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Aardvark Therapeutics, a clinical-stage biopharmaceutical company, is developing novel, small-molecule therapies designed to suppress hunger for the potential treatment of Prader-Willi Syndrome and metabolic diseases.
Glucagon-like peptide-1 (GLP-1) based drugs are effective therapies for obesity, but >50% of patients stop taking them within 3 months, which can result in rapid weight regain and loss of metabolic benefits.1,2
New alternative therapies that improve upon long-term benefits, safety and tolerability, and sustainable outcomes.
While GLP-1s work via a systemic approach to suppress appetite, Aardvark is targeting the gut-brain axis to control both hunger and appetite.
We are developing compounds designed to activate taste 2 receptors (TAS2Rs), which are thought to play a key role in gut-brain signaling. When activated, TAS2Rs expressed on gastrointestinal enteroendocrine cells modulate the release of gut-derived peptide hormones involved in the satiation of both hunger and appetite.
Our novel oral formulation of the TAS2R agonist denatonium acetate monohydrate (DA), called ARD-101, is designed to deliver DA directly to the gastrointestinal tract.
ARD-101 is largely restricted to the gut (>99%), which is thought to minimize systemic exposure.
ARD-201 is planned to be a fixed-dose combination of the TAS2R agonist ARD-101 and the DPP-4 inhibitor sitagliptin.
DPP-4 inhibitors extend the biological activity of gut hormones involved in satiety. Together, TAS2R agonists + DPP-4 inhibitors may enhance and prolong the body’s natural signals for fullness.
Aardvark's compounds are investigational. The safety and efficacy have not been established.
See the Phase 2 study results of ARD-101 as well as insights from preclinical studies investigating the impact of ARD-201 on weight gain in diet-induced obese (DIO) mice.
Aardvark's compounds are investigational. The safety and efficacy have not been established.
We are advancing ARD-201 into two upcoming Phase 2 clinical studies:
Evaluating ARD-201 for the potential to prevent weight regain in subjects who discontinue GLP-1RA therapy.
Exploring placebo-adjusted weight loss of ARD-201 alone and the additive effects of ARD-201 combined with GLP-1RA therapy.
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REFERENCES: 1. Real-World Trends in GLP-1 Treatment Persistence and Prescribing for Weight Management Blue Health Intelligence, Issue Brief May 2024. 2. Withdrawal of Semaglutide: The STEP 1 Trial Extension. Diabetes Obes Metab. 2022;24:1553-1564.
