OliX’s OLX501A Demonstrates Greater Visceral Fat Reduction Relative to a Global Comparator in Obese Non-Human Primates

• Head-to-head study in obese non-human primates showed a 29.2% reduction in visceral fat with OLX501A versus 10.0% with a global comparator, after adjustment for baseline values and food intake
• Robust and sustained pharmacodynamic activity supports the potential for a differentiated profile as an RNAi-based obesity therapy
• Data suggests the potential for selective fat reduction and improved body composition, which may support future partnering and out-licensing discussions

SEOUL, South Korea--(BUSINESS WIRE)--OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced new preclinical data from a head-to-head study in obese non-human primates showing that OLX501A, its ALK7-targeting obesity program, achieved greater visceral fat reduction relative to a globally developed comparator compound. These findings add to the growing body of evidence supporting the potential of OLX501A to deliver a differentiated body-composition profile among next-generation obesity therapies.

The study was conducted in obese monkeys selected based on predefined criteria for body weight and body fat. OLX501A and the comparator were each administered subcutaneously at 3 mg/kg, with two doses given one month apart. Study endpoints included target gene knockdown, changes in visceral fat volume assessed by MRI, and pharmacodynamic biomarker responses.

At Day 49, MRI analysis showed that after adjustment for baseline values and food intake, visceral fat volume in the OLX501A group was reduced by 29.2%. Under the same conditions, the comparator group showed a 10.0% reduction, while visceral fat increased by 11.1% in the control group over the study period. These findings suggest a differentiated effect of OLX501A on visceral fat reduction in this study setting.

At Day 70, ALK7 mRNA knockdown measured in subcutaneous adipose tissue reached approximately 90% in the OLX501A group, a level generally comparable to that observed with the comparator. Despite generally similar target engagement in subcutaneous fat, OLX501A showed greater reduction in visceral fat, suggesting that its pharmacology may translate target inhibition into meaningful effects on fat metabolism.

Pharmacodynamic biomarker analyses further supported the differentiated activity profile of OLX501A. Expression of ADRB3, a downstream biomarker associated with lipolysis following ALK7 inhibition, was approximately two-fold higher in the OLX501A group than in the comparator group at Day 28, and this difference was maintained at Day 70. Taken together, these data support the potential for robust and sustained pharmacodynamic activity in adipose tissue.

OLX501A is based on OliX’s proprietary OASIS-Adipose platform, an adipose-targeted siRNA technology designed to enable durable gene silencing in fat tissue while limiting exposure in non-target organs. The company has continued to optimize both the chemistry and delivery architecture of the platform to enhance adipose delivery efficiency and sustain pharmacologic activity over time.

In earlier mouse studies, OLX501A demonstrated delivery to adipose tissue following subcutaneous administration, durable suppression of target gene expression, and the potential for selective reduction of fat mass while preserving lean mass. Taken together with the new non-human primate data, these findings support the possibility that OLX501A may contribute to improved quality of weight loss by directly modulating fat biology rather than relying primarily on appetite-focused approaches.

Across the global obesity treatment landscape, clinical development is increasingly focused not only on weight reduction, but also on broader measures of body composition and metabolic health, including visceral fat, total fat, liver fat, and preservation of lean mass. In parallel, regulatory authorities in major markets have increasingly emphasized sustained reductions in excess body weight, long-term weight maintenance, and broader assessment of metabolic and cardiovascular risk factors in obesity drug development. In this context, data suggesting selective fat reduction and a differentiated body-composition profile may become increasingly relevant in both development strategy and partnering discussions.

Dong Ki Lee, Chief Executive Officer of OliX Pharmaceuticals, said, “OLX501A is being developed with the goal of going beyond weight reduction alone and supporting improved quality of weight loss through selective fat reduction while preserving lean mass. In this head-to-head study in obese non-human primates, OLX501A showed greater visceral fat reduction than the comparator despite generally similar levels of ALK7 knockdown in subcutaneous tissue, which we believe provides encouraging support for our development strategy.”

He continued, “In the current obesity treatment landscape, high-quality preclinical data showing robust and sustained pharmacology, meaningful effects on visceral fat, and the potential for improved body composition may increase the attractiveness of a program for global partners. Based on these data, we believe OLX501A may offer a differentiated profile, and we plan to continue advancing the program toward submission of a clinical trial application in the first half of 2027.

About OliX Pharmaceuticals

OliX is a biotechnology company developing therapeutics that regulate disease-causing gene expression through RNA interference (RNAi). The company is advancing pipeline programs across diseases, including several in clinical development.

OliX develops therapeutics using its proprietary OASIS (OliX Advanced Small Interfering RNA System) platform, designed to enhance gene-silencing efficiency and enable tissue-specific delivery. Its locally administered RNAi programs target hair loss, age-related macular degeneration (AMD), and hypertrophic scars. OliX is building pipelines for metabolic dysfunction-associated steatohepatitis (MASH), obesity, and cardiometabolic disorders using hepatocyte-specific delivery technology.

Under its mid- to long-term growth strategy, the “OliX 2.0 Roadmap,” the company is expanding RNAi applications by developing delivery platforms targeting the central nervous system (CNS) and adipose tissue, advancing follow-on pipelines, and pursuing differentiated therapeutics across disease areas.

Learn more: https://www.olixpharma.com/eng