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 I, 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.
“SGB-9768 is SanegeneBio’s first siRNA drug in the field of immune related diseases to enter into the clinical development, using our proprietary LEAD™ GalNAc delivery platform, and has demonstrated excellent potency, duration, and safety in the preclinical studies. We will accelerate the phase I clinical trial of SGB-9768 and look forward to the verification and demonstration of the excellent compound in clinical as soon as possible. At the same time, SanegeneBio will continue to deeply explore the full potential of C3 program, push forward its development in various complement mediated diseases, and provide more and better treatment options for patients with immune related diseases.”
said Dr. Weimin Wang, Founder and Chief Executive Officer of SanegeneBio.