BIONEER CORPORATION

siRNAgen Therapeutics Reports Positive Phase 1a Results for first in class antifibrotic RNAi therapy, SRN-001

- Initial Trial in Australia Affirms Safety, Tolerability, and Pharmacokinetics, Setting the Stage for Advanced Clinical Studies

On August 20st, siRNAgen Therapeutics (hereafter referred to as siRNAgen), a subsidiary of Bioneer, announced that it had confirmed positive results of the Phase 1a clinical trial for SRN-001, a first-in-class RNAi-based antifibrotic drug. The Clinical Study Report (CSR) is expected in the coming months.

Earlier this year, siRNAgen successfully completed a pivotal study in Australia for SRN-001, a groundbreaking RNAi-based antifibrotic therapy that targets amphiregulin (AREG). AREG, a challenging target to drug with the more traditional small molecule and antibody approaches, is a critical driver of fibrosis downstream of TGF-beta that is elevated in patients suffering from fibrosis. Launched in September of the previous year, this study represents the first-in-human trial for both SRN-001 and siRNAgen’s innovative SAMiRNA platform. SAMiRNA platform leverages a unique double-conjugate technology that ensures effective delivery directly to key immune cells, while maintaining exceptional safety and efficacy for minimally modified oligonucleotide therapeutics.

In the study, SRN-001 has demonstrated robust safety and tolerability in humans. In this single-ascending dose study on healthy volunteers, no dose-limiting toxicities were found even at levels up to ten times higher than the effective dose observed in preclinical models of the disease. Furthermore, pharmacokinetic analyses confirmed a dose-proportional increase in drug exposure consistent with the preclinical studies, contributing to the successful completion of the Phase 1a trial. Notably, SRN-001 has demonstrated meaningful efficacy across a range of animal models for idiopathic pulmonary fibrosis (IPF), chronic kidney disease (CKD), metabolic associated steatohepatitis (MASH), and cancer.

Idiopathic pulmonary fibrosis (IPF) is a chronic and progressive disease characterized by abnormal accumulation of collagen in the lungs, leading to the loss of lung function. The 5-year survival rate after diagnosis is only 40%, making the demand for new treatments high, with clinical trial participation often considered a treatment option. According to the global market research firm Research and Markets, the IPF treatment market is projected to reach $6.1 billion (approximately 8.4 trillion KRW) by 2030. While existing IPF drugs have only delayed disease progression, SRN-001 has the potential to be a disease-modifying treatment through its AREG targeting mechanism.

June Park, CEO of siRNAgen, stated, “We are pleased to announce the successful completion of the first human study of the SAMiRNA platform,” and added, “This achievement demonstrates the dedication of our team and the potential of SRN-001 to change the paradigm of fibrosis treatment.” She also noted, “We look forward to advancing to the next stages of development through strategic partnerships and providing this potentially disease-modifying therapy to patients in need.”

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