Aardvark Therapeutics (AARD) RBC Capital Markets Global Healthcare Conference 2025 summary

ARD-101 mechanism and differentiation

• ARD-101 targets bitter taste receptors in the gut, stimulating natural release of hormones like CCK, GLP-1, GLP-2, and likely PYY, which regulate hunger and appetite without systemic exposure.

• The approach differs from GLP-1s by reducing hunger without making food unappealing, allowing for easier adherence to diets.

• Unlike exogenous CCK analogs, ARD-101 avoids toxicity by stimulating only natural, rapidly degraded hormone levels.

Prader-Willi syndrome focus and market landscape

• Prader-Willi syndrome is characterized by severe hyperphagia, causing significant family and patient burden.

• Recent approval of Soleno's DCCR offers some benefit but has side effects and limited efficacy, leaving unmet need.

• ARD-101 aims to address the root cause of hyperphagia and is positioned to potentially replace DCCR in the market.

Clinical trial data and design evolution

• Phase II studies showed a robust nine-point drop in HQ-CT hyperphagia scores over 28 days, with anecdotal reports of greater efficacy.

• Dose escalation studies confirmed safety and consistent efficacy, leading to higher dosing in Phase III.

• Phase III design includes stricter entry criteria, exclusion of patients on appetite-stimulating antipsychotics, and measures to minimize placebo response.

• Powering targets a five-point HQ-CT change with 90% power, enrolling 45 patients per arm, and interim analysis for adjustments.