Arrowhead Files for Regulatory Clearance to Initiate Phase 1/2a Study of ARO-MMP7 for Idiopathic Pulmonary Fibrosis

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-MMP7, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce expression of matrix metalloproteinase 7 (MMP7) as a potential treatment for idiopathic pulmonary fibrosis (IPF).

James Hamilton, M.D., MBA, senior vice president of discovery and translational medicine at Arrowhead, said: “Arrowhead’s inhaled pulmonary TRiM^TM platform continues to generate compelling results in preclinical studies and promising drug candidates aimed at treating various diseases. ARO-MMP7 is a further expansion of our robust clinical pipeline, which also includes additional lung disease product candidates, ARO-RAGE and ARO-MUC5AC. MMP7 levels are a prognostic indicator in IPF, which is a progressive fibrotic disease characterized by a decline in lung function over time, and ARO-MMP7 offers a novel approach to potentially address the substantial unmet need in IPF.”

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 AROMMP7-1001, a Phase 1/2a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7 in up to 56 healthy volunteers and in up to 21 patients with IPF.

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

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Source: Arrowhead Pharmaceuticals, Inc.

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