Rona Therapeutics, a global leader in next-generation RNA interference therapies, has announced the submission of RN5681 to the Australian Human Research Ethics Committee, marking the first clinical step for the company’s bi-valent siRNA. The Phase 1 trial is expected to begin dosing in the first quarter of 2026. RN5681 is a GalNAc-conjugated, dual-targeting siRNA engineered to simultaneously silence PCSK9 and LPA, two well-established contributors to atherosclerotic cardiovascular disease. By combining LDL cholesterol reduction and Lp(a) lowering in a single molecule, the therapy is designed to achieve substantial and sustained lipid improvements and address residual cardiovascular risk that remains despite current treatments.

Health Technology Insights: Catalight Chief Clinical Officer Dr. Doreen Samelson Wins 2025 Merit Award

Alex DePaoli, MD, Chief Medical Officer at Rona Therapeutics, highlighted the potential of the bi-valent approach. He stated that RN5681 could transform cardiovascular care by targeting two critical risk factors with a single therapy that may only require dosing every six to twelve months. Dr. DePaoli also presented Rona’s multi-target RNAi platform at the 22nd Global Cardiovascular Clinical Trialists Forum in Washington, DC, emphasizing the company’s growing recognition for innovation in dual and multi-target siRNA therapies.

Health Technology Insights: Innovent Biologics Forms Global Partnership with Takeda

Stella Shi, CEO of Rona Therapeutics, noted that RN5681 is the first bi-valent siRNA emerging from their proprietary plug-and-play technology platform. She described the submission as a major milestone in Rona’s mission to bring advanced RNAi therapies to patients worldwide. Shi added that the company is enthusiastic about the potential for future multi-valent siRNA therapies in cardiometabolic and obesity-related conditions, aiming to address complex comorbidities with innovative RNAi solutions. This advancement underscores Rona’s commitment to pioneering next-generation therapies that can deliver transformative benefits in cardiovascular health.

Health Technology Insights: Avantor Appoints Sanjeev Mehra to its Board of Directors

To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com