On August 2, 2024, Suzhou Sanegenbio Biomedical Co., Ltd. ("SANEGENEBIO") and Innovent Bio jointly announced that the first-in-human (FIH) Phase I clinical study of SGB-3908 injection has completed the first subject dosing.SGB-3908 (Innovent Bio's R&D code: IBI3016) is an siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical trial data show that SGB-3908 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. SGB-3908 utilizes SANEGENEBIO’s uniquely innovative next-generation siRNA drug platform technology, which enhances the drug’s superior activity and prolonged efficacy while maintaining excellent safety and tolerability. In December 2023, SANEGENEBIO and Innovent Bio entered into a strategic collaboration to jointly advance the development of SGB-3908. Meanwhile, 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 SGB-3908 in healthy subjects and subjects with mild hypertension, aimed at supporting the subsequent clinical development of SGB-3908.Hypertension is a common chronic disease, with over 1 billion people currently affected worldwide. Hypertension not only increases the risk of cardiovascular and cerebrovascular diseases but also may 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 diet, 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. Since hypertension is often asymptomatic or has mild symptoms, patients may forget to take their medication, leading to poor compliance, which has become a major challenge in the treatment of hypertension. 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 advantages such as long-lasting effects, good safety, and high patient compliance. This innovative approach holds promise to provide better treatment options and long-term benefits for patients.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 the synthesis of AGT through RNAi. Preclinical trial data shows that SGB-3908 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 achieving vasodilation and blood pressure reduction. In December 2023, SANEGENEBIO and Innovent Bio jointly announced a collaboration to develop SGB-3908, with Innovent Bio obtaining the option for future development, manufacturing, and commercialization of the drug in different regions.
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