Arrowhead Presents Additional Clinical Data on Investigational ARO-HSD Treatment at AASLD Liver Meeting
Arrowhead Pharmaceuticals (NASDAQ: ARWR) presented interim clinical data from its AROHSD1001 study at The Liver Meeting, showcasing ARO-HSD's potential for treating liver diseases like NASH. Key findings included a dose-dependent reduction in HSD17B13 mRNA, with over 90% reduction at 200 mg in all patients. Additionally, liver fat reductions were noted in 9 out of 18 patients. ARO-HSD was well-tolerated, with no serious adverse events linked to the drug. This investigational therapy aims to leverage RNA interference to combat liver diseases effectively.
- Over 90% reduction in hepatic HSD17B13 mRNA at 200 mg dose.
- Decreased liver fat in 9 of 18 patients (4-41% reductions).
- Well-tolerated with no serious adverse events related to ARO-HSD.
- None.
Key data presented include the following:
Pharmacodynamic Response
-
Dose-dependent pharmacodynamic effect on hepatic HSD17B13 mRNA was observed in all patients
-
At 200 mg, all patients showed greater than
90% mRNA reductions
-
At 200 mg, all patients showed greater than
- Hepatic HSD17B13 protein levels were reduced at all ARO-HSD dose levels, with multiple measurements below the assay’s lower limit of quantitation
- Decreases in ALT and AST were observed at doses of 100 mg ARO-HSD and greater
-
9 of 18 patients had liver fat reductions on MRI-PDFF of 4
-41% -
6 of 18 patients had reduction in liver stiffness (kPa) on FibroScan of 4
-37% -
Pharmacodynamic effect was not impacted by HSD17B13 (
rs72613567 , T>TA) or PNPLA3 (rs738409 , C>G) mutations
Safety
- ARO-HSD was well-tolerated in patients, with no ARO-HSD-related serious adverse events reported, no adverse events leading to drug discontinuations, and no ARO-HSD-related clinically significant adverse laboratory trends observed
- One treatment emergent serious adverse event of soft tissue injury that required hospitalization was reported in cohort 4b. This event was considered unrelated to study drug
A copy of the poster may be accessed on the Events and Presentations page under the Investors section of the Arrowhead website.
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
About
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 may contain 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 news 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,” “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. The forward-looking statements in this news release speak only as of the original date of this news release. 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, 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
Source:
________________
1
View source version on businesswire.com: https://www.businesswire.com/news/home/20211112005367/en/
626-304-3400
ir@arrowheadpharma.com
Investors:
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com
Media:
646-751-4361
jo@lifescicomms.com
www.lifescicommunications.com
Source:
FAQ
What is ARO-HSD being developed for?
What were the key findings from the AROHSD1001 study?
How well was ARO-HSD tolerated in the clinical trial?
Where were the ARO-HSD results presented?
What is the significance of the HSD17B13 mutation?
