Eli Lilly, a major U.S. pharmaceutical company that gained explosive popularity for its diabetes and obesity treatment drugs, has acquired the technology for a new drug candidate under development by South Korean biopharmaceutical company OliX Pharmaceuticals for approximately 900 billion won.
OliX announced on the 7th that it agreed to transfer the exclusive rights to the drug candidate OLX702A (substance name OLX75016) for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) and cardiovascular and metabolic diseases to Eli Lilly for approximately 911.7 billion won.
The total contract size is nearing 1 trillion won, and as domestic biopharmaceutical corporations face difficulties due to various internal and external factors, this deal has drawn market interest as the first big deal of the new year. According to this contract, OliX must complete Phase 1 clinical trials for OLX75016. Following that, clinical development and commercialization will be handled by Eli Lilly, which will hold exclusive rights.
◇ Eli Lilly targets MASH treatment market after obesity
Denmark's Novo Nordisk and Eli Lilly have introduced glucagon-like peptide (GLP)-1 class obesity treatments that control blood sugar and suppress appetite, leading the global diabetes and obesity market.
Eli Lilly's diabetes and obesity treatment drugs Mounjaro and Zepbound (ingredient name Tirzepatide) generated $45.0427 billion (approximately 65.39 trillion won) in revenue last year, a 32% increase from the previous year.
While there is still high demand in the U.S. market, recent evaluations indicate that the performance of obesity treatments has fallen short of expectations. There are concerns that the demand for GLP-1 class therapies has been overestimated. Additionally, more latecomer companies are entering the obesity drug development arena. Corporations are in a situation where they must maintain their leading position while proving mid- to long-term growth potential.
The area Eli Lilly is now targeting following diabetes and obesity is metabolic diseases, including MASH and heart failure. Metabolic diseases refer to conditions that arise when there are issues in the metabolic process by which the body breaks down nutrients to obtain energy and eliminate waste products. This is a field that competitors like Novo Nordisk are also eyeing.
MASH is a disease characterized by the accumulation of fat accompanied by inflammation and liver damage. It can lead to conditions such as liver cirrhosis and liver cancer. For a time, it was referred to as non-alcoholic steatohepatitis (NASH), but in 2023, the Global Liver Congress officially changed its name to MASH to emphasize metabolic factors.
Currently, the number of MASH patients worldwide is estimated to exceed 440 million. Despite the increase in the number of patients, there is still no groundbreaking treatment, marking it as a market with significant business opportunities and growth potential for pharmaceutical companies. According to the market research firm Research Nester, the global MASH treatment market is expected to grow from $6.16 billion (approximately 8 trillion won) in 2024 to $50.5 billion (approximately 70 trillion won) by 2037.
Last year, Madrigal Pharmaceuticals' Rezafiprant became the world's first MASH treatment to receive approval from the U.S. Food and Drug Administration (FDA), but it has also faced limitations due to side effects such as arrhythmias and heart failure, as well as cases where the treatment did not work for some patients.
◇ Eli Lilly eyes OLX702A, which increases energy metabolism
RNA interference is a phenomenon that suppresses the expression of specific genes within a cell. Similar to turning off a gene switch, specific RNA molecules can be used to regulate the function of desired genes. OliX is developing therapeutics based on the principle of inhibiting the production of specific proteins that cause diseases by utilizing this RNA interference (RNAi) phenomenon.
OLX702A, which Eli Lilly is targeting, is also one of the candidate substances being developed through OliX's asymmetric RNA interference platform. OLX702A is a gene therapy candidate substance that inhibits the activity (expression) of a specific gene (MARC1). Inhibition of this gene's activity results in increased energy metabolism in the body, leading to reduced body fat. This therapy reduces body fat and improves fatty liver caused by being overweight and obese.
The company confirmed through preclinical tests that OLX702A reduced fat by up to 40% after being administered to monkeys for two months. In tests on mice, a weight reduction effect of 26% was observed over two months. In comparisons with the Zepbound (Tirzepatide) single administration group from Novo Nordisk in a monkey model trial, the effects on weight, body fat percentage, and abdominal circumference reduction were greater. It was confirmed that combining this with Eli Lilly's Zepbound delayed the yo-yo effect.
In other words, the limitation of the GLP-1 class obesity treatments, which suppress appetite, is the yo-yo effect, where appetite returns and weight increases after stopping administration. OLX702A, which raises energy metabolism and reduces body fat, is seen to have the potential to solve this issue.
OliX is currently conducting Phase 1 clinical trials in Australia to confirm the safety and maximum tolerated dose (MTD) of OLX702A. In a preliminary result of clinical trials involving over 60 healthy adults with a BMI of 27 or higher conducted last November, the company noted that they have confirmed promising data regarding body fat reduction through OLX702A. They also reported that after administering OLX702A to patients with metabolic dysfunction related to fatty liver disease (NAFLD), the fat content was reduced by up to about 70%.
Huh Hyemin, a researcher at Kiwoom Securities, noted regarding OliX's technology export, "20% of Eli Lilly's preclinical stage R&D pipeline is based on RNA nucleic acid therapies," adding, "It is noteworthy that they have partnered with a company that has a high understanding of gene therapy." He also mentioned, "The fact that the yo-yo effect was alleviated when combined with low-dose Zepbound during preclinical trials leads to expectations for future expansion of obesity indications."