By Fineline Cube 
Shanghai‑based Rona Therapeutics Inc. announced on September 15, 2025 that it has formally submitted a Clinical Trial Application for its proprietary drug, RN3161, to the Human Research Ethics Committee (HREC) in Australia. The application marks a critical step toward initiating first‑in‑human studies of this next‑generation siRNA therapeutic.
What Is RN3161?
- GalNAc‑siRNA Platform – RN3161 is designed as a GalNAc‑conjugated siRNA that specifically targets the INHBE gene. The drug is built on Rona’s proprietary GAIA platform, allowing precise delivery to hepatocytes and sustained gene silencing.
- Unique Mechanism – By silencing INHBE, RN3161 reduces adipose tissue while sparing lean body mass—a profile that sets it apart from current weight‑loss agents that often compromise muscle.
- Long‑Lasting Effect – Preclinical data show that a single dose of RN3161 can maintain gene suppression for over 180 days, potentially enabling a dosing schedule of only once or twice per year. This reduced frequency could markedly improve patient adherence and overall treatment value.
Why Australia?
Australia’s robust regulatory framework and strong clinical research infrastructure make it an attractive initial market for early‑stage therapeutics. The HREC approval process is designed to safeguard participant safety while expediting development timelines, positioning RN3161 for a swift path to clinical validation.
Next Steps
Upon HREC approval, Rona Therapeutics will initiate Phase I studies to evaluate safety, tolerability, and pharmacodynamics in healthy volunteers. Success in this pivotal trial could open the door to larger obesity and metabolic disorder programs, leveraging the drug’s once‑a‑year dosing advantage to disrupt the current therapeutic landscape.-Fineline Info & Tech