Boehringer Ingelheim Partners with Ochre Bio in $1 Billion Deal to Advance First-in-Class Regenerative Therapies for MASH and Chronic Liver Disease

On April 23, 2024, Boehringer Ingelheim (hereinafter referred to as “BI”) announced a research and development collaboration with RNA therapeutics developer Ochre Bio, focusing on the research and development of potential first-in-class regenerative therapies for chronic liver disease (CLD), such as cirrhosis due to advanced metabolic dysfunction-associated steatohepatitis (MASH).

Under the terms of the agreement, Ochre Bio will receive $35 million in upfront and near-term milestone payments, as well as subsequent development, regulatory, and commercialization milestone payments that could exceed $1 billion (approximately RMB 7.2 billion).

Under the terms of the agreement, Ochre Bio will leverage its proprietary drug discovery platform, integrating machine learning and big-data human databases, advanced imaging, deep genomic phenotypic analysis, in-house RNA chemistry research, and exclusive patented ex vivo human organ perfusion models, to facilitate the identification, characterization, and validation of multiple innovative regenerative targets for chronic liver diseases. Boehringer Ingelheim aims to develop novel therapies that enhance the liver’s self-repair capacity to prevent or reverse disease progression.

Ochre Bio, an innovative drug development company, is dedicated to developing genomic medicines that revitalize transplanted livers, with the ultimate goal of applying these therapies to treat non-alcoholic fatty liver disease and other metabolic disorders. Founded in 2019 and headquartered in Oxford, UK, Ochre Bio completed a $9.6 million seed funding round in June 2021.

In May 2022, Ochre Bio announced the launch of its “Liver ICU” platform—a research center at BioLabs@NYULangone, a biopharmaceutical incubator in New York City—to evaluate the efficacy of novel RNA therapies on the human liver. Five months after the announcement, in October 2022, Ochre Bio completed a $30 million Series A financing round. To date, Ochre Bio has analyzed thousands of donated human livers to understand the causes of disease and explore related RNA therapies.

Notably, Ochre Bio has also established a research and development base in Taiwan, China, operating under the official English name Ochre Bio. The R&D center primarily leverages single-cell RNA sequencing, genomics, and high-throughput screening to identify disease-causing genes and develop combination RNA therapeutics, which are tested in ex vivo viable donor livers. In January 2021, Ochre Bio completed a more comprehensive liver genomic atlas, with multiple GalNAc-siRNA candidates poised to enter clinical trials.

This move can be seen as BI’s further expansion in the field of chronic liver diseases, including metabolic dysfunction-associated steatohepatitis (MASH). After all, just six years ago, BI established partnerships with Dicerna Pharmaceuticals and MiNA Therapeutics, covering the use of siRNA and RNA-targeting technologies to treat MASH.

On January 3, 2024, BI announced a collaboration with Ribo Life Science to jointly develop innovative small nucleic acid therapies for the treatment of non-alcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). This partnership leverages Ribo Life Science’s leading expertise in early-stage research and clinical development of siRNA drugs. Specifically, Ribo’s RIBO-GalSTAR technology platform enables specific targeting of pathogenic genes in hepatocytes and selective inhibition of their mRNA, thereby facilitating the development of RNA interference (RNAi) therapies. The total potential value of the transaction exceeds $2 billion.

Boehringer Ingelheim (BI) continues to exert strong momentum without slowing down, having already achieved some success in the MASH field. In February 2024, BI announced the Phase 2 trial results of survodutide, a glucagon/GLP-1 receptor agonist developed in collaboration with Zealand Pharma, which demonstrated favorable efficacy in improving liver cirrhosis.

After all, the subsequent March was also turbulent for giants like BI.

Resmetirom, under Madrigal Pharmaceuticals, has become the first FDA-approved drug for MASH. Just prior to this, on March 4, publicly traded Akero Therapeutics announced positive 96-week results from its Phase 2b HARMONY study of efruxifermin, an investigational MASH therapy. The striking data triggered a surge in Akero’s stock price. Consequently, although Madrigal has secured the “first-mover” title, how long this advantage will last remains debatable. With a growing number of promising candidates nearing approval, it seems that delaying entry into the MASH market may already be too late.

From this perspective, the two close collaborations BI entered into in 2024 also highlight such a sense of urgency.