US-based pharmaceutical company Arrowhead Pharmaceuticals has applied to launch a Phase I/IIa clinical trial of ARO-INHBE, an investigational RNA interference (RNAi) therapy for treating obesity, in New Zealand.
The company’s application was submitted to the New Zealand Medicines and Medical Devices Safety Authority and will be reviewed by the Standing Committee on Therapeutic Trials.
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The AROINHBE-1001 dose-escalation study is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-INHBE.
It will involve up to 78 adult diabetic and non-diabetic subjects with obesity.
In the trial’s first portion, single and multiple doses of ARO-INHBE will be assessed as a standalone treatment, while the second portion will evaluate its combination with tirzepatide.
Tirzepatide is a medication currently approved for managing type 2 diabetes (T2D) and weight control.
ARO-INHBE is designed to suppress the expression of the INHBE gene in the liver, which in turn reduces the secretion of Activin E, a gene product involved in regulating energy balance in fat tissue.
Loss-of-function variants in the INHBE gene are claimed to be linked to a lower risk of obesity and metabolic conditions such as T2D.
Arrowhead Discovery and Translational Medicine chief James Hamilton said: “Arrowhead’s two investigational RNAi therapies for the treatment of obesity, ARO-INHBE and ARO-ALK7, are both designed to intervene in the same pathway that signals the body to store fat in adipose tissue.
“We believe new therapeutic strategies with novel mechanisms of action, like ARO-INHBE and ARO-ALK7, have the potential to make a significant impact on the way obesity is treated and we are eager to initiate clinical studies of these important new programmes.”
Arrowhead Pharmaceuticals plans to seek regulatory approval for another obesity candidate, ARO-ALK7, before the end of this year.
Last month, the company announced plans to advance ARO-INHBE and ARO-ALK7 into the clinical trial development stage.
