The three phase 2 studies are based on the activity of ARD-101 demonstrated in animal models of obesity, diabetes, hyperlipidemia and inflammation, and its favorable safety profile confirmed in a First-in-Human phase 1 trial completed last year:
(1) ARD-101 in General obesity: A placebo-controlled, randomized, 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 enroll 30 patients ages 18-75. (For details see ClinicalTrials.Gov # NCT05121441).
(2) ARD-101 in Refractory Weight Gain Post-Bariatric Surgery: An open label phase 2 trial at UCSD and planned to enroll 30 patients ages 18-75 who experience relevant weight regain at least one year after sleeve gastrectomy or gastric bypass surgery (ClinicalTrial.Gov # NCT05215847) .
(3) 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 enroll 12 patients ages 17-65 (For details see ClinicalTrials.Gov # NCT05153434 ).
Aardvark Therapeutics CEO, Tien Lee, M.D., commented: "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. With a majority of adults in the U.S. 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". Dr. Lee added "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."
About ARD-101:
Aardvark's 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.
About Aardvark Therapeutics, Inc.:
A clinical stage biopharmaceutical company focused on developing novel small molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications. Founded in 2017, the company has now advanced ARD-101 to Phase 2.
For more information visit www.aardvarktherapeutics.com.
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SOURCE Aardvark Therapeutics, Inc.
