Arrowhead Pharmaceuticals Enters Exclusive License Agreement with GSK for ARO-HSD
- Upon closing, Arrowhead to receive
- Arrowhead eligible to receive potential milestone payments and royalties on commercial sales
- GSK to receive an exclusive license for ARO-HSD in all territories except
“Genetic studies have shown that HSD17B13 is a compelling therapeutic target for multiple forms of liver disease. Based on the clinical results generated to date, including those recently presented at the 2021 AASLD Liver Meeting, ARO-HSD could have the potential to be the first investigational therapeutic to achieve robust reductions in mRNA and protein levels of hepatic HSD17B13, leading to reductions in ALT, a liver enzyme typically elevated in liver diseases such as NASH,” said
“NASH can be a life-threatening disorder in which excessive fat build-up in the liver causes inflammatory damage and fibrosis. The compelling genetic evidence linking HSD17B13 variants with protection of the liver from inflammatory injury suggests that there is an opportunity to produce a first-in-class medicine to reduce the clinical consequences of NASH. It’s exciting to advance Arrowhead’s promising RNAi approach into Phase 2 studies as an important potential new medicine for patients with NASH,” said
Under the terms of the agreement, Arrowhead will receive an upfront payment of
GSK will receive an exclusive license to develop and commercialize ARO-HSD in all territories except
The transaction is expected to close in the first quarter of 2022, subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
ARO-HSD is an investigational RNAi therapeutic targeting HSD17B13 as a potential treatment for patients with alcohol-related and nonalcohol related liver diseases, such as NASH. HSD17B13 is 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 ARO-HSD is being investigated in AROHSD1001 (NCT04202354), a Phase 1/2 single and multiple dose-escalating trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of ARO-HSD in up to 74 normal healthy volunteers and patients with NASH or suspected NASH. Additional exploratory objectives of AROHSD1001 include the assessment of various measures of drug activity using liver biopsy.
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