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Aardvark Therapeutics (AARD) investor relations material
Aardvark Therapeutics Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Technology overview
Oral small molecule drug is gut-restricted, activating gut-brain signaling via the vagus nerve to regulate hunger by inducing gut peptide hormone release through GPCR engagement on enteroendocrine cells.
Single agent (ARD-101) targets rare disease; combination with Sitagliptin is for general obesity, leveraging mechanistic rationale for both.
ARD-101 engages bitter taste receptors in the gut, stimulating hormone release that signals satiety to the brain.
Combination with Sitagliptin prolongs the activity of gut hormones by inhibiting DPP-4, enhancing anti-appetite effects.
Drug formulation avoids taste issues by releasing contents only in the gut.
Clinical data and development status
Monotherapy showed 1.3 kg weight loss over 28 days in a phase 2 obesity study without diet or exercise; comparable to Semaglutide's 1.6 kg in similar timeframe.
Combination therapy demonstrated 19% body weight loss in high-fat-fed mouse model, nearly matching Tirzepatide's 20.5%.
No clinical data yet for the combination in humans; the POWER trial will address this.
Phase 3 HERO trial in Prader-Willi syndrome began dosing in Q2 2024, with top-line data expected Q3 2026.
Competitive landscape and differentiation
ViCat (diazoxide choline) is a recent competitor, approved for hyperphagia but has exclusions for renal insufficiency and risk of hyperglycemia.
ARD-101 does not have renal exclusions and may improve insulin sensitivity, based on clinical and preclinical data.
Both drugs use the same HQ-CT9 endpoint for hyperphagia; even a one-point reduction is considered clinically meaningful.
ARD-101 is not mutually exclusive with ViCat and may be suitable for patients unable to tolerate ViCat.
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