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siRNAgen Therapeutics Advances SRN-001 to Phase 1a Clinical Trials

Aug 4, 2023

Novel siRNA Immunology Drug SRN-001 Breaks New Ground in with Phase 1 Trials in Australia, Leveraging Proprietary SAMiRNA™ Technology for Extrahepatic Delivery

siRNAgen Therapeutics, a pioneer in the development of next-generation RNAi therapeutics, announced that it will commence Phase 1a clinical trials in Australia this upcoming month for its novel drug SRN-001, aimed at treating fibrotic diseases such as those affecting the lungs, kidneys, and liver.


The Human Research Ethics Committee (HREC) in Australia has approved the commencement of Phase 1a clinical trials targeting Idiopathic Pulmonary Fibrosis (IPF). The trial will be a randomized study of 24 healthy adults consisting of four dosage groups ranging from 15 to 210 mg and a placebo group. The safety and efficacy of SRN-001 will be determined by monitoring drug concentration in the blood and the range of administered doses.


siRNAgen Therapeutics plans to complete the clinical trials at CMAX, an independent clinical trial agency in Australia, by the end of the year. Following the trials, based on the results and reports of Phase 1a, siRNAgen intends to apply for an IND to the U.S. Food and Drug Administration (FDA) for repeated-dose Phase 1b and early Phase 2a trials.


SRN-001, based on the proprietary SAMiRNA™ platform by siRNAgen, is the first siRNA candidate in the world to degrade AREG (amphiregulin) mRNA, a key growth factor involved in fibrosis. siRNA (small interfering RNA) is a powerful drug modality that can address the fundamental source of diseases by degrading disease-causing mRNA. These groundbreaking therapies provides potential improvements to patients' quality of life due to longer dosing intervals.


Dr. June Park, CEO of siRNAgen Therapeutics, commented on this major milestone, stating, "The initiation of SRN-001's clinical trials is a testament to the dedication, innovation, and tireless efforts of our team. This is a significant step forward not only for siRNAgen but, more importantly, for the many patients worldwide who have had no disease-modifying therapies to turn to. We're committed to pushing the boundaries of what's possible in RNAi therapies, working diligently across areas of immunology and central nervous system disorders to pioneer treatments that can fundamentally change patients' lives."


SRN-001 has shown promising results in various preclinical studies, effectively suppressing fibrosis in lung, kidney, and liver fibroses without any major side effects when administered intravenously and subcutaneously. Broad preclinical studies on IPF have demonstrated an excellent safety profile and potential for lung function improvement.


Given the projected growth of the global IPF treatment market, estimated to reach $6.1 billion by 2030, the development and success of SRN-001 could offer a vital new treatment pathway for patients suffering from this and other fibrotic diseases.


According to Dr. Park, "The global health community has been long awaiting an effective treatment for fibrotic diseases. Our groundbreaking SAMiRNA™ platform has the potential to fundamentally change the treatment paradigm for these debilitating conditions and help improve patients' lives worldwide."


About siRNAgen Therapeutics:

siRNAgen Therapeutics, a subsidiary of Bioneer, is a next-generation biotechnology company specializing in the development of small interfering RNA (siRNA) therapies for the treatment of immunology and central nervous system (CNS) diseases. Their proprietary SAMiRNA™ platform leverages modular chemistry to enable extrahepatic delivery, pioneering a next-generation approach to treating diseases by degrading disease-causing mRNA. Its pioneering SAMiRNA™ platform has been instrumental in the creation of innovative drugs such as SRN-001, which holds immense promise in treating fibrotic diseases globally. With a firm commitment to research and innovation, siRNAgen continues to push the boundaries of scientific discovery to change the lives of patients worldwide.

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