Arrowhead Files for Regulatory Clearance to Begin Phase 1/2a Study of ARO-C3 for Treatment of Complement Mediated Diseases

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[{"type":"text","content":"\n- KOL Webinar Tomorrow, October 26, 2021 at 3:00 p.m. ET\n\n PASADENA, Calif.--(BUSINESS WIRE)--\nArrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to begin a Phase 1/2a clinical trial of ARO-C3, the company’s investigational RNA interference (RNAi) therapeutic being developed as a treatment for patients with various complement mediated diseases. Arrowhead will host a key opinion leader (KOL) webinar on October 26, 2021, at 3:00 p.m. ET to discuss ARO-C3 and the company’s development plans.\n\nChris Anzalone, Ph.D., president and chief executive officer of Arrowhead, said: “ARO-C3 utilizes Arrowhead’s proprietary TRiM™ platform to silence the hepatic production of complement C3. This will be our tenth TRiM™-enabled clinical program and the eighth targeting a liver expressed protein. In all of our liver-targeted programs to date, we have seen consistent and efficient translation of preclinical in vivo results to human clinical results, so we have a high degree of confidence in investigational ARO-C3. In addition, we view ARO-C3 as having the potential to address multiple serious complement-mediated or complement-associated diseases with unmet need in the renal and hematology space. We look forward to discussing the program in more detail on October 26, 2021 when we host a webinar, during which key opinion leaders will describe some of the diseases that may potentially be addressed by ARO-C3. These include IgA nephropathy, C3 glomerulopathy, and paroxysmal nocturnal hemoglobinuria.”\n\nAn application for approval of the clinical trial is being submitted to a local Ethics Committee and to the New Zealand Medicines and Medical Devices Safety Authority for review by the Standing Committee on Therapeutic Trials. Pending clearance, Arrowhead intends to proceed with AROC3-1001, a Phase 1/2a dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 24 adult healthy volunteers and in up to 24 adult patients with paroxysmal nocturnal hemoglobinuria and up to 14 adult patients with complement-mediated renal disease.\n\nThe webinar will feature presentations by KOLs Richard J. Glassock, MD, MACP, FRCP, FASN (David Geffen School of Medicine at UCLA), and Peter Browett, BMedSci, MBChB, FRACP, FRCPA (University of Auckland Sc...

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