Aardvark Therapeutics (NasdaqGS:AARD) FY Conference Transcript

Aardvark Therapeutics FY Conference Summary Company Overview - Company: Aardvark Therapeutics (NasdaqGS:AARD) - Focus: Development of oral small molecule drugs targeting obesity and rare diseases, specifically Prader-Willi syndrome Core Product Information - Drug: ARD-101 - Mechanism: Activates gut-brain signaling via the vagus nerve, engaging GPCR on enteroendocrine cells to release gut peptide hormones that regulate hunger [6][11] - Formulation: Gut-restricted with minimal systemic absorption, designed to avoid taste perception [31] Product Variants - Single Agent: ARD-101 for rare diseases - Combination Agent: ARD-101 with Sitagliptin for general obesity - Sitagliptin: A DPP-4 inhibitor that prolongs the action of gut hormones, enhancing weight loss effects [7][12] Clinical Data and Trials - Phase 2 Study: - Results: 1.3 kg weight loss in obese patients over 28 days without diet/exercise [29][30] - Comparison: Semaglutide (2.4 mg) resulted in approximately 1.6 kg weight loss in a similar timeframe [29] - Preclinical Data: - Combination Therapy: 19% body weight loss in high-fat-fed mice within 30 days, comparable to Tirzepatide's 20.5% [21] - Upcoming Trials: - HERO Trial: Phase 3 trial for Prader-Willi syndrome, with top-line data expected in Q3 2026 [32] Primary Endpoint - Hunger Measurement: HQ-CT9 score, focusing on hyperphagia rather than weight loss as the primary outcome [33][34] Competitive Landscape - Competitor: ViCat (diazoxide choline) - Differentiation: Aardvark's drug does not have renal insufficiency exclusions and may improve insulin sensitivity [39] - Endpoint Similarity: Both drugs use the HQ-CT9 score for measuring hyperphagia [40] Additional Insights - Mechanistic Insights: The combination therapy is believed to invoke multiple gut peptide hormone releases, enhancing therapeutic benefits beyond single-agent effects [53] - Exploratory Endpoints: Addressing hyperanxiety, systemic inflammation, and gut transit issues in Prader-Willi patients [52] Conclusion - Aardvark Therapeutics is positioned to address significant unmet needs in obesity and rare diseases with its innovative drug formulations and ongoing clinical trials, showing promising early results and a clear differentiation strategy against competitors.