Aardvark Therapeutics announces positive data from ARD-101 trials

The therapy demonstrated increased weight control compared with placebo in obese patients.

June 13 2023

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.

Uncover your next opportunity with expert reports

Steer your business strategy with key data and insights from our latest market research reports and company profiles. Not ready to buy? Start small by downloading a sample report first.

Newsletters by sectors

close

Sign up to the newsletter: In Brief

Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Thank you for subscribing

View all newsletters from across the GlobalData Media network.

close