SGB-9768 (C3 siRNA) Has Been Approved for Phase 1 Clinical Trial Initiation in New Zealand
Feb 26, 2024
BOSTON, SHANGHAI, and SUZHOU – February 26, 2024, SanegeneBio, a clinical-stage biotechnology company developing innovative RNAi therapeutics, announced that its experimental drug candidate SGB-9768 for the treatment of complement mediated diseases has been approved by the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committee (HDEC) to conduct Phase 1 clinical trials in New Zealand. SGB-9768 is a RNAi-based experimental medicine targeting complement C3 (C3) mRNA, and is SanegeneBio’s second program to enter into clinical development.
The complement system is an important component of innate immunity. It regulates the adaptive immune response, and plays a role in immune surveillance and maintaining homeostasis. Complement plays an important role in the immunological and physiological functions in the human body. 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 some diseases in hematology, ophthalmology and nephrology, such as age-related macular degeneration (AMD), paroxysmal nocturnal hemoglobinuria (PNH), myasthenia gravis (gMG), atypical hemolytic uremic syndrome (aHUS), C3 Glomerulopathy (C3G), IgA Nephropathy (IgAN), thrombotic microvascular disease (TMAs), and other immune related diseases. The complement system consists of over 30 soluble proteins, membrane-bound proteins, and complement receptor components, of which C3 is the most abundant component. It is the convergence of all complement activation pathways and therefore a potential therapeutic target in the relevant diseases. Currently, there is only one approved drug targeting C3 globally, indicating a significant unmet clinical need in this area.
The Phase 1, randomized, double-blind, placebo-controlled, and single-dose escalation study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of SGB-9768 in adult healthy volunteers.
SGB-9768 was 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.
said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio.
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.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. Any statements in this release other than statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "could," "potential," "is/are likely to," "will," "plan," "intend," "aim," "expect," "anticipate," "believe," "hope," "estimate," "project," "forecast," "continue," "target," and similar expressions (or the negative of these terms) are intended to identify forward-looking statements. In addition, statements that refer to future results, trends in our business, expectations for our product pipeline or product candidates, or other characterizations of future events or circumstances are forward-looking statements.
These forward-looking statements are based on our current expectations and assumptions as of the date of this news release and speak only as of such date. They are not guarantees of future performance, and actual results may differ materially from those expressed or implied by forward-looking statements due to a variety of risks and uncertainties, many of which are beyond our control. These risks and uncertainties include, without limitation: risks in research and development and clinical trials; regulatory review, requirements, and timing; trial initiation, site activation, enrollment, and operational execution (including performance by third parties); manufacturing, supply, and quality risks; the impact of competition and new technologies; future market conditions; macroeconomic, political, legal, and social conditions; and our ability to obtain and maintain sufficient funding and other resources. Readers are cautioned not to place undue reliance on these forward-looking statements. We assume no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise, except as required by applicable law.
Medical Information
This press release is provided for informational purposes only and is intended to share scientific and disease-related information. It is not intended as advertising or commercial promotion of any product and does not constitute medical advice, a diagnosis, or a recommendation for any treatment or use of any product. For questions about medical conditions or treatment, please seek advice from a healthcare professional.