South Korea’s Olix Strikes $660M Deal with Eli Lilly for Phase 1 MASH candidate

OliX Pharmaceuticals (KOSDAQ: 226950), a leading developer of RNA interference (RNAi) therapeutics, has entered into a global licensing agreement with Eli Lilly and Company (Lilly) for OLX75016, a Phase 1 treatment candidate for metabolic-associated steatohepatitis (MASH) and other cardiometabolic diseases. Valued at approximately 910 billion won ($660 million), the agreement grants Lilly global rights to OLX75016, a siRNA candidate targeting the MARC1 enzyme. OliX identified this target by analyzing genomic variants associated with MASH and other liver diseases. OliX is currently conducting a Phase 1 trial in healthy volunteers in Australia, with Lilly covering the costs to complete the study.

Targeting MARC1 Enzyme: OLX75016 for MASH, Liver Fibrosis, and Other Cardiometabolic Indications

OLX75016 targets the MARC1 enzyme, a key discovery made through a genome-wide association study (GWAS). OliX identified this target after analyzing genomic variants linked to MASH and other liver diseases. Preclinical studies have shown the drug’s potential to address MASH, liver fibrosis, and other cardiometabolic indications. OliX is now moving forward with developing OLX75016 as a novel therapeutic for treating MASH and related conditions.

Dong Ki Lee, Ph.D., CEO of OliX Pharmaceuticals, expressed his excitement about the new partnership with Eli Lilly, emphasizing its importance for the future of OLX75016. He stated, “This collaboration with Lilly marks a significant step forward for OLX75016’s development and its potential to improve treatment outcomes for a range of metabolic conditions – MASH and other cardiometabolic indications. Partnering with an industry leader like Lilly enables us to advance innovative solutions that address medical needs with a strong focus on both efficacy and safety. Together, we aim to develop therapies that offer meaningful benefits for patients and drive progress in metabolic health.”

Overview of MASH and its Progression to Severe Liver Diseases

MASH is a liver condition marked by triglyceride accumulation in liver cells, typically in the absence of alcohol consumption. This leads to liver inflammation and fibrosis, which can progress to severe liver diseases like cirrhosis, liver cancer, and liver failure. In the U.S., approximately 5.8% of adults are affected by MASH, and globally, the condition impacts an estimated 400 million people. The MASH treatment market is expected to reach a total size of 36 trillion won by next year. OliX is currently conducting a Phase 1 trial of the candidate with healthy volunteers, with Lilly covering the costs to see the study through.

By securing this global licensing deal, Lilly is strengthening its position in both siRNA and the MASH space. The company signaled its growing interest in RNA-based therapies last year with the launch of a $700 million nucleic acid R&D center at the Boston Seaport. Now, by securing global rights to OLX75016, Lilly further strengthens its pipeline and expands its MASH treatment portfolio. The licensing agreement is a significant milestone for both companies, particularly for OliX, as it marks a key step toward gaining a foothold in the MASH treatment market.

Lilly is also investing heavily in its MASH pipeline. Tirzepatide, the GLP-1 drug in Mounjaro and Zepbound, stands as the company’s highest-profile MASH candidate. In June 2024, Lilly reported promising Phase 2 MASH data. The company is also working to identify biomarkers that could support accelerated FDA approvals for liver diseases. With early-phase candidates like siRNA inhibitors targeting SCAP and PNPLA3, Lilly’s ongoing investments are positioning it for success in the evolving MASH market.

OliX Pharmaceuticals Stock Surges Following Technology Transfer Deal with Eli Lilly

OliX Pharmaceuticals saw its stock price jump in early trading on the 11th. The company hit the ceiling price for two consecutive days after announcing a major technology transfer agreement with Eli Lilly.

As of 9:10 a.m. on the 11th, OliX was trading at 34,700 won (USD 26.06), an increase of 8,000 won (USD 6.02), or 29.96%, from the previous day. The stock surged directly to the ceiling price during early trading. On the evening of the 7th, OliX Pharmaceuticals revealed that it had signed a global licensing agreement worth 910 billion won (USD 684 million) with Eli Lilly. Following the announcement, OliX’s stock price rose by 29.93% on the 7th, hitting the ceiling price, and the company has continued to see an upward trend for three consecutive days.

South Korean Pharmaceutical Companies Export MASH Treatment Technologies to Global Leaders

South Korea’s pharmaceutical industry has been actively developing MASH treatments through both exporting technology and independent research. Companies like Olix, Hanmi Pharmaceutical, and Yuhan Corp. have successfully exported their MASH treatment technologies to global leaders like Eli Lilly, Merck (MSD), and Boehringer Ingelheim. This approach allows these companies to take advantage of the larger firms’ resources and market reach while continuing their own development.

In 2019, Boehringer Ingelheim completed a phase 1b trial for a candidate imported from Yuhan Corp. for 1.19 trillion won, with results expected to be released in the first quarter of this year. Similarly, MSD imported a candidate from Hanmi Pharmaceutical for 1.1 trillion won in 2020. This candidate received fast-track designation from the FDA in June last year, which should help speed up the drug’s approval process.

MASH Market Overview in the 7MM: Prevalence and Market Value

The 7 major markets–MM— (United States, EU4 – Germany, France, Italy, Spain, the United Kingdom, and Japan) MASH market was valued at USD 2.1 billion in 2023. There were an estimated 42 million prevalent cases of MASH in the 7MM in 2023, with around 15 million diagnosed cases. This number is projected to increase by 2034.

Leading companies in the MASH space include Inventiva Pharma (Lanifibranor [IVA337]), Novo Nordisk A/S (Semaglutide), Cirius Therapeutics (Azemiglitazone [MSDC-0602K]), Akero Therapeutics (Efruxifermin [EFX]), and 89bio (BIO89-100 [Pegozafermin]). Other notable companies involved in MASH drug development include Boehringer Ingelheim (Survodutide [BI 456906]), Pfizer (BOS-580), and Merck & Co. (Ervogastat [PF-06865571] + Clesacostat [PF-05221304]). A range of promising therapies are in development, including Tirzepatide, LPCN1144, GR-MD-02 (Belapectin), and Saroglitazar Magnesium. Other therapies under investigation include Denifanstat (TVB-2640), ION224, Miricorilant (CORT118335), and Semaglutide/Cilofexor/Firsocostat.

In March 2024, Madrigal Pharmaceuticals received accelerated FDA approval for REZDIFFRA (resmetirom). This drug is a once-daily THR-ß agonist for non-cirrhotic MASH with fibrosis stages F2–F3, based on positive Phase III trial results from MAESTRO-NASH. Developing treatments for MASH is challenging due to its complex causes, but the approval of the first FDA-approved drug for MASH has shown that development is possible. Despite being late to the market, domestic companies can compete successfully if they have unique advantages.

Olix Pipeline: RNAi Therapeutics for Metabolic, Liver, and Hair Disorders

In addition to OLX75016 for MASH, OliX Pharmaceuticals develops a pipeline of therapeutics targeting various conditions, focusing on RNAi therapeutics for dermal, ophthalmic, pulmonary, and liver diseases. The company claims to overcome limitations in stability and delivery while minimizing siRNA toxicity. OliX developed OLX101A to address hypertrophic scars and keloids by inhibiting collagen production through targeting CTGF mRNA. OliX designed OLX104C to target androgenic alopecia by inhibiting androgen receptor expression and delaying hair loss progression.

For age-related macular degeneration, OliX develops OLX301A as a potential therapy for both dry and wet AMD, targeting retinal damage. OLX301D focuses on subretinal fibrosis and wet AMD, targeting CTGF mRNA to prevent vision loss in patients unresponsive to anti-VEGF therapies. OliX targets metabolic dysfunction-associated steatohepatitis (MASH) with OLX702A to improve liver conditions and expand its indication to obesity. OliX aims to target the hepatitis B virus with OLX703A by reducing serum HBV surface antigen levels, applicable to patients resistant to existing antiviral treatments. These assets reflect OliX’s focus on RNAi therapeutics across various therapeutic areas.

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Author

Bernice Lottering