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

Rhea-AI Summary

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has submitted an application to commence a Phase 1/2a clinical trial for ARO-MMP7, an investigational RNA interference therapeutic targeting matrix metalloproteinase 7 (MMP7) for idiopathic pulmonary fibrosis (IPF). The trial aims to assess safety, tolerability, and pharmacokinetics in healthy volunteers and IPF patients. This initiative expands Arrowhead's clinical pipeline, which includes other lung disease candidates. The trial approval is pending from the local Ethics Committee and the New Zealand Medicines and Medical Devices Safety Authority.

Positive

• Filed application for Phase 1/2a trial of ARO-MMP7 targeting MMP7 for IPF.
• Expands Arrowhead's clinical pipeline including ARO-RAGE and ARO-MUC5AC.
• MMP7 is a significant prognostic biomarker in idiopathic pulmonary fibrosis.

Negative

• None.

PASADENA, Calif.--(BUSINESS WIRE)-- 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.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

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This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” or “continue” are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220817005085/en/

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

ir@arrowheadpharma.com

Investors:

LifeSci Advisors, LLC

Brian Ritchie

212-915-2578

britchie@lifesciadvisors.com

www.lifesciadvisors.com

Media:

LifeSci Communications, LLC

Josephine Belluardo, Ph.D.

646-751-4361

jo@lifescicomms.com

www.lifescicommunications.com

Source: Arrowhead Pharmaceuticals, Inc.

FAQ

What is the purpose of Arrowhead's Phase 1/2a clinical trial for ARO-MMP7?

The trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-MMP7 in treating idiopathic pulmonary fibrosis (IPF).

What is ARO-MMP7 designed to do?

ARO-MMP7 is an RNA interference therapeutic aimed at reducing matrix metalloproteinase 7 (MMP7) levels, which are linked to the progression of IPF.

When was the application for the ARO-MMP7 trial filed?

The application for the ARO-MMP7 Phase 1/2a clinical trial was announced on the date of the press release.

What is Arrowhead Pharmaceuticals' stock symbol?

Arrowhead Pharmaceuticals trades under the stock symbol ARWR on the NASDAQ.

What are the next steps after the trial application submission?

Arrowhead Pharmaceuticals plans to proceed with the clinical trial pending approval from the Ethics Committee and the New Zealand Medicines and Medical Devices Safety Authority.