Madrigal Pharma to Present Rezdiffra™ and Health Economics Research at EASL Congress

Madrigal Pharmaceuticals, Inc., a biopharmaceutical company listed on NASDAQ as MDGL, has announced its participation in the 2024 European Association for the Study of the Liver (EASL) Congress in Milan, Italy, from June 5-8, 2024. The company will present ten data sets, reinforcing its position as a leader in the treatment of nonalcoholic steatohepatitis (NASH) with its drug Rezdiffra.

Bill Sibold, CEO of Madrigal, emphasized the importance of the upcoming data presentations at EASL, highlighting multiple analyses from the MAESTRO Phase 3 program. These presentations will cover new quality of life data, noninvasive test results, and the efficacy of Rezdiffra in patients with metabolic dysfunction- and alcohol-associated liver disease (MetALD). Additionally, real-world data on the economic and human burden of uncontrolled NASH will be presented, showing faster progression to cirrhosis and decompensated cirrhosis than previously understood.

Rezdiffra is an oral, liver-targeted thyroid hormone receptor (THR)-β agonist designed to address key causes of NASH. It is the first approved treatment for NASH and has shown significant results in the Phase 3 MAESTRO-NASH biopsy trial, including improvements in fibrosis and NASH resolution. In the trial, 80% of patients on Rezdiffra 100 mg experienced either improvement or stabilization of fibrosis. The drug is prescribed alongside diet and exercise for adults with noncirrhotic NASH and moderate to advanced liver fibrosis (stages F2 to F3). Ongoing confirmatory trials are required to verify its clinical benefits for continued approval.

Madrigal's presentations at the congress include a late-breaking oral presentation on predicting fibrosis progression in NASH patients, efficacy assessments of different resmetirom doses, and various posters detailing quality of life assessments, noninvasive predictive markers, and treatment of subgroups with potential MetALD. Additional posters will cover analyses of fibrosis biomarkers, machine learning models to predict fibrosis stages, and the economic impact of NASH progression in Medicare patients.

The MAESTRO-NASH trial, involving 1759 patients with biopsy-confirmed NASH, has shown Rezdiffra achieving its primary endpoints of NASH resolution and fibrosis improvement, as well as a key secondary endpoint related to LDL cholesterol reduction. Published in the New England Journal of Medicine in February 2024, the trial results indicated significant improvements in liver enzymes and fibrosis biomarkers compared to placebo. The trial's ongoing 54-month outcomes phase aims to provide further confirmatory data on Rezdiffra's clinical benefits.

NASH, a severe form of nonalcoholic fatty liver disease (NAFLD), poses a growing health burden worldwide and increases risks for severe liver and cardiovascular complications. Madrigal estimates around 1.5 million diagnosed NASH patients in the U.S., with roughly 525,000 experiencing moderate to advanced liver fibrosis. The company plans to target approximately 315,000 of these patients under specialist care during Rezdiffra's launch.

In 2023, medical societies and patient groups globally redefined the disease nomenclature to reduce stigma, renaming NAFLD to metabolic dysfunction-associated steatotic liver disease (MASLD) and NASH to metabolic dysfunction associated steatohepatitis (MASH). This rebranding aims to encompass various forms of liver diseases related to fat buildup, with MASH patients typically having at least one comorbidity such as obesity, hypertension, dyslipidemia, or type 2 diabetes.

Rezdiffra, prescribed alongside diet and exercise, addresses moderate to advanced liver fibrosis in NASH patients without cirrhosis. It is currently approved based on demonstrated improvements in NASH and fibrosis, with ongoing studies required to confirm its clinical benefits. Patients need to inform their healthcare providers about all medical conditions and medications before starting Rezdiffra, which may interact with other treatments and has potential side effects including liver injury and gallbladder problems.

Madrigal Pharmaceuticals continues to advance its research and development efforts, aiming to solidify Rezdiffra’s role in treating NASH and exploring further potential indications and commercial opportunities.