Jul 09,2024
SanegeneBio's two siRNA drugs were approved for clinical trial in China

Recently, SanegeneBio announced that the clinical trial applications of SGB-9768 injection and SGB-3908 injection were approved in China.

 

SGB-9768 is an siRNA drug targeting the complement component 3 (C3) protein for the treatment of complement-mediated kidney diseases, which was approved for Phase I clinical trial in New Zealand in February 2024. SGB-9768 is delivered to liver using SanegeneBio's proprietary novel GalNAc platform technology, to reduce C3 through RNA interference, thereby inhibiting the complement pathway activity. The preclinical data showed that SGB-9768 could be administered every 3 or 6 months and continuously reduce C3 level, and has superior potency than benchmark compounds, with good safety and tolerability profile. SGB-9768 has the advantages of low dosing frequency and long-term efficacy, and could potentially become China’s first and world-leading siRNA drug targeting C3.

 

SGB-3908 is an siRNA drug targeting Angiotensinogen (AGT) for the treatment of hypertension. SGB-3908 is delivered to liver using SanegeneBio's proprietary novel GalNAc platform technology, to inhibit the synthesis of AGT in the liver, potentially leading to durable reductions of AGT protein, further causing a decrease in angiotensin (Ang) II, and ultimately resulting in vasodilation and lowering blood pressure. The preclinical data showed that SGB-3908 significantly reduced the AGT protein and related biomarkers (ANG I, ANG II) in the serum of cynomolgus monkeys with hypertension, achieving a significant long-term antihypertensive efficacy without safety issues such as low blood pressure.

 

“SGB-9768 and SGB-3908 have the potential to be life-transforming RNAi therapeutics for the treatment of complement-mediated kidney diseases and hypertension respectively, and the quick approval of clinical trial applications has again demonstrated the operation efficiency and dedicated efforts of SanegeneBio team, which is of great significance for us as a biotech with 3-years history. We will advance the clinical trials of these two drug candidates rapidly and make positive progress, aiming to provide more and better treatment options for patients worldwide.” said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio.

 

About complement-mediated kidney diseases

The complement system is an important component of innate immunity, which regulates the adaptive immune response and plays an important role in the immunological and physiological functions in the human body, protecting the body from infections and removing dead cells and apoptotic material. However, dysregulation or overactivation of the complement system can induce inflammation and destroy self-tissues, causing immune damage, which is closely related to the occurrence and development of certain hematologic, ophthalmic, and kidney diseases. Chronic kidney disease (CKD) is a major public health concern worldwide, and in China, the prevalence of CKD is 10.8% among adults [1], meaning 1 in 10 adults has CKD. Complement is involved in the pathogenesis of many kidney diseases, such as IgAN, C3G, and IC-MPGN. Currently, there are limited options in the treatment of complement-mediated kidney diseases, with many complement-targeting drugs still in clinical research stages, indicating significant unmet clinical needs in this field. Complement inhibition holds promise as a new therapeutic target for complement-mediated kidney diseases. C3 is a critical component protein connecting upstream activation pathways to terminal pathways in the complement system. Inhibiting C3 activity has been validated to significantly suppress complement activation, making it a potent therapeutic target for these kidney diseases. Therefore, developing safe and effective siRNA drugs targeting C3 has important clinical application value for complement-mediated kidney diseases.

 

About Hypertension

Hypertension is a common chronic disease that currently affects over 1 billion people worldwide. It not only increases the risk of cardiovascular and cerebrovascular diseases but also potentially leads to complications such as kidney damage and impaired vision. With the aging population and the rising prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the incidence of hypertension is still increasing globally. There are some anti-hypertension drugs in clinical practice, however, these treatments have some disadvantages. For example the anti-hypertension drugs need to be taken every day, and hypertension is difficult to perceive when symptoms are not severe, which can lead to noncompliance in taking medicines. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control. As an alternative solution to address this challenge in the treatment of hypertension, siRNA drugs can directly knockdown the expression of AGT, with the advantages of long duration, good safety, and high compliance, thus is expected to bring better treatment options and long-term benefits to the hypertensive patients.


About SanegeneBio

SanegeneBio is an emerging RNAi-based company developing innovative RNA interference (RNAi) therapeutics driven by the cutting-edge delivery technology. Founded in 2021, SanegeneBio was propelled by a team of industry-leading experts and has operations in both the US and China. Since its inception, SanegeneBio has successfully established proprietary chemical modification platform, hepatic and extrahepatic delivery platforms, enabling tissue-specific delivery of a wide range of RNA therapeutics to efficiently knock down disease-causing genes. Our fast-growing RNAi portfolio covers a broad range of therapeutic areas including cardiovascular and metabolic diseases, immunology-related diseases, and nervous system diseases. Among them, our three RNAi drugs have entered the clinical stage, and several pipelines are in progress simultaneously. SanegeneBio is committed to creating transformational RNAi medicines through striving for scientific innovation to address unmet medical needs worldwide and change the lives of patients and families. 

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