, Inc. (NASDAQ:ARWR) on Tuesday shared interim results from two Phase 1/2a trials of ARO-INHBE and ARO-ALK7, the company’s investigational RNA interference (RNAi) therapeutics for obesity.
Preliminary results showed meaningful reductions in multiple key measures, including visceral fat, total fat, and liver fat.
What Is ARO-INHBE and ARO-ALK7 Therapy?
Unlike current GLP-1 drugs (like Wegovy or Zepbound) that primarily reduce appetite, these candidates aim to change how the body stores and burns fat by silencing specific genetic pathways.
Their primary goal is to promote weight loss while preserving lean muscle mass, a common side effect of existing weight-loss medications.
The Phase 1/2a studies of ARO-INHBE and ARO-ALK7 are ongoing, and the company expects to report and present additional results in 2026.
Arrowhead, in a press release on Tuesday, said the interim results represent the first demonstration in humans of the Activin E/ALK7 pathway, a genetically validated pathway that regulates adipose fat storage.
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Select ARO-INHBE Phase 1/2a Data:
In combination with Eli Lilly and Co.’s (NYSE:LLY) tirzepatide (Mounjaro/Zepbound), ARO-INHBE has doubled weight loss and tripled reductions in visceral fat, total fat, and liver fat versus tirzepatide alone in obese patients with type 2 diabetes mellitus.
A single dose of ARO-INHBE in adult volunteers with obesity (n=4 per dose level) achieved a dose-dependent reduction in serum Activin E with a mean maximum reduction of -85% after a single 400 mg dose and a maximum observed reduction of -94%.
Single dose ARO-INHBE monotherapy at week 16 led to:
- Mean visceral fat reduction of -9.9%
- Mean liver fat relative reduction of -38%
- Increased total lean tissue of 3.6%
Two doses of ARO-INHBE monotherapy at Week 24 achieved a mean visceral fat reduction of -15.6%, adjusted for placebo.
Two doses of ARO-INHBE (400 mg) in combination with tirzepatide (n=4) achieved approximately two-fold weight loss at week 16 and an approximately three-fold reduction in fat.
ARO-INHBE has been generally well tolerated to date as monotherapy and in combination with tirzepatide.
Select ARO-ALK7 Phase 1/2a Results
The company said ARO-ALK7 is the first RNAi-therapeutic to show adipocyte gene target silencing in a clinical trial.
ARO-ALK7 achieved dose-dependent reductions in adipose ALK7 mRNA with a mean reduction of -88% at the 200 mg dose at week 8, with a maximum reduction of -94% (n = 4).
In addition, a single dose of ARO-ALK7 led to rapid dose-dependent reductions in mean visceral fat with a -14.1% reduction, adjusted for placebo, already observed at Week 8.
ARO-ALK7 has been generally well-tolerated to date as monotherapy.
ARWR Price Action: Arrowhead Pharma shares were up 17.81% at $75.26 at the time of publication on Tuesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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