Arrowhead Pharmaceuticals Announces $30 Million Milestone Payment from GSK

Rhea-AI Summary

Arrowhead Pharmaceuticals (NASDAQ: ARWR) has achieved a $30 million milestone from GSK (LSE/NYSE: GSK) following the initiation of GSK4532990's Phase 2b trial for treating non-alcoholic steatohepatitis (NASH). This investigational RNA interference therapeutic was licensed to GSK in November 2021, with Arrowhead retaining rights for Greater China. The trial, known as HORIZON (NCT05583344), will assess the drug's efficacy and safety in up to 246 participants with pre-cirrhotic NASH. GSK4532990 targets HSD17B13, a gene linked to metabolic protection against NASH.

Positive

• Arrowhead received a $30 million milestone payment, enhancing its cash position.
• GSK4532990's Phase 2b trial marks a significant step in its development, advancing towards potential commercialization.

Negative

• None.

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it earned a $30 million milestone payment from GSK (LSE/NYSE: GSK) following the start of GSK’s Phase 2b trial of GSK4532990, formerly called ARO-HSD, an investigational RNA interference (RNAi) therapeutic for the treatment of patients with non-alcoholic steatohepatitis (NASH).

GSK4532990 is being developed under the November 2021 exclusive license agreement between Arrowhead and GSK. GSK received an exclusive license to develop and commercialize GSK4532990 in all territories except Greater China, which was retained by Arrowhead. GSK is wholly responsible for further clinical development and commercialization, outside of Greater China.

GSK4532990 targets HSD17B13, a member of the hydroxysteroid dehydrogenase family involved in the metabolism of hormones, fatty acids, and bile acids. Published human genetic data indicate that a loss of function mutation in HSD17B13 provides strong protection against alcoholic hepatitis, cirrhosis, and NASH, with approximately 30-50% risk reduction compared to non-carriers.¹

The double-blind, placebo-controlled Phase 2b HORIZON trial (NCT05583344) will evaluate the efficacy and safety of GSK4532990 in adults with pre-cirrhotic NASH. It will enroll up to 246 participants.

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.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

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,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology 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 forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. 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.

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References

1. The New England Journal of Medicine. 2018, 1096-1106

 

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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 milestone payment did Arrowhead Pharmaceuticals receive from GSK?

Arrowhead Pharmaceuticals received a $30 million milestone payment from GSK.

What is GSK4532990?

GSK4532990 is an investigational RNA interference therapeutic for treating non-alcoholic steatohepatitis (NASH).

When did GSK initiate the Phase 2b trial for GSK4532990?

The Phase 2b trial for GSK4532990 was initiated following the press release on April 3, 2024.

What company is involved in developing GSK4532990?

GSK is responsible for the development and commercialization of GSK4532990, under a licensing agreement with Arrowhead Pharmaceuticals.

How many participants will the Phase 2b trial for GSK4532990 enroll?

The Phase 2b trial will enroll up to 246 participants.