Enrolment has begun in three Phase 2 studies of ARD-101, a first-in-class small molecule bitter taste receptor (TAS2R) pan-agonist. Two studies will evaluate ARD-101 in obesity and the other in refractory weight gain post-bariatric surgery. A third clinical trial will assess ARD-101 in patients with Prader-Willi Syndrome, a rare genetic disorder characterized by persistent hyperphagia. All three studies are designed to measure important aspects of metabolic syndrome to confirm the drug's activity and help design future clinical studies.
Aardvark Therapeutics’ lead product, ARD-101 is a first-in-class oral composition targeting extraoral bitter taste receptors (TAS2R). ARD-101 has shown promising activity in reducing appetite and promoting weight loss in pre-clinical studies. Phase 1 studies demonstrated safety and tolerability in healthy human volunteers and confirmed the drug was largely restricted to the gut while still inducing systemic effects, including increased expression of endogenous gut peptide hormones.
Ongoing Phase 2 studies will evaluate the drug's safety and efficacy in obesity and Prader-Willi Syndrome. Additional studies in metabolic and inflammatory disorders are in the planning stage.
The three phase 2 studies are based on the activity of ARD-101 demonstrated in animal models of obesity, diabetes, hyperlipidaemia and inflammation, and its favourable safety profile confirmed in a First-in-Human phase 1 trial completed last year.
The three study include:
ARD-101 in General obesity: A placebo-controlled, randomised, blinded study to evaluate the safety, tolerability and efficacy of oral ARD-101 in adults with BMI 30-45kg/m2. The study is being conducted at the University of California, San Diego (UCSD) and is planned to enrol 30 patients ages 18-75.
ARD-101 in Refractory Weight Gain Post-Bariatric Surgery: An open label phase 2 trial at UCSD and planned to enrol 30 patients ages 18-75 who experience relevant weight regain at least one year after sleeve gastrectomy or gastric bypass surgery.
ARD-101 in Prader-Willi Syndrome (PWS): An open label phase 2 trial being conducted at the Colorado Children's Hospital and Stanford Children's Health, California, is planned to enrol 12 patients ages 17-65.
“With a majority of adults in the US being either overweight or obese, and no approved treatments for PWS, clearly there is a need to develop new effective treatments. ARD-101 represents such a candidate therapy that has demonstrated safety and tolerability in studies to date and offers the convenience of oral administration,” said Aardvark Therapeutics CEO, Dr Tien Lee, commented: "We thank our collaborators for making it possible to initiate the first studies of ARD-101 in patients with hyperphagia and obesity. This therapy could represent a much-needed addition in the fight against obesity."