Innovent and SanegeneBio Begin Phase 1 Trial of IBI3016 (AGT siRNA)

Innovent Biologics, Inc. ("Innovent") and Sanegene Bio USA Inc. (SanegeneBio) have announced that the first participant has been successfully dosed in a Phase 1 First-in-Human (FIH) clinical trial of IBI3016. This trial is a significant milestone in the ongoing collaboration between Innovent and SanegeneBio, aimed at developing groundbreaking treatments for hypertension.

IBI3016, also known by SanegeneBio's R&D code SGB-3908, is a candidate drug under the class of siRNA (small interfering RNA) therapies specifically targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical research indicates that IBI3016 effectively reduces AGT protein levels and related biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys. This reduction leads to a substantial and sustained decrease in blood pressure, with no significant safety concerns such as hypotension reported. Developed using SanegeneBio's next-generation siRNA technology, IBI3016 boasts enhanced drug potency and durability while maintaining safety and tolerability.

In December 2023, Innovent and SanegeneBio entered a strategic partnership to co-develop IBI3016. Innovent holds an exclusive option to manage the future development, manufacturing, and commercialization of IBI3016. The current Phase 1 FIH study (NCT06501586) is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of IBI3016 in both healthy volunteers and patients with mild hypertension. The aim is to support further clinical development.

Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, emphasized the potential of siRNA therapies in managing chronic diseases, particularly cardiovascular and metabolic (CVM) conditions that require long-term control. He highlighted the synergy between SanegeneBio's expertise in siRNA drug development and Innovent’s clinical development skills, which has facilitated the rapid advancement of IBI3016 into clinical trials. Dr. Qian expressed commitment to a science-driven clinical development strategy, aiming to bring innovative treatments to hypertension patients and explore other potential therapeutic areas.

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, underscored hypertension as a significant global unmet medical need. He noted that IBI3016 has demonstrated excellent drug activity, sustained efficacy, and favorable safety and tolerability in preclinical studies. He credited the quick initiation and progress of the Phase 1 study to the strong support from Peking University Third Hospital and the collaborative efforts of the clinical teams at Innovent and SanegeneBio. Dr. Jin looked forward to continued collaboration with Innovent to fully realize the therapeutic potential of IBI3016 and offer a more effective, safer treatment option for hypertension patients.

Hypertension, a common chronic disease affecting over 1 billion people globally, significantly increases the risk of cardiovascular and cerebrovascular diseases and can lead to complications like kidney damage and impaired vision. Factors like aging, obesity, lack of exercise, and unhealthy diets contribute to the rising prevalence of hypertension. While effective treatments exist, they often require daily intake, leading to poor medication adherence due to mild or unnoticed symptoms. This has resulted in less than 20% of patients achieving long-term control. siRNA drugs like IBI3016 offer an alternative by directly reducing AGT expression, providing sustained effects, good safety, and high compliance, making them promising for improved hypertension treatment.

Innovent, founded in 2011, is dedicated to making high-quality biopharmaceuticals accessible globally. The company specializes in developing treatments for cancer, cardiovascular and metabolic diseases, autoimmune disorders, and eye diseases. Innovent has commercialized 10 products and has several others in various stages of regulatory review and clinical trials. The company collaborates with numerous global healthcare giants, including Eli Lilly, Sanofi, and Incyte, adhering to its guiding principle of integrity and action.

SanegeneBio, established in 2021, focuses on developing RNA interference (RNAi) therapeutics using advanced delivery technology. The company has made significant strides in creating a proprietary chemical modification platform and delivery systems for a range of RNA therapeutics. SanegeneBio aims to address unmet medical needs worldwide through scientific innovation, with its first RNAi drug entering the clinical stage and several others in development.

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