BioAge Announces Positive Topline Results for BGE-105 in Phase 1b Clinical Trial Evaluating Muscle Atrophy in Older Volunteers at Bed Rest
BioAge Labs, Inc. (“BioAge”), a clinical-stage biotechnology company developing therapeutics that target the molecular causes of aging to extend healthy human lifespan, today announced positive Phase 1b clinical data for BGE-105, a highly selective, potent, orally available small-molecule agonist of the apelin receptor APJ. BGE-105 treatment resulted in statistically significant prevention of muscle atrophy relative to placebo in healthy volunteers aged 65 or older after 10 days of strict bed rest.
Muscle atrophy—loss of muscle mass and strength—is a universal feature of human aging that increases the risk of multiple morbidities, shortens lifespan, and diminishes quality of life. Hospitalization and periods of forced inactivity greatly accelerate this loss in older people.
“The data from this Phase 1b study provide clinical validation of BioAge’s AI-driven discovery platform and demonstrate the power of our human-first approach to identify medically relevant drug targets,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “Our analysis of BioAge’s human aging cohorts revealed that the apelin pathway is a strong predictor of healthy longevity and muscle function, and now this has translated directly into our clinical finding that apelin pathway activation with BGE-105 improves muscle physiology in older adults. Today’s announcement is a milestone in BioAge’s mission to create a pipeline of drugs that treat disease and extend healthy lifespan by targeting the mechanisms of aging.”
BioAge’s analysis of proprietary human biobanks showed that apelin pathway activity, which declines with age, is positively associated with longevity, mobility, and cognitive function. Apelin, the natural ligand of APJ, is secreted by skeletal muscle in response to exercise and regulates multiple aspects of muscle metabolism, growth, and repair. BGE-105 binds APJ and activates apelin signaling. In April 2021, BioAge entered into an exclusive worldwide license agreement with Amgen, Inc. to develop and commercialize BGE-105 for all indications.
