BIONEER CORPORATION

Bioneer Registers Patent for SRN-001 as an Anti-Obesity Composition in Australia

Bioneer and its subsidiary, siRNAgen Therapeutics (hereafter siRNAgen), announced on the 24th that their siRNA-based therapeutic candidate SRN-001 has been granted a patent in Australia for its use as a composition to prevent and treat obesity. This adds to the existing patents in South Korea, Russia, and Japan, solidifying SRN-001’s intellectual property portfolio in multiple countries.

SRN-001 targets Amphiregulin (AREG), a protein believed to play a role in the formation and growth of adipocytes (fat cells). By inhibiting the proliferation and differentiation of adipocytes, SRN-001 is the world’s first-in-class therapeutic candidate targeting AREG for obesity treatment. In preclinical trials using transgenic obese mouse models, SRN-001 demonstrated positive effects such as a reduction in visceral fat by approximately 60%, decreased body weight and fat cell size, and suppression of fatty liver. These findings suggest SRN-001 has potential for not only treating obesity but also addressing various metabolic disorders such as diabetes and fibrosis.

Bioneer and siRNAgen plan to conduct further studies to verify SRN-001’s potential for commercialization as an obesity treatment. The current market for obesity treatments is dominated by GLP-1-based drugs. According to Goldman Sachs, the obesity treatment market is expected to grow to $100 billion by 2030, driven by the rising global prevalence of obesity. Unlike GLP-1 treatments, SRN-001 represents a novel therapeutic mechanism. Bioneer aims to expedite the development of SRN-001 by leveraging safety data from its ongoing clinical trials of SRN-001 for fibrosis and expanding indications for this compound.

AREG, the target of SRN-001, is a protein expressed in various fibrotic and cancer tissues and has recently been highlighted in numerous studies as a key factor in disease progression. By inhibiting AREG, SRN-001 is expected to be a disease-modifying drug not only for obesity but also for a range of cancers and fibrotic diseases. Notably, there are currently no fundamental treatments for fibrosis. The global market for skin fibrosis therapies alone is projected to exceed $100 billion by 2032, according to a 2024 report by Business Research Insights.

SRN-001 acts by inhibiting the differentiation and proliferation of fibroblasts, which contribute to fibrosis. Last year, SRN-001 successfully demonstrated its safety and tolerability in a Phase 1a clinical trial conducted in Australia with healthy volunteers. Bioneer stated that SRN-001 is protected under patents in major markets, including the United States. The company, alongside its research partners, has published multiple studies supporting the potential of SRN-001 to treat various types of fibrosis. These include collaborative research on pulmonary fibrosis with Professor Chun-Kun Lee’s team at Brown University and research on kidney fibrosis with Professor Eun-Young Lee’s team at Soonchunhyang University.

A Bioneer representative commented, “SRN-001 is a first-in-class therapeutic candidate targeting the root causes of fibrosis and obesity. With patents secured in major advanced economies, the compound has market potential estimated at $200 billion.” The representative further noted, “In Australia’s Phase 1a trials, SRN-001 exhibited outstanding safety even when administered at doses ten times higher than the effective dose, showing no toxicity. Compared to FDA-approved siRNA therapies, SRN-001 demonstrated superior safety. If future clinical trials validate its disease-modifying effects, SRN-001 could emerge as a groundbreaking therapeutic in the global market and serve as a platform technology applicable to a wide range of siRNA-based drugs.” ###