SanegeneBio and Innovent Announce FPD in a Phase 1 Clinical Trial of SGB-3908

BOSTON, SHANGHAI, and SUZHOU – August 2, 2024, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, and Innovent today announced the first participant has been successfully dosed in a Phase 1 First-in-Human (FIH) clinical trial of SGB-3908.

SGB-3908 (Innovent's R&D code: IBI3016) is an siRNA drug candidate targeting Angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that SGB-3908 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. SGB-3908 is developed using SanegeneBio's proprietary RNAi technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, SanegeneBio and Innovent entered into a strategic collaboration to co-develop SGB-3908. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of SGB-3908.

This FIH study (NCT06501586) is a Phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) of SGB-3908 in healthy volunteers and patients with mild hypertension, aiming to support the further clinical development of SGB-3908.

Dr. Yuyan Jin, Senior Vice President of Clinical and Non-Clinical Development at SanegeneBio, stated:

• “Hypertension represents a significant unmet clinical need globally. SGB-3908, as a transformative RNAi therapy, has demonstrated superior drug activity, sustained efficacy, and favorable safety and tolerability profiles in preclinical studies. The rapid initiation and progress of the Phase 1 study of SGB-3908 would not have been possible without the strong support from the research center at Peking University Third Hospital, as well as the collaborative efforts of the clinical teams at Innovent and Sanegene. We look forward to continued close collaboration with Innovent as we diligently execute the clinical development plan for SGB-3908 and achieve positive outcomes. Our ultimate goal is to fully realize the therapeutic potential of SGB-3908, offering a more effective, safer, and patient-friendly treatment option for individuals with hypertension.”

Dr. Lei Qian, Vice President of Clinical Development at Innovent Biologics, stated:

• “siRNA therapies, due to their long-acting effects and stable efficacy, hold tremendous potential in the management of chronic diseases, particularly in the cardiovascular and metabolic (CVM) therapeutic areas, where long-term disease control and management are critical. Leveraging SanegeneBio's strengths in siRNA drug development and Innovent's clinical development expertise in CVM diseases, we have efficiently advanced IBI3016 into the clinic. We are committed to a rigorous, science-driven clinical development strategy and will work closely with SanegeneBio to advance the clinical development of IBI3016 with high quality and efficiency, and the hope to bring this innovative treatment to a wide range of hypertension patients as well as other potential disease areas.”

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 while also potentially leading to complications such as kidney damage and impaired vision. With the aging population and the prevalence of risk factors such as obesity, lack of physical exercise, and unhealthy diet, the prevalence of hypertension is increasing globally. Effective anti-hypertension treatments exist, but they have some drawbacks. For example, patients must take anti-hypertension drugs daily, and because hypertension often has mild or no noticeable symptoms, it can lead to poor medication adherence. Poor compliance has become a major challenge in the treatment of hypertension, with less than 20% of hypertension patients achieving long-term effective control. To address this challenge in hypertension treatment, siRNA drugs offer an alternative solution by directly reducing AGT expression. These drugs provide long-lasting effects, good safety, and high compliance, making them a promising option for better treatment and long-term benefits for patients.

About SGB-3908

SGB-3908 is an siRNA drug candidate targeting Angiotensinogen (AGT) for the treatment of hypertension. Preclinical studies have demonstrated that SGB-3908 significantly reduces serum AGT protein levels and associated biomarkers (ANG I, ANG II) in hypertensive cynomolgus monkeys, resulting in marked and sustained blood pressure reduction without observed safety concerns such as hypotension. SGB-3908 is developed using SanegeneBio's proprietary RNAi technology platform, which enhances drug potency and durability while maintaining favorable safety and tolerability profiles. In December 2023, SanegeneBio and Innovent entered into a strategic collaboration to co-develop SGB-3908. Innovent also maintains an exclusive option to license the future development, manufacturing and commercialization rights of SGB-3908.

About SanegeneBio

SanegeneBio is a global, venture-backed, fully-integrated biotechnology company focused on developing RNAi-based therapeutics. Founded in 2021, SanegeneBio is led by a team of RNAi pioneers with unrivaled experience in this Nobel Prize-winning technology. With R&D operations in Boston, Shanghai and Suzhou, our vision clear – RNAi technology will power blockbuster medicines in diverse therapeutic areas, improving the quality and longevity of life for countless patients in the coming years. Our fast-growing pipeline includes experimental medicines for autoimmune nephropathies, obesity, and cardiometabolic indications. SanegeneBio has initiated clinical trials for several experimental medicines, and is committed to developing potential best-in-class and first-in-class therapeutics which leverage our industry-leading and differentiated LEAD™ tissue-selective RNAi delivery technology. For more information, please visit: www.sanegenebio.com and engage with us on LinkedIn.

About Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 10 products in the market. It has 4 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, ‘Start with Integrity, Succeed through Action,’ Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

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