Aardvark Therapeutics (AARD) 2025 Conference Transcript

Aardvark Therapeutics (AARD) 2025 Conference Summary Company Overview - Aardvark Therapeutics is a San Diego-based biotech company focused on small molecule drug development, specifically targeting gut-brain signaling pathways to mediate appetite regulation [3][4] Core Points and Arguments Drug Mechanism and Development - Aardvark's drug is a gut-restricted small molecule that signals the gut-brain pathway to reduce hunger by affecting enteroendocrine cells, which release gut peptide hormones [3][4][5] - The primary mechanism of action is believed to be through the vagal nerve, which communicates with the brain to regulate appetite [5][6] - The drug targets both hunger and appetite, with recent preclinical data showing effectiveness in general obesity beyond just Prader Willi syndrome [8][9][10] Clinical Trials and Results - Aardvark conducted a placebo-controlled trial with 20 patients for general obesity, showing a 1% greater weight loss in the treatment group compared to placebo [14] - Significant reductions in subjective hunger scores and ghrelin levels were observed, indicating the drug's effectiveness in appetite regulation [15] - In a diet-induced obesity mouse model, the ARD201 formulation resulted in a 19% weight loss over 30 days, comparable to the 20.5% weight loss seen with tirzepatide [22][23] Upcoming Trials - Aardvark is amending its Phase II program to focus on two new studies: the POWER trial (Prevention of Weight Regain) and the STRENGTH trial, both set to start before the end of 2025 [25][27] - The POWER trial will recruit patients who have lost at least 15% of their weight on GLP-1s, while the STRENGTH trial will compare the combination of Aardvark's drug with GLP-1s [27][30] Patient Population and Inclusion Criteria - The company plans to lower the age inclusion criteria for the Prader Willi program to potentially include patients as young as seven years old, aiming for a broader label if successful [42][44] - Recent updates allow for patients on concomitant atypical antipsychotics to participate, addressing previous concerns about trial purity [45][47] Market Position and Competitive Landscape - Aardvark anticipates competition from drugs like VICAD XR but believes its drug's side effect profile and early data will attract patient interest [59][60] - The company is focused on maintaining a strong enrollment rate for its trials despite the competitive landscape [60] Other Important Content - The drug's mechanism is designed to enhance the natural secretion of gut peptide hormones without reaching super-physiological levels, potentially reducing side effects like nausea [18][19] - Aardvark's approach to managing placebo effects includes a second baseline score assessment to ensure accurate measurement of treatment effects [52] - The company plans to share peer-reviewed publications and updates on trial progress over the next 12 to 18 months, with a presence at ObesityWeek in November [66]