Aardvark Therapeutics (AARD) Conference Call Summary Company Overview - Aardvark Therapeutics is a publicly traded company based in San Diego, California, focusing on developing oral small molecule drugs targeting bitter taste receptors to influence gut-brain signaling pathways related to hunger and appetite [2][3] Clinical Programs - The most advanced program is for Prader Willi syndrome, currently in a pivotal phase three trial with expected readout in early 2026 [4] - Plans to initiate a phase two program for hypothalamic obesity and advance another formulation, ARD 201, for general obesity [4][18] Drug Mechanism and Differentiation - Aardvark's drug targets hunger rather than appetite, differentiating it from GLP-1 drugs, which primarily suppress appetite [5][7] - The drug works through gut-brain pathways, reducing ghrelin levels, which is contrary to the effect of GLP-1 treatments that can increase ghrelin [8][20] - The company believes that CCK deficiency contributes to symptoms of Prader Willi syndrome and general obesity, which their drug aims to address [9] Clinical Data and Efficacy - In the phase two trial for Prader Willi syndrome, patients showed an average reduction of 30% in hyperphagia scores (HQCT) over a 28-day dosing period [12][14] - A subgroup of patients with similar features to those expected in the phase three trial experienced a 48% reduction in HQCT, indicating a high probability of success for the upcoming trial [15] - The drug has shown a favorable safety profile, with no adverse events exceeding grade two reported in over 70 patients dosed [11] Future Trials and Endpoints - The phase three trial will include a randomized, placebo-controlled design with primary endpoints focused on HQCT scores at week twelve [15][16] - Secondary endpoints will assess clinical global impression, body composition, inflammatory biomarkers, and ghrelin levels [16] Additional Programs - The hypothalamic obesity program is set to leverage similarities with Prader Willi syndrome, targeting patients with overactive hunger due to prior interventions [17] - The ARD 201 program aims to combine ARD 101 with a TPD4 inhibitor, enhancing its efficacy for general obesity while being cautious of its use in Prader Willi syndrome due to potential risks [18] Market Potential - There are approximately 10,000 to 25,000 patients in the U.S. with Prader Willi syndrome, with a global occurrence rate of 1 in 15,000 live births, suggesting a significant market opportunity [10] - The company aims to demonstrate additive benefits of their drug on top of existing GLP-1 therapies, potentially appealing to a broader patient population [20][22] Summary - Aardvark Therapeutics is strategically positioned with a unique approach to treating hunger-related conditions, backed by promising clinical data and a robust pipeline of programs targeting rare and general obesity [22]
Aardvark Therapeutics (AARD) 2025 Conference Transcript