Lilly vs. Boehringer-Zealand Showdown Highlights EASL24

This week’s 2024 Congress of the European Association for the Study of the Liver (EASL24) in Milan, Italy, has shone a spotlight on significant developments in the field of hepatology, particularly concerning metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease affecting millions globally. Major pharmaceutical players such as Eli Lilly and the collaborative duo of Boehringer Ingelheim and Zealand Pharma are at the forefront of this battle, each showcasing promising new data from their respective therapies.

MASH, formerly known as nonalcoholic steatohepatitis (NASH), is an increasingly prevalent liver condition, marked by fat accumulation, inflammation, and fibrosis, which can lead to cirrhosis and liver failure. The disease impacts over 115 million individuals worldwide, with projections suggesting a rise to 357 million by 2030. The urgency for effective treatments is underscored by the FDA's recent approval of Madrigal Pharmaceuticals' Rezdiffra, a liver-directed thyroid hormone receptor (THR)-β agonist, as the first treatment specifically for MASH.

At the EASL24 conference, Eli Lilly presented Phase II data for its drug tirzepatide, which is already approved for type 2 diabetes and weight loss. According to Lilly's findings, 54.9% of MASH patients who received a 5-mg dose of tirzepatide experienced at least a one-stage improvement in liver fibrosis without exacerbation of their condition. The study involved patients with F2 and F3 fibrosis stages, demonstrating that tirzepatide's efficacy was superior to that of a placebo in resolving MASH.

Following closely behind, Boehringer Ingelheim and Zealand Pharma revealed data for their investigational GLP-1 agonist, survodutide. Despite a data leak, their results highlighted a "breakthrough improvement" in liver fibrosis. The data indicated that 64.5% of patients with F2 and F3 fibrosis showed no worsening of MASH, and up to 52.3% of those with fibrosis stages F1, F2, and F3 saw an improvement in fibrosis. These encouraging outcomes have propelled survodutide into Phase III trials, bringing it one step closer to market readiness.

GLP-1 receptor agonists like tirzepatide and survodutide are gaining attention for their potential to improve insulin sensitivity, reduce liver fat, and reverse fibrosis, thereby offering hope for MASH patients. However, analysts emphasize that these drugs are unlikely to monopolize the MASH treatment market. Jefferies and Evercore ISI analysts project substantial market opportunities for Madrigal’s Rezdiffra, estimating U.S. sales to reach between $2.3 billion and $4 billion, respectively. They also foresee a diverse treatment landscape, accommodating varying patient needs through both oral and injectable options.

The competitive field for MASH treatments includes numerous other contenders. Viking Therapeutics, for example, reported that its candidate VK2809 significantly improved secondary histologic endpoints after 52 weeks without worsening fibrosis. Additionally, 89bio is set to present Phase IIb data for pegozafermin, a specially engineered analog of fibroblast growth factor 21. Altimmune and Aligos Therapeutics are also poised to contribute novel insights into MASH treatment.

Despite the complexity and challenges of treating MASH, the potential market is substantial, with estimates suggesting it could reach $25.7 billion by 2032 across major global markets. This lucrative opportunity ensures that pharmaceutical companies will continue to innovate and compete vigorously. As the MASH therapeutic landscape evolves, patient outcomes could see significant improvements, driven by the relentless pursuit of effective treatments by leading biopharmaceutical companies. 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!