Aardvark Therapeutics has commenced subject enrolment in three Phase II clinical trials of its oral drug ARD-101. They are in obesity, in post-gastrectomy or gastric bypass surgery, and in Prader-Willi Syndrome.

A small-molecule bitter taste receptor (TAS2R) pan-agonist, ARD-101 demonstrated encouraging activity in lowering appetite and boosting weight loss in preclinical studies. 

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All three trials are intended to evaluate key aspects of metabolic syndrome in order to validate the activity of the drug and aid in designing trials in the future.

A placebo-controlled, randomised, blinded trial will analyse the safety, tolerability, and efficacy of ARD-101 for general obesity in adult subjects with body mass index (BMI) in the range of 30 to 45kg/m2. 

Another open-label Phase II trial will assess ARD-101 in subjects experiencing substantial weight regain a minimum of one year following sleeve gastrectomy or gastric bypass surgery.

Both these trials will be conducted at the University of California, San Diego (UCSD) and intend to enrol 30 subjects of the age 18 to 75 years.

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A third, open-label trial will analyse ARD-101 in 12 subjects with Prader-Willi Syndrome (PWS). It is being conducted at the Colorado Children’s Hospital and Stanford Children’s Health, California in the US and will have patients aged 17 to 65 years.

PWS is a rare genetic ailment characterised by persistent hyperphagia.

These trials are based on ARD-101’s activity shown in animal models of obesity, diabetes, hyperlipidemia and inflammation.

The oral drug also demonstrated a favourable safety profile in a first-in-human Phase I trial concluded last year.

Aardvark Therapeutics CEO Tien Lee said: “Our team at Aardvark is dedicated to developing novel therapies to address the global pandemic of metabolic disorders including obesity and diabetes which affects a rapidly growing population, while also addressing rare genetic disorders such as PWS that lead to significant quality of life impairment as well as life-threatening obesity in children. 

“ARD-101 represents such a candidate therapy that has demonstrated safety and tolerability in studies to date and offers the convenience of oral administration.”