Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData.
MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024.
Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.”
However, prior to Rezdiffra’s approval, several companies discontinued development within MASH due to competitive pressures and failure to demonstrate efficacy in clinical trials, resulting in the waning interest from biopharmaceutical companies.
Examples of discontinued development in MASH include Genfit’s oral NR1C1/NR1C2 dual agonist elafibranor in July 2020 and Bristol Myers Squibb’s pegbelfermin in November 2021, both due to failure to demonstrate clinical efficacy in their Phase III trial readouts.
GlobalData’s Pharma Intelligence Center Deals Database reveals that MASH drugs secured over $5.7 billion in total partnership deal value from 2018 to 2024YTD, where 2024YTD is already the top year for MASH partnerships by deal value.
In January 2024, Boehringer Ingelheim signed a partnership deal worth over $2 billion with China-based biotech Suzhou Ruibo Biotechnology and its Sweden-based subsidiary Ribocure Pharmaceuticals to discover and develop siRNA therapeutics for MASH using Ribocure’s RIBO-GalSTAR platform. Boehringer also has a GLP-1/GLU dual agonist survodutide—co-developed with Zealand Pharma—currently in Phase II trials for MASH.
Labya adds, “Boehringer’s collaboration with Suzhou Ruibo Biotechnology currently represents the largest partnership deal for MASH drugs of all time.”
Meanwhile, Novo Nordisk entered a $500 million co-development partnership deal with US-based Cellarity for the discovery and development of a small molecule drug for MASH using Cellarity’s artificial intelligence (AI) platform. This follows Novo Nordisk’s co-development partnership with Gilead Sciences, forged in March 2021, to conduct a Phase II trial of its GLP1R agonist Ozempic (semaglutide) with Gilead’s fixed-dose combination of FXR agonist cilofexor and ACC inhibitor firsocostat in MASH patients with cirrhosis.
Labya concludes, “The recent increase in partnership deals involving innovative MASH drugs in 2024YTD involved large biopharmaceutical companies with prior involvement in MASH drug development, such as Boehringer and Novo Nordisk. Given the large number of MASH drugs in clinical development, including GLP-1 agonists, there may be an increase in partnership deals and mergers and acquisitions involving late-stage clinical MASH drugs over this year.”
Note: Data in the chart includes all announced and completed partnership deals globally from 2018 to 2024YTD. Includes deals where at least one drug involved is developed for metabolic dysfunction-associated steatohepatitis (MASH) with innovator drug type, where stages of development discovery, preclinical, Phase I, Phase II, Phase III, pre-registration, and marketed are considered. Includes deals that have disclosed their deal value in the public domain.