: challenges for evaluating clinical outcomes
SAT-175	PPAR-delta activation with seladelpar regulates cholangiocyte inflammation
THU-119	Seladelpar treatment increases fatty acid beta-oxidation and serum carnitine levels in patients with primary biliary cholangitis consistent with increased expression of the carnitine transporter OCTN2 and the mitochondrial carnitine shuttle
SAT-177	Assessment of PPAR-delta target engagement in mouse liver assessed by single nuclei sequencing following a single oral dose of seladelpar
LB-283	Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis (PBC): interim results for 2 years from the ASSURE study
HDV
GS-002	48-week off-therapy efficacy and safety of bulevirtide in combination with pegylated interferon alfa-2a in patients with chronic hepatitis delta: Final results from MYR204
LB-309	Efficacy and safety of 144 weeks of bulevirtide 2 mg or 10 mg monotherapy from the ongoing Phase 3 study, MYR301
TOP-400	Impact of bulevirtide given with or without nucleos(t)ide analogues on 48-week virologic outcomes in patients with chronic hepatitis delta virus infection
WED-395	Undetectable hepatitis delta virus RNA at the end of treatment with bulevirtide and pegylated interferon alpha-2a is an important predictor of 48 weeks sustained virologic response in chronic hepatitis delta
OS-122	Bulevirtide in combination with pegylated interferon alfa-2a shows a sustained off-treatment response in the liver
FRI-435	Serological and nucleic acid testing laboratory screening rates for hepatitis delta virus among adult patients in the United States
HCV
THU-374	Description of age, sex, and characteristics of hepatitis C patients in the SVR10K study: a real-world SOF/VEL analysis performed across five global regions
WED-498	Impact of direct acting antiviral market access policy barriers and restrictions for Hepatitis C patients: a database analysis of claims from states with and without Medicaid restrictions
WED-447	Age at incident cirrhosis in individuals with hepatitis C virus infection: a US administrative claims analysis
HBV
WED-397	Tenofovir-based antiviral therapy reduces long-term incidence of hepatocellular carcinoma in chronic hepatitis B patients
FRI-390	Off-treatment outcomes after discontinuing tenofovir-based treatment in hepatitis B e antigen-positive and hepatitis B e antigen-negative patients with chronic hepatitis B virus
MASH/Fibrosis
TOP-264	Paired assessment of Enhanced Liver Fibrosis (ELF) and Fibrosis-4 (FIB-4) scores is associated with an elevated risk of liver-related clinical events in patients with advanced fibrosis due to metabolic dysfunction-associated steatohepatitis (MASH)

For more information, including a complete list of abstract titles being presented at the meeting, please visit the EASL website.

In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for bulevirtide 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted conditional MA from the EC in July 2020 to provide access to people living with HDV urgent access to treatment. Bulevirtide also received full MA in Great Britian in August 2023 and in Switzerland in February 2024. In the U.S. and outside of the European Economic Area, bulevirtide is an investigational agent that is not approved for any use. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and has not been approved anywhere globally.

Seladelpar is an investigational compound and is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority; its safety and efficacy have not been established.

About PBC

PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP, ALT, and GGT, enzymes found primarily in the liver, as well as total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.

About HDV

HDV is considered the most aggressive or severe form of viral hepatitis, associated with more rapid progression towards liver-related death and liver cancer in people with hepatitis B (HBV). On average, HDV progresses to cirrhosis within 5 years and to liver cancer within 10 years. Nearly 5% of people who have a chronic infection with HBV are estimated to have HDV, equating to 12-15 million people worldwide. The prevalence of HDV infection is largely underestimated due to lack of universal testing of HBV-positive individuals for HDV.

About Gilead Sciences in Liver Disease

For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. We have helped transform hepatitis C from a chronic condition into one that can be cured for millions of people. For people living with hepatitis B or D, our focus on advancing our medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, we’re working to deliver advanced treatments for people living with primary biliary cirrhosis (PBC). But our commitment doesn’t stop there. Through our ground-breaking science and collaborative partnerships, we strive to create healthier futures for everyone living with liver disease. We are committed to a future without liver disease.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex (bulevirtide) and seladelpar; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV and/or seladelpar for the treatment of PBC, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240522704668/en/

Meaghan Smith, Media

public_affairs@gilead.com

Jacquie Ross, Investors

investor_relations@gilead.com

Source: Gilead Sciences, Inc.

FAQ

What notable results will Gilead present at EASL Congress 2024?

Gilead will present over 25 abstracts, including studies on seladelpar for PBC, Hepcludex® for HDV, and bulevirtide monotherapy.

When and where is the EASL Congress 2024 taking place?

The EASL Congress 2024 is scheduled for June 5-8 in Milan, Italy.

What is the significance of Gilead's research on seladelpar?

Seladelpar's interim results from the ASSURE study show long-term efficacy and safety for treating primary biliary cholangitis (PBC).

How does tenofovir-based antiviral therapy impact chronic HBV patients?

Pooled analysis results show that tenofovir-based antiviral therapy reduces the long-term incidence of primary liver cancer in chronic hepatitis B (HBV) patients.

What new data will be presented on Hepcludex® at EASL 2024?

Final results from the Phase 2b MYR204 study and the pivotal Phase 3 MYR301 study will showcase Hepcludex®'s efficacy and safety for chronic hepatitis delta virus (HDV).

What is Gilead's plan to support WHO's hepatitis elimination goal?

Gilead will present real-world data on hepatitis C (HCV) and launch a national HCV awareness program in Italy, in collaboration with EASL.