Aardvark Therapeutics (AARD) Cantor Global Healthcare Conference 2025 summary

Company overview and scientific background

• Focuses on gut-restricted, oral small molecule drugs targeting gut-brain signaling to reduce hunger and appetite.

• Drug mechanism involves enteroendocrine cells in the gut, releasing peptide hormones that signal the brain via the vagus nerve.

• Targets both hunger (pain-avoidance) and appetite (pleasure-seeking) pathways, with particular relevance in Prader-Willi syndrome.

• Drug action is primarily local, avoiding super-physiologic hormone levels and associated side effects like nausea.

• Originated from observations on coffee's appetite-suppressing effects, theorizing the role of bitter taste receptors in the gut.

Preclinical and clinical data highlights

• Early placebo-controlled trial in general obesity showed a 1% greater weight loss and significant reduction in hunger scores with ARD-101.

• Ghrelin biomarker data supported the drug's mechanism, with effects enhanced by DPP-4 inhibitor sitagliptin.

• In a gold-standard diet-induced obesity mouse model, ARD-201 achieved 19% weight loss in 30 days, comparable to injectable GLP-1 drugs.

• Combination with micro-dose tirzepatide maintained or exceeded GLP-1-induced weight loss, preventing rapid weight regain.

Clinical development and trial updates

• Phase II program split into two studies: POWER (prevention of weight regain post-GLP-1) and STRENGTH (prospective weight loss study).

• POWER will enroll patients with ≥15% weight loss on GLP-1, using ARD-101 plus sitagliptin, starting by year-end; STRENGTH to begin in 1H 2026.

• POWER data readout expected in 2H 2026; STRENGTH readout guidance to be provided next quarter.

• Focus is on POWER due to strong commercial interest and potential for addressing weight regain, a key concern for partners.