Apelin receptor agonist BGE-105 trial will collect muscle aging biomarker data to inform Phase 2 trial design and future development for muscle atrophy in hospitalised patients.

BioAge Labs, a biotech company developing therapeutics that target the molecular causes of muscle aging to extend healthy human lifespan, has announced that the first cohort has been dosed in a Phase 1b trial of BGE-105, a highly selective and potent small-molecule agonist of the apelin receptor APJ.

Longevity.Technology: Muscle aging causes loss of strength, mobility and function among older people, while driving mortality and multiple age-related diseases and decreasing overall quality of life. It it no wonder, then, that BioAge is working on drugs that have the potential to address muscle aging and is looking to apelin, the natural ligand of the APJ receptor, which regulates multiple aspects of muscle metabolism, growth and repair.

BioAge’s AI-driven discovery platform, based on analysis of proprietary human aging cohort data, revealed that apelin protein levels decline with age and are strongly associated with longevity and preservation of muscle strength, identifying APJ as an attractive target for treating clinical indications related to muscle aging. BGE-105 binds APJ and mimics the activity of apelin.

“In aged mouse models, BGE-105 substantially rescued muscle atrophy due to limb immobilization, prevented loss of muscle function with age, and induced biomarkers of muscle regeneration,” said BioAge advisor William Evans, PhD, Adjunct Professor at UC Berkeley and Duke. “We believe that BGE-105 has the potential to prevent muscle atrophy and improve muscle function in older adults [1].”

The primary objective of BioAge’s randomised, placebo-controlled study is to evaluate the safety and tolerability of BGE-105 in healthy adults. Up to 72 healthy adult volunteers, at least half over the age of 50, will be enrolled. Multiple previous Phase 1 trials conducted by Amgen showed that oral or intravenous BGE-105 was safe and well-tolerated in 190 subjects, with no related serious adverse events reported.

In addition, the trial will characterise the pharmacokinetic (PK) and pharmacodynamic (PD) effects of BGE-105 and assess muscle parameters and relevant biomarkers as secondary endpoints.

“BGE-105 is a promising compound with the potential to address multiple severe indications driven by muscle aging, from acute hospital indications to chronic diseases,” said Kristen Fortney, PhD, CEO of BioAge. “Following completion of the Phase 1b trial, BioAge will proceed with a Phase 2 proof-of-concept trial of BGE-105 to improve recovery in patients with hospitalization-related muscle atrophy, an acute indication with high unmet medical need.”

In April 2021, BioAge entered into an exclusive worldwide licence agreement with Amgen to develop and commercialise BGE-105 to ameliorate muscle aging. The licence covers all indications, and BioAge is responsible for development, manufacturing and commercialisation of BGE-105 worldwide.