SanegeneBio Announces FSD in Phase 1 Clinical Trial of SGB-9768

BOSTON, SHANGHAI, and SUZHOU – August 6, 2024, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, announced the first subject dosed in a Phase 1 clinical trial of SGB-9768 in Huashan Hospital of Fudan University in Shanghai, China.

SGB-9768 is an RNAi-based experimental medicine targeting the complement component 3 (C3) mRNA for the treatment of complement-mediated kidney diseases. The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, and single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SGB-9768 in healthy volunteers. Preclinical studies have demonstrated that SGB-9768 has superior potency, safety and tolerability profile than industry benchmarks. SGB-9768 has the advantages of low dosing frequency and long-term efficacy. Since entering the Phase 1 clinical trial in New Zealand in early 2024, SGB-9768 has been dosed in multiple cohorts of subjects, demonstrating a favorable safety and tolerability profile.

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

• “This is another important milestone for SGB-9768. The rapid initiation and progress would not be possible without the strong support from the research center at Huashan Hospital of Fudan University, as well as the great efforts of our teams. This also shows that SanegeneBio is in a leading position in the R&D of innovative siRNA drugs for the treatment of complement-related diseases. SGB-9768 is developed using SanegeneBio's proprietary GalNAc platform with a favorable safety profile. We look forward to the performance of SGB-9768 in the clinical trials, and hope that SGB-9768 can bring more and better treatment options to the global patients with complement-mediated diseases.”

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, 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 SGB-9768

SGB-9768 is an experimental RNAi-based drug candidate targeting the complement component 3 (C3) mRNA for the treatment of complement-mediated kidney diseases, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), Immune complex-mediated membranoproliferative glomerulonephritis (IC-MPGN). SGB-9768 is developed using SanegeneBio's proprietary GalNAc platform, to reduce C3 through RNA interference, thereby inhibiting the complement pathway activity. Preclinical studies have demonstrated that SGB-9768 could be administered bi-annually to reduce circulating C3 protein, has superior potency to industry benchmarks, and a strong tolerability profile.

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.

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