Eli Lilly is paying up to $630m for a Phase I metabolic-associated steatohepatitis (MASH) candidate from South Korea-based biotech OliX Pharmaceuticals, diversifying its pipeline for the disease with an RNA-based asset.
Known as OLX75016, the candidate is an antisense RNAi oligonucleotide developed using OliX’s therapeutic RNAi platform. OliX focuses on developing therapies by inhibiting the expression of genes that cause disease through its technology.
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Lilly will make an initial payment to complete a Phase I trial that kicked off in Australia in February 2024. The study, set to enrol 58 healthy subjects, will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016.
While the ongoing Phase I trial is investigating OLX75016 for the treatment of MASH and liver fibrosis, the candidate is also in preclinical development for the treatment of obesity in combination with glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide.
The $630m agreement includes an upfront payment, as well as development and commercial milestones, according to a securities filing on Korea’s stock exchange.
The deal establishes Lilly with a diverse pipeline to target the large market opportunity within MASH. The drugmaker’s blockbuster GLP-1RA drug tirzepatide – the active ingredient in Mounjaro and Zepbound – is being investigated as a treatment for MASH. In a Phase II trial (NCT04166773) readout in June 2024, Lilly reported that 51% to 54.9% of patients achieved an improvement in fibrosis without worsening of their disease at 52 weeks, compared to 21.3% to 25.2% on placebo.
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By GlobalDataLilly also invested in its nucleic acid infrastructure, unveiling a $700m R&D centre in Boston, US, in August 2024 – a facility focused on developing novel RNA-based and DNA-based medicine.
MASH is a form of non-alcoholic liver disease, which describes a spectrum of conditions like steatosis, inflammation, and fibrosis marked by fat buildup in the liver. The disease, also associated with comorbidities such as obesity and diabetes, has been notoriously difficult to treat.
The MASH treatment landscape has seen multiple trial failures and setbacks, with companies such as AstraZeneca terminating the development of its MASH therapies. In June 2023, the US Food and Drug Administration (FDA) rejected Intercept Pharmaceuticals’ new drug application (NDA) for its MASH therapy, obeticholic acid. The FDA cited concerns over the therapy’s safety profile, especially the potential risks of causing liver injury and diabetes.
In March 2024, Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a type of thyroid hormone receptor beta (THR-beta) agonist, became the first and only approved therapy that does not require a liver biopsy for the treatment of patients with MASH and Stage 2–3 fibrosis.
