Arrowhead Pharmaceuticals Presents Preclinical Data on New RNAi-Based Obesity Program ARO-INHBE
Arrowhead Pharmaceuticals (NASDAQ: ARWR) unveiled preclinical data on its RNAi-based obesity program, ARO-INHBE, at the ADA 84th Scientific Sessions. The data demonstrated that ARO-INHBE significantly reduced hepatic INHBE gene expression, which is linked to decreased abdominal fat and improved metabolic profiles. Promising results showed a 95% reduction in INHBE mRNA expression, 19% suppression of body weight, 26% fat mass loss, and preservation of lean mass in obese and diabetic mouse models. Regulatory clearance for clinical trials is planned for late 2024. Co-treatment with tirzepatide and INHBE siRNA indicated potential dose reduction benefits without losing therapeutic efficacy. Arrowhead's pipeline, including ongoing Phase 3 trial results and preclinical programs, will be discussed in upcoming R&D webinars in June and August 2024.
- ARO-INHBE achieved 95% reduction in INHBE mRNA expression.
- Preclinical trials showed 19% suppression of body weight.
- Results indicated a 26% loss of fat mass and preservation of lean mass.
- Co-treatment with tirzepatide and INHBE siRNA could reduce tirzepatide dosage without compromising effectiveness.
- Regulatory clearance for clinical trials is planned for late 2024.
- None.
Insights
The preclinical data for ARO-INHBE, an investigational RNAi-based medicine, signals an important step forward in developing new therapies for obesity and metabolic diseases. The ability to silence the INHBE gene and reduce body weight while preserving lean mass is noteworthy. This novel approach targets a genetic pathway previously identified as having beneficial effects on fat reduction and metabolic health, offering potential advantages over existing treatments that can have significant side effects such as loss of lean mass and gastrointestinal issues. This data could pave the way for a new class of obesity treatments that are both effective and have a better side effect profile.
The market implications for Arrowhead Pharmaceuticals are substantial given the promising preclinical data for ARO-INHBE. The obesity drug market is highly competitive and lucrative, with significant opportunities for growth. If future clinical trials confirm these results, Arrowhead could capture significant market share. Moreover, the successful combination of INHBE siRNA with a lower dose of tirzepatide may offer a competitive edge by potentially enhancing the efficacy of existing treatments while reducing their adverse effects. This could make Arrowhead's pipeline attractive to both investors and potential partners or acquirers in the pharmaceutical industry.
From a financial perspective, the announcement of these preclinical results is a positive indicator for Arrowhead Pharmaceuticals. The potential of ARO-INHBE to become a novel therapeutic for metabolic disease positions the company well for future growth. Regulatory clearance plans for late 2024 suggest a clear roadmap for advancing this candidate into clinical trials. Investors should, however, remain cautious as preclinical success does not always translate to clinical efficacy. Nevertheless, the data supports a potentially strong future revenue stream, particularly if ARO-INHBE can be commercialized successfully.
The preclinical results demonstrate that ARO-INHBE substantially silenced hepatic expression of the INHBE gene, which has been identified through large genetic studies as a promising target for next generation therapies to address obesity and metabolic diseases. Further, Arrowhead’s preclinical research suggests that INHBE knockdown may potentially lead to a suppression in body weight gain, loss of fat mass, and preservation of lean mass. Arrowhead plans to file for regulatory clearance in late 2024 to begin clinical studies of ARO-INHBE.
“There has been a great deal of progress with new agents to treat obesity and metabolic diseases, but significant loss of lean mass and adverse gastrointestinal events at higher dose levels have necessitated the identification of new therapeutic strategies with novel mechanisms of action,” said James Hamilton, M.D., chief of discovery and translational medicine at Arrowhead. “ARO-INHBE directly targets hepatic expression of the INHBE gene. Prior genetic studies have associated loss of function mutations in the INHBE gene with reduced levels of abdominal fat and an improved metabolic profile. Our preclinical data presented at ADA suggest that INHBE reduction with siRNA is a promising new approach to address obesity and metabolic diseases and strongly support advancing ARO-INHBE into clinical trials.”
In pharmacological studies in obese and diabetic mouse models, INHBE siRNA administration resulted in multiple promising findings, including the following:
-
95% reduction in INHBE mRNA expression -
19% suppression of body weight compared to saline controls -
26% loss of fat mass - Preservation of lean mass
In addition, co-treatment of tirzepatide with INHBE siRNA allowed for the use of a lower tirzepatide dose without compromising its therapeutic effect. These encouraging results suggest that ARO-INHBE has the potential to be a novel therapeutic for metabolic disease.
Details about the ADA presentations are listed below.
American Diabetes Association 84th Scientific Sessions – June 21-24, 2024
Title: Liver-specific silencing of INHBE with ARO-INHBE, an siRNA therapeutic, for metabolic diseases
Date: June 24, 2024
Type: Poster
Arrowhead will discuss its growing pipeline of cardiometabolic medicines at two events as part of its 2024 Summer Series of R&D Webinars. The company’s lead clinical programs, including the recently completed PALISADE Phase 3 study in familial chylomicronemia with plozasiran, will be highlighted on June 25, 2024, and two preclinical programs addressing obesity and metabolic diseases, including ARO-INHBE, will be discussed on August 15, 2024.
The ADA presentation and the Summer Series of R&D Webinars may be accessed on the Events and Presentations page in the Investors section of the Arrowhead website.
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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Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
LifeSci Communications, LLC
Kendy Guarinoni, Ph.D.
724-910-9389
kguarinoni@lifescicomms.com
Source: Arrowhead Pharmaceuticals, Inc.
FAQ
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