Arrowhead Pharmaceuticals, Inc. Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-RAGE for Treatment of Asthma
March 15, 2022 at 11:30 am
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Arrowhead Pharmaceuticals Inc. announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-RAGE, the company's investigational RNA interference therapeutic designed to reduce production of the receptor for advanced glycation end products (RAGE) as a potential treatment for asthma and other inflammatory pulmonary diseases. An application for approval of the clinical trial was 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 ARORAGE-1001, a Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-RAGE in up to 64 healthy volunteers and in up to 16 patients with asthma.
Arrowhead Pharmaceuticals, Inc. develops medicines that treat intractable diseases by silencing the genes that cause them. The Company's therapies, using a broad portfolio of ribonucleic acid (RNA) chemistries and modes of delivery, trigger the RNA interference (RNAi) mechanism to induce rapid, deep and durable knockdown of target genes. The Company's Targeted RNAi Molecule (TRiMTM) platform utilizes ligand-mediated delivery and is designed to enable tissue-specific targeting while being structurally simple. It is focused on various therapeutic areas, such as cardiometabolic, pulmonary, liver, muscle and central nervous system. It has around 14 clinical-stage investigational medicines (nine wholly owned and five partnered), which range in development stage from Phase I to Phase III. The Company's pipeline products include Plozasiran, Zodasiran, Olpasiran, ARO-RAGE, ARO-MUC5AC, ARO-MMP7, GSK-4532990, Fazirsiran, JNJ-3989, HZN-457, ARO-C3, ARO-PNPLA3, ARO-DUX4 and ARO-SOD1.