BIONEER CORPORATION

Bioneer Subsidiary siRNAgen Therapeutics, IND Approval for  Phase 1b Trial of IPF Drug ‘SRN-001’

Bioneer announced on the 5th that its subsidiary siRNAgen Therapeutics (hereinafter “siRNAgen”) has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) for a Phase 1b clinical trial of its idiopathic pulmonary fibrosis (IPF) therapeutic candidate SRN-001.

SRN-001 is an siRNA-based new drug developed using Bioneer’s proprietary SAMiRNA™ platform. It is the world’s first therapeutic candidate designed to selectively inhibit the expression of amphiregulin (AREG), a key factor driving fibrosis, thereby targeting a wide range of fibrotic diseases.

The SAMiRNA™ platform overcomes the innate immune toxicity typically associated with siRNA therapeutics. Because the approach suppresses the production of disease-causing proteins at the source, it is expected to deliver more fundamental therapeutic benefits. By inhibiting the expression of AREG, a major driver of fibrosis, SRN-001 is anticipated to provide a differentiated and long-lasting therapeutic effect compared to existing treatments—ultimately improving patient quality of life and enhancing treatment convenience.

Thanks to this novel mechanism of action and steady clinical progress, siRNAgen has attracted the attention of major global pharmaceutical companies. Following confirmation of safety and proof-of-concept (PoC) in the Phase 1b study, the company expects active discussions with global pharma partners regarding co-development and licensing opportunities. Additionally, because AREG is implicated in various fibrotic diseases of the kidney and liver—and even contributes to anticancer drug resistance through tumor-associated fibrosis—the company sees potential for expansion into oncology indications.

A company spokesperson stated, “SRN-001 is a next-generation treatment capable of overcoming the limitations of current therapies and has strong potential to become a global blockbuster. With this Phase 1b trial, we will accelerate clinical development, deliver new treatment options to patients, and advance our global partnering strategy.”