US-based biopharmaceutical company Aardvark Therapeutics has announced positive results from three Phase II trials of ARD-101 for the treatment of obesity or other metabolic conditions.
ARD-101 is an oral small molecule bitter taste receptor (TAS2R) agonist.
The early findings show that ARD-101 demonstrated solid efficacy signals such as reductions in hunger and body fat composition in Prader-Willi Syndrome, a rare genetic condition characterised by incessant hunger and extreme overeating.
In the trial to treat Prader-Willi Syndrome, 11 of the 12 patients showed a decrease in hyperphagia in 28 days according to the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) assessment, with a seven-point average reduction and often beneficial changes to behaviour.
In addition, four of the patients experienced a near-complete resolution of hunger symptoms.
Aardvark Therapeutics said that in the general obesity trial, ARD-101 demonstrated a positive effect on hunger scores in the subjects.
The placebo-controlled trial included 20 subjects and used the Control of Eating Questionnaire (COEQ).
It found that patients who received ARD-101 experienced a 2.51 times greater reduction in hunger rating than those who were given placebo, with a p-value of 0.015.
Aardvark Therapeutics said that as part of the post-bariatric surgery trial, 11 subjects who continued to gain weight post-surgery were included.
Data from the open-label trial showed a consistent decrease in hunger scores and cravings for sweet and savoury foods.
In addition, ARD-101 showed increased weight control compared with placebo in obese patients.
The therapy did not show significant nausea or diarrhoea, which are both common among the existing GLP-1 drugs.
ARD-101 was also found to be safe and substantially gut-restricted in the trial.
Despite this, the therapy conveys systemic effects through the activation of gut peptide hormone secretion, including GLP-1, GLP-2 and cholecystokinin (CCK).
Founded in 2017, Aardvark Therapeutics aims to develop novel small-molecule therapeutics for the treatment of metabolic diseases, inflammation, and other indications.
