Gilead’s Livdelzi® (Seladelpar) Delivers Statistically Significant Composite ALP Normalization in Phase 3 IDEAL Trial in Primary Biliary Cholangitis (PBC)
Gilead Sciences, Inc. announced positive results from a Phase 3 study in people with primary biliary cholangitis (PBC), showing that treatment with Livdelzi® (seladelpar) led to significantly more patients achieving normalization of alkaline phosphatase (ALP), a key liver marker of disease progression, compared with placebo after 52 weeks. The primary endpoint was defined as a composite of ALP ≤ 1.0× upper limit of normal (ULN) and a ≥ 15% decrease from baseline.
These findings were observed in people with inadequately controlled disease, defined as having ALP levels above the ULN and below 1.67×ULN, with an incomplete response or intolerance to ursodeoxycholic acid (UDCA). This population has been underrepresented in prior randomized trials despite being commonly seen in clinical practice.
The safety profile of seladelpar observed in IDEAL was consistent with previously reported Livdelzi studies, with no new safety concerns identified.
Together with prior pivotal Phase 3 RESPONSE data, which established Livdelzi as the first and only PBC treatment to demonstrate statistically significant reductions in both disease markers and pruritus versus placebo, IDEAL further strengthens support for the efficacy and safety profile of Livdelzi, said Cynthia Levy, MD, Professor of Clinical Medicine and Hepatology, University of Miami Miller School of Medicine. These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67xULN.
In PBC, ALP is a key disease marker associated with disease activity and long‑term outcomes. ALP levels above normal, including in the 1.0 to 1.67×ULN range, are associated with increased risk of progression to liver transplant or death compared with normalized ALP levels.
Advancing and leading in liver disease requires a sustained commitment to addressing areas of persistent unmet need,” said Swati Tole, MD, MS, Senior Vice President, Clinical Development, Inflammation, Gilead Sciences. “As the field moves toward ALP normalization as an important treatment goal in PBC, we are focused on generating robust, clinically meaningful evidence to better understand treatment response and inform care—translating scientific progress into meaningful patient impact.
About PBC
PBC is a chronic, autoimmune disease of the bile ducts that affects approximately 130,000 Americans. PBC is more common in women and causes liver damage that can progress to liver failure and result in the need for liver transplant, if left untreated. The most common symptoms of PBC are pruritus (chronic itch) and fatigue, which up to 80% of people living with PBC can experience and can profoundly compromise quality of life. Symptoms of PBC are often invisible to others and the journey to a PBC diagnosis can be long and challenging.
There is currently no cure for PBC, and treatment goals include reducing the risk of disease progression and reducing the symptoms related to cholestasis (impaired bile flow), such as cholestatic itch. The effect is primarily measured by an improvement in liver biochemical tests, including the improvement and normalization of alkaline phosphatase (ALP) levels, an important marker associated with long‑term outcomes in PBC.
About Livdelzi
Livdelzi (seladelpar) is an oral PPAR‑delta agonist, or delpar, for the treatment of primary biliary cholangitis (PBC). PPAR‑delta is known to regulate key metabolic and liver disease pathways. Preclinical and clinical data indicate that Livdelzi has anticholestatic, anti‑inflammatory, antipruritic, and antifibrotic effects.
Clinical trial data have shown that Livdelzi can support meaningful improvements in key markers of disease activity, including biochemical response and alkaline phosphatase (ALP) normalization, with durable effects observed over long‑term follow‑up in multiple studies.
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. The company has helped to transform hepatitis C from a chronic condition into one that can be cured for millions of people. For individuals living with hepatitis B or D, Gilead’s focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead doesn’t stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted 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.
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