San Diego, CA, February 2, 2022 – Aardvark Therapeutics, Inc., a clinical stage biopharmaceutical company focused on developing novel small molecule therapeutics for the treatment of metabolic and inflammatory diseases, proudly announces the initiation of enrollment in three Phase 2 studies with the company’s lead drug ARD-101, a first-in-class small molecule bitter taste receptor (TAS2R) pan-agonist. All three studies are designed to measure important aspects of metabolic syndrome to confirm the drug’s activity and help design future clinical studies.
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:
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”.
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 a number 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.