Innovent and SanegeneBio Start Phase 1 Trial with First Dose of IBI3016

Innovent Biologics, Inc. ("Innovent"), a prominent biopharmaceutical company, and Sanegene Bio USA Inc. (SanegeneBio) have announced the successful dosing of the first participant in a Phase 1 First-in-Human (FIH) clinical trial for IBI3016. This development marks a significant milestone in the treatment of hypertension.

IBI3016, known by SanegeneBio's R&D code SGB-3908, is an siRNA drug candidate that targets angiotensinogen (AGT) to treat hypertension. Preclinical studies have demonstrated that IBI3016 can significantly reduce serum AGT protein levels and related biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys. This reduction has led to substantial and sustained decreases in blood pressure without causing safety concerns such as hypotension. The drug is developed using SanegeneBio's next-generation siRNA technology, which enhances its potency and durability while maintaining a favorable safety and tolerability profile. In December 2023, Innovent and SanegeneBio entered a strategic collaboration to co-develop IBI3016, with Innovent holding an exclusive option to license its future development, manufacturing, and commercialization rights.

The FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of IBI3016 in healthy volunteers and patients with mild hypertension. The aim is to support further clinical development of the drug.

Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, emphasized the potential of siRNA therapies in managing chronic diseases, particularly in cardiovascular and metabolic (CVM) therapeutic areas where long-term disease control is crucial. He noted that the collaboration between SanegeneBio's strengths in siRNA drug development and Innovent's clinical expertise in CVM diseases has enabled the efficient progression of IBI3016 into clinical trials. Dr. Qian reiterated Innovent's commitment to a rigorous, science-driven clinical development strategy and the hope to bring this innovative treatment to a wide range of hypertension patients.

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, highlighted the global unmet clinical need for effective hypertension treatments. She pointed out that IBI3016 has shown superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. Dr. Jin expressed gratitude for the support from the research center at Peking University Third Hospital and the collaborative efforts of the clinical teams at Innovent and SanegeneBio. She looks forward to continued close collaboration with Innovent as they diligently execute the clinical development plan for IBI3016 to achieve positive outcomes. The ultimate goal is to offer a more effective, safer, and patient-friendly treatment option for individuals with hypertension.

Hypertension is a prevalent chronic disease affecting over 1 billion people worldwide. It increases the risk of cardiovascular and cerebrovascular diseases and can lead to complications such as kidney damage and impaired vision. The aging population and the prevalence of risk factors like obesity, lack of physical exercise, and unhealthy diets contribute to the increasing global prevalence of hypertension. Although effective anti-hypertension treatments exist, they often require daily medication, which can lead to poor medication adherence due to the mild or asymptomatic nature of the condition. Less than 20% of hypertension patients achieve long-term effective control. siRNA drugs offer an alternative solution by directly reducing AGT expression, providing long-lasting effects, good safety, and high compliance. These characteristics make them a promising option for better treatment and long-term benefits for patients.

IBI3016, developed using SanegeneBio's proprietary siRNA technology, has shown significant efficacy in preclinical studies, reducing serum AGT protein levels and associated biomarkers, leading to sustained blood pressure reduction without safety concerns. Innovent and SanegeneBio's collaboration is poised to bring this innovative treatment to patients, offering a new hope in managing hypertension.

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