BioAge Labs (BIOA) Jefferies London Healthcare Conference 2024 summary

Company overview and strategy

• Focuses on aging-related targets to address metabolic diseases, with a lead program azelaprag, an oral apelin receptor agonist in phase II trials combined with tirzepatide.

• Pipeline includes a CNS-penetrant NLRP3 inhibitor, with IND filing planned for the second half of next year, and additional early-stage programs from their aging-based discovery platform.

• Uses large human cohort data to identify targets linked to positive functional outcomes over decades of aging.

Lead program: azelaprag

• Azelaprag is a small molecule APJ agonist, designed to complement incretin-based therapies by increasing energy expenditure rather than suppressing appetite.

• Phase II trial, reading out in Q3 next year, aims to show a 3.3% incremental weight loss over tirzepatide alone at six months, using a low dose of tirzepatide to mimic oral GLP dynamics.

• Preclinical and clinical data suggest synergy with incretins, with potential for improved body composition and tolerability.

• Lilly is a collaborator, supplying tirzepatide and assisting in trial design and execution, and holds a soft right of first negotiation post-data readout.

• Exploratory endpoints in phase II include muscle, fat, bone composition, activity, and biomarkers, to inform future trials.

Clinical development and regulatory pathway

• Next steps include a potentially pivotal phase II/III trial combining azelaprag with semaglutide, aiming for an incretin-agnostic label.

• Regulatory approval requires a 5% incremental weight loss and 3,000 patient-years of exposure; phase II trials are sized for 90% power with 200-300 patients.

• Strategy includes both combination and monotherapy use, with a focus on induction and potential maintenance regimens.