Innovent Biologics and SanegeneBio have announced the dosing of the first participant in a Phase 1 clinical trial of IBI3016, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. The First-in-Human (FIH) study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBI3016 in healthy volunteers and patients with mild hypertension.
IBI3016: A Novel siRNA Therapeutic for Hypertension
IBI3016 (SanegeneBio's R&D code: SGB-3908) is designed to reduce serum AGT protein levels, which in turn lowers blood pressure. Preclinical studies in hypertensive cynomolgus monkeys demonstrated that IBI3016 significantly reduced AGT levels and associated biomarkers (ANG I, ANG II), leading to marked and sustained blood pressure reduction without significant safety concerns like hypotension. The drug is developed using SanegeneBio's next-generation proprietary siRNA technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles.
In December 2023, Innovent and SanegeneBio entered into a strategic collaboration to co-develop IBI3016. Innovent maintains an exclusive option to license the future development, manufacturing, and commercialization rights of IBI3016.
Clinical Trial Details and Objectives
The Phase 1 clinical trial (NCT06501586) is a single ascending dose (SAD) study in healthy volunteers and patients with mild hypertension. The primary objectives are to assess the safety and tolerability of IBI3016. Secondary objectives include evaluating the pharmacokinetics and pharmacodynamics to support further clinical development.
Expert Perspectives
Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, highlighted the potential of siRNA therapies in managing chronic diseases, particularly in the cardiovascular and metabolic (CVM) therapeutic areas. "siRNA therapies, due to their long-acting effects and stable efficacy, hold tremendous potential in the management of chronic diseases... Leveraging SanegeneBio's strengths in siRNA drug development and Innovent's clinical development expertise in CVM diseases, we have efficiently advanced IBI3016 into the clinic," Dr. Qian stated.
Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, emphasized the unmet clinical need in hypertension treatment. "IBI3016, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies... Our ultimate goal is to fully realize the therapeutic potential of IBI3016, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension," said Dr. Jin.
The Burden of Hypertension and the Need for Novel Therapies
Hypertension affects over 1 billion people worldwide and increases the risk of cardiovascular and cerebrovascular diseases, as well as kidney damage and impaired vision. While effective anti-hypertension treatments exist, patient adherence is a major challenge, with less than 20% of hypertension patients achieving long-term effective control. siRNA drugs like IBI3016 offer a potential solution by directly reducing AGT expression, providing long-lasting effects, good safety, and high compliance.
