In August 2nd, 2024, San Francisco, USA and Suzhou, China / PRNewswire / - Innovent Biologics, Inc. (Stock Code: 01801.HK), a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of novel drugs in the fields of oncology, autoimmunity, metabolism, and ophthalmology, etc., together with Sinovent Pharmaceuticals Co., Ltd. ("Sinovent"), announced that the first subject dosing of IBI3016 in its first-in-human phase I clinical study has been completed.
IBI3016 (the research code of Sinovent: SGB-3908) is a siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension. Preclinical data show that IBI3016 can significantly reduce AGT protein and related biomarkers (ANG I, ANG II) in hypertensive crab-eating monkey serum, achieve significant antihypertensive effect with long-lasting action and no safety issues of hypotension observed. IBI3016 adopts Sinovent's unique and innovative new generation siRNA drug platform technology, which makes the drug more efficient and prolongs the drug efficacy while maintaining the safety and tolerability. In December 2023, Innovent Biologics and Sinovent Pharmaceuticals entered into a strategic partnership to jointly advance the development of IBI3016, and Innovent Biologics obtained the exclusive option for the future development, production and commercialization of the drug in different regions.
This phase I study (NCT06501586) is a single-ascending-dose (SAD) study evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of IBI3016 in healthy subjects and mild hypertensive subjects, to support the subsequent clinical development of IBI3016.
"siRNA drugs have great potential for application in the field of chronic diseases such as cardiovascular and metabolic diseases that require long-term and stable disease control due to their long action time and stable efficacy. Thanks to the advantages of Sinovent Pharmaceuticals in siRNA drug development and the clinical development capabilities of Innovent Biologics in the field of cardiovascular and metabolic diseases, we have efficiently brought IBI3016 into clinical development. We will follow a scientific and rigorous clinical development strategy, closely cooperate with Sinovent Pharmaceuticals, and efficiently advance the clinical development of IBI3016 with high quality, to bring this emerging treatment to a large number of patients with hypertension and other potential indications as soon as possible." said Dr. Qian Lei, Vice President of Clinical Development of Innovent Biologics.
"Hypertension has a huge unmet clinical demand worldwide. IBI3016, as a revolutionary RNAi innovative therapy, has shown excellent drug activity and sustained efficacy in preclinical trials, and has good safety and tolerability. The phase I study of IBI3016 can be started and promoted quickly. We would like to thank the Research Center of Peking University Third Hospital for their strong support, and thank the clinical teams of Innovent Biologics and Sinovent Pharmaceuticals for their joint efforts. We look forward to continuing to work closely with Innovent Biologics to promote the clinical development of IBI3016 with high execution and strictly follow the clinical development plan, fully tap the medical potential of IBI3016, and provide more effective, safe, and patient-compliant treatment options for hypertensive patients as soon as possible." said Dr. Jin Yuyan, Senior Vice President of Clinical and Non-Clinical Development of Sinovent Pharmaceuticals.
About Hypertension
Hypertension is a common chronic disease, with over 1 billion people worldwide suffering from this disease. 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 of the population and the prevalence of risk factors such as obesity, lack of physical activity and unhealthy diet, the incidence of hypertension is still increasing worldwide. There are currently effective antihypertensive treatments in clinical practice, but antihypertensive drugs need to be taken every day. Hypertension is not easy to detect when the symptoms are not severe, which leads to poor medication adherence, thus becoming a major challenge in the current treatment of hypertension. Therefore, less than 20% of hypertensive patients can achieve long-term effective control[i]. SiRNA drugs can directly act to reduce the expression of AGT, which have differentiated advantages such as long-lasting drug efficacy, good safety, and high patient compliance, and are expected to bring better treatment options and long-term benefits to patients.
About IBI3016
IBI3016 (the research code of Sinovent: SGB-3908) is a siRNA drug targeting angiotensinogen (AGT) for the treatment of hypertension, developed based on Sinovent's proprietary nucleic acid drug development platform LEAD (Ligand and Enhancer Assisted Delivery), which inhibits the synthesis of AGT through RNAi. Preclinical data show that IBI3016 can inhibit the synthesis of AGT in the liver, which may lead to a persistent decrease in AGT protein, further reduce angiotensin II (Ang II), and ultimately have the effect of dilating blood vessels and lowering blood pressure. In December 2023, Sinovent Pharmaceuticals and Innovent Biologics jointly announced the development of IBI3016, and Innovent Biologics obtained the exclusive option for the future development, production and commercialization of the drug in different regions.
"Starting with trust and ending with action", developing high-quality biopharmaceuticals that the general public can afford is the ideal and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to the development, production, and sales of innovative drugs to treat major diseases such as tumors, metabolic diseases, and autoimmune diseases. On October 31, 2018, Innovent Biologics went public on the Main Board of the Hong Kong Stock Exchange with stock code: 01801. Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model. It has established a product chain including 23 new drug varieties, covering multiple disease areas such as tumors, metabolic diseases, and autoimmune diseases, of which 6 varieties have been selected for the national "Major New Drug Creation" special project, and 3 products (Sintilimab Injection, brand name: Tyvyt, English trademark: TYVYT; Bevacizumab Injection, brand name: Duligotong, English trademark: BYVASDA; Camrelizumab Injection, brand name: Sulinno, English trademark: SULINNO) have been approved.
"Started with trust, realized through action," developing high-quality biopharmaceuticals that are affordable for the general public is the mission and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to developing, producing, and selling innovative drugs in major disease areas, including cancer, metabolism and cardiovascular diseases, autoimmunity, and ophthalmology. The company has obtained approval for 10 products to be marketed, while 4 varieties are still under NMPA review, 4 new drug molecules have entered Phase III or key clinical research, and another 18 new drug varieties have entered clinical research. The company has deepened its cooperation with domestic and foreign pharmaceutical companies to accelerate drug innovation and has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly and Co, Roche, Sanofi, Adimab, Incyte, and MD Anderson Cancer Center."
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About Saint Bio. Saint Bio was established in early 2021 as a biopharmaceutical company dedicated to developing new 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 is a team of senior experts in the field of nucleic acid drugs with many years of experience in nucleic acid drug development and cutting-edge technical strength in the industry. Since its inception, the company has successfully established a globally leading technology platform for nucleic acid drug chemical modifications and intra- and extra-hepatic delivery, with independent intellectual property rights, and has accelerated the development of RNAi drugs with differentiated advantages. SGB-3403 for the treatment of hypercholesterolemia, SGB-3908 for the treatment of hypertension, and SGB-9768 for the treatment of complement-mediated kidney disease have entered clinical trials, and multiple product pipelines are being developed simultaneously, covering cardiovascular and metabolic diseases, immunologically mediated diseases, and nervous system diseases, among other disease areas. Saint Bio is committed to scientific innovation, creating new RNAi drugs, solving unmet medical needs worldwide, benefiting patients and their families. To learn more, please visit the Saint Bio official website.
Saint Bio was established in early 2021 as a biopharmaceutical company dedicated to developing new 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 is a team of senior experts in the field of nucleic acid drugs with many years of experience in nucleic acid drug development and cutting-edge technical strength in the industry. Since its inception, the company has successfully established a globally leading technology platform for nucleic acid drug chemical modifications and intra- and extra-hepatic delivery, with independent intellectual property rights, and has accelerated the development of RNAi drugs with differentiated advantages. SGB-3403 for the treatment of hypercholesterolemia, SGB-3908 for the treatment of hypertension, and SGB-9768 for the treatment of complement-mediated kidney disease have entered clinical trials, and multiple product pipelines are being developed simultaneously, covering cardiovascular and metabolic diseases, immunologically mediated diseases, and nervous system diseases, among other disease areas. Saint Bio is committed to scientific innovation, creating new RNAi drugs, solving unmet medical needs worldwide, benefiting patients and their families. To learn more, please visit the Saint Bio official website.
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References
[i] Global report on hypertension: the race against a silent killer, WHO 2023,