BIONEER CORPORATION

Bioneer Receives Final Clinical Phase 1a Report for SRN-001 

- SRN-001 Proven Safe, Paving the Way for Expanding Indications

- SAMiRNA Platform Achieves First Successful Application in Humans, Setting the Stage for a Global Drug Market Challenge

Bioneer announced on the 25th that it has received the final clinical Phase 1a report for SRN-001, a next-generation drug candidate under development. SRN-001 is the first successful human application of Bioneer’s innovative SAMiRNA platform. This milestone highlights the platform's potential for expanding applications to a variety of medical indications.

The Phase 1a clinical trial evaluated the safety and tolerability of SRN-001. The study provided comprehensive safety data, confirming dose-proportional exposure with no observed cytokine changes or anti-SRN-001 antibodies, which addresses a significant challenge in siRNA therapy—immunogenicity. Furthermore, all safety evaluations, including electrocardiogram assessments, showed no significant changes before or after administration, even at the highest tested dose. These findings confirm the safety of a single intravenous dose at maximum trial levels.

SRN-001 is a drug candidate with a novel mechanism that differs from existing therapies, showing strong potential for treating various intractable diseases, including idiopathic pulmonary fibrosis (IPF). Based on these results, Bioneer plans to expand its drug development efforts to address other conditions such as chronic kidney disease (CKD), metabolic-associated steatohepatitis (MASH), and anti-obesity therapies.

Bioneer is preparing to select the most promising indications for efficient clinical development and advance subsequent trials. The company is also devising strategies for global market entry, including in-house clinical trials, co-development with partners, or licensing out to global pharmaceutical companies. Discussions for potential collaborations and partnerships are already in progress.

Dr. Joon Young Park, CEO of SirnaGen Therapeutics, commented, “SRN-001 targets intractable diseases with an innovative mechanism distinct from existing therapies. The Phase 1a results validate the R&D capabilities of SirnaGen and Bioneer in oligonucleotide-based drug development and confirm the potential of the SAMiRNA platform. We will rapidly advance global clinical trials and commercialization efforts.”