Eli Lilly invests up to US$630M in OliX’s RNAi-based MASH drug

USA—Pharmaceutical giant Eli Lilly has decided to invest up to US$630 million in a promising new drug candidate aimed at treating metabolic-associated steatohepatitis (MASH).

This candidate, identified as OLX75016, has been developed by South Korea-based OliX Pharmaceuticals, utilizing their advanced RNA interference platform.

OliX’s technology works by “turning off” genes known to contribute to diseases, providing a novel approach to addressing challenging health conditions.

As part of the agreement, Eli Lilly has made an initial payment to support a Phase I clinical trial for OLX75016, which commenced in Australia in February 2024.

In this initial study, 58 healthy volunteers will receive both single and multiple doses of the drug to assess its safety and tolerability.

 This early phase is crucial as it establishes the appropriate dosage and identifies any potential side effects before the drug can be tested in patients with MASH..

The current Phase I trial is focused on evaluating OLX75016 for the treatment of both MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease) and liver fibrosis.

Additionally, preclinical studies are exploring OLX75016 as a potential therapy for obesity.

 In these studies, it may eventually be used in combination with semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA) known for its effectiveness in weight management.

A recent securities filing on Korea’s stock exchange revealed a comprehensive agreement valued at $630 million.

This agreement includes not only an upfront payment but also additional milestones to be achieved during the development and commercialization phases of the therapy.

This multi-stage payment plan showcases Lilly’s commitment to expanding its treatment options for MASH, a condition that affects many patients.

Lilly is well-acquainted with the MASH treatment landscape; the company is also exploring the potential benefits of its blockbuster GLP-1RA drug, tirzepatide, which is the active ingredient in Mounjaro and Zepbound, for treating MASH.

A Phase II trial reported in June 2024 (NCT04166773) showed promising results: between 51% and 54.9% of patients experienced improvements in fibrosis without any worsening of their condition after 52 weeks. In contrast, only 21.3% to 25.2% of patients in the placebo group showed similar improvements.

In addition to these developments, Lilly has been making significant investments in its nucleic acid technology.

In August 2024, the company unveiled a US$700 million research and development center in Boston, dedicated to advancing RNA- and DNA-based medicines.

MASH, or Metabolic Associated Steatotic Liver Disease, is a form of non-alcoholic liver disease characterized by fat accumulation, inflammation, and scarring of the liver.

This condition is often associated with other health issues such as obesity and diabetes, making it a challenging disease to manage.

The treatment landscape has faced several challenges, including trial failures and the discontinuation of programs by companies like AstraZeneca.

In June 2023, the U.S. Food and Drug Administration rejected Intercept Pharmaceuticals’ new drug application for its MASH therapy, obeticholic acid, due to safety concerns.

However, in March 2024, Madrigal Pharmaceuticals received approval for Rezdiffra (resmetirom), which is the first treatment option for patients with MASH and moderate fibrosis that does not require a liver biopsy.

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