Innovent Biologics and Sanegene Bio Announce First-in-Human Dosing of IBI3016 (AGT-Targeting siRNA) in Phase 1 Clinical Trial for Hypertension

August 2, 2024DayInnovent Bio (HKEX: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs in major disease areas such as oncology, autoimmune disorders, metabolic diseases, cardiovascular conditions, and ophthalmology, and Suzhou SanegenBio Co., Ltd. ("SanegenBio"), jointly announced that the first-in-human (FIH) Phase I clinical study of IBI3016 has completed the dosing of its first subject.

IBI3016 (SANEGENEBIO R&D Code: SGB-3908) is an siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical trial data shows that IBI3016 significantly reduces AGT protein and related biomarkers (ANG I, ANG II) in the serum of hypertensive cynomolgus monkeys, achieving a marked blood pressure-lowering effect with long-lasting action and no observed safety issues such as hypotension. IBI3016 utilizes SANEGENEBIO's uniquely innovative next-generation siRNA drug platform technology, which provides the drug with superior activity, prolonged efficacy, and excellent safety and tolerability. In December 2023, Innovent Bio entered into a strategic collaboration with SANEGENEBIO to jointly advance the development of IBI3016. Additionally, Innovent Bio obtained exclusive options for future development, manufacturing, and commercialization rights of the drug in different regions.

This FIH study (NCT06501586) is a Phase I clinical trial with a single ascending dose (SAD) design to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of IBI3016 in healthy subjects and subjects with mild hypertension, aimed at supporting the subsequent clinical development of IBI3016.

Dr. Lei Qian, Vice President of Clinical Development at Innovent Bio, stated: "siRNA-based drugs have great potential for application in chronic diseases such as cardiometabolic disorders that require long-term stable disease control, due to their long-lasting effects and stable efficacy. Thanks to SANEGENEBIO's expertise in siRNA drug development and Innovent’s strong clinical development capabilities in the cardiovascular-metabolic field, we have efficiently advanced IBI3016 into clinical trials. We will follow a scientific and rigorous clinical development strategy, closely collaborate with SANEGENEBIO, and advance the clinical development of IBI3016 with high quality and efficiency, aiming to bring this novel therapeutic approach to a broad population of patients with hypertension and other potential indications as soon as possible."

Dr. Jin Yuyan, Senior Vice President of Clinical and Non-clinical at SANEGENEBIO, stated: "There is a significant unmet clinical need for hypertension globally. IBI3016, as a transformative RNAi innovative therapy, has demonstrated excellent drug activity and prolonged efficacy in preclinical trials, with good safety and tolerability. The rapid initiation and advancement of the IBI3016 Phase I study are particularly thanks to the strong support from the Peking University Third Hospital Research Center. We also appreciate the joint efforts of the clinical teams at INNOVENT BIO and SANEGENEBIO. We look forward to continuing our close collaboration with INNOVENT BIO, strictly adhering to the clinical development plan with high execution, to fully advance the clinical development of IBI3016 and achieve positive results. Our goal is to fully realize the medical potential of IBI3016 and provide hypertension patients with more effective, safe treatments as soon as possible."Treatment options with good patient compliance."

AboutHypertension

Hypertension is a common chronic disease, with over 1 billion people worldwide currently affected. Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but can also lead to complications such as kidney damage and vision loss. With the aging population and the prevalence of risk factors like obesity, lack of physical activity, and unhealthy diets, the global prevalence of hypertension continues to rise. Although there are effective antihypertensive treatments available in clinical practice, antihypertensive drugs need to be taken daily, and since hypertension is often asymptomatic in its mild stages, patients may forget to take their medication, leading to poor compliance—a major challenge in current hypertension management. As a result, less than 20% of hypertensive patients achieve long-term effective control. To address this treatment bottleneck, siRNA drugs can directly reduce the expression of AGT, offering long-lasting effects, good safety, and high patient compliance.Differentiated advantages are expected to bring better treatment options and long-term benefits to patients.

AboutIBI3016

IBI3016 (SANEGENEBIO R&D Code: SGB-3908) is an siRNA drug targeting Angiotensinogen (AGT) for the treatment of hypertension. It was developed based on SANEGENEBIO's proprietary small nucleic acid drug development platform, LEAD™ (Ligand and Enhancer Assisted Delivery), and inhibits AGT synthesis through RNAi. Preclinical trial data shows that IBI3016 can inhibit the synthesis of AGT in the liver, potentially leading to a sustained reduction in AGT protein, further resulting in decreased levels of Angiotensin (Ang) II, ultimately causing vasodilation and blood pressure reduction. In December 2023, SANEGENEBIO and Innovent Bio jointly announced their collaboration to develop IBI3016, with Innovent Bio...Obtain the option for future development, production, and commercialization of the drug in different regions.

AboutSANEGENEBIO

SANEGENEBIO, established in early 2021, is a biopharmaceutical company dedicated to developing novel small nucleic acid drugs based on RNA interference (RNAi) technology, with research and development centers in both China and the United States. The founding team consists of seasoned experts in the field of nucleic acid drugs, bringing years of experience in nucleic acid drug development and cutting-edge technical expertise. To date, the company has successfully built a globally leading proprietary platform for nucleic acid drug chemical modification and intrahepatic and extrahepatic delivery technologies, accelerating the development of differentiated RNAi drugs. Among these, SGB-3403 for treating hypercholesterolemia, SGB-3908 for hypertension, and SGB-9768 for complement-mediated kidney diseases have entered clinical trials, while multiple other pipelines are also underway, covering disease areas such as cardiovascular and metabolic diseases, immune-mediated conditions, and neurological disorders. SANEGENEBIO is committed to scientific innovation, creating novel RNAi drugs to address unmet global medical needs and benefit patients and their families.

About Innovent Bio

"Start with trust, achieve through action." Developing high-quality biopharmaceuticals that are affordable for the general public is the mission and goal of Innovent Bio. Founded in 2011, Innovent Bio is committed to the development, production, and sales of innovative drugs in major disease areas such as oncology, metabolic and cardiovascular diseases, autoimmune disorders, and ophthalmology. The company has received approval for 10 products to be marketed, with 4 additional products currently under review by the NMPA. Four new drug molecules have entered Phase III or pivotal clinical trials, and another 18 new drug candidates have entered clinical studies. The company accelerates drug innovation through in-depth collaborations with pharmaceutical enterprises both domestically and internationally. Innovent Bio has established over 30 strategic partnerships with international collaborators such as Eli Lilly, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center.