Biotech company BioAge Labs has announced plans to initiate a Phase 2 trial of an orally administered treatment for obesity.
The Phase 2 trial will examine the efficacy of BioAge Labs’ oral apelin receptor agonist BGE-105 (azelaprag) co-administered with the GLP-1/GIP receptor agonist tirzepatide for the treatment of obesity. The trial is expected to start in mid-2024.
The primary endpoint of the Phase 2 trial will be total weight loss, with related secondary endpoints to characterise additional potential benefits of the mechanism. BioAge will also collect ageing-related biomarkers from the participants.
“Our Phase 2 trial is designed to assess whether azelaprag can substantially increase the weight loss achieved with drugs of the incretin class,” said Kristen Fortney, CEO and co-founder of BioAge. “This combination could enhance the performance of both injectable and oral incretin drugs, the company said.
“The oral route of administration of azelaprag makes it particularly exciting as a combination partner for next-generation oral incretins currently in development. As an additional benefit, azelaprag may help promote healthier weight loss. Treating obesity has the potential to prevent or delay multiple diseases of aging and increase healthspan for a large segment of the population.”
In preclinical studies, co-administration of azelaprag and tirzepatide to diet-induced obese mice increased total weight loss achieved on tirzepatide alone, normalised body composition to levels observed in lean controls and decreased fed glucose levels without an observable decrease in calorie intake.
Azelaprag mimics the activity of apelin, an “exerkine” peptide that is released in response to exercise. Apelin acts on skeletal muscle, heart and central nervous system to regulate metabolism and promote muscle regeneration. Apelin signalling has demonstrated multiple benefits in energy metabolism in mouse models, including increased insulin sensitivity and reduction in fat mass.
In December 2022, BioAge announced positive topline results from a Phase 1b clinical trial showing that azelaprag treatment resulted in statistically significant prevention of muscle atrophy and maintenance of muscle protein synthesis in healthy volunteers aged 65 or older after 10 days of strict bed rest.
Chorus, a clinical development organisation within Eli Lilly and Company will advise and assist BioAge on all aspects of the Phase 2 trial design and execution. As part of the collaboration, Lilly will also provide BioAge with tirzepatide.
“We are thrilled to work directly with the clinical development experts at Chorus and benefit from Lilly’s expertise in obesity drug development,” said Fortney.
“Lilly is committed to enabling the biotech ecosystem by catalyzing breakthrough science,” Nisha Nanda, group VP of external innovation at Lilly added.
“We are creating access to a suite of capabilities aimed at removing barriers to innovation such as our ‘one stop shop’ candidate to clinical Proof of Concept development unit Chorus. We are excited about the opportunity to collaborate with BioAge to share Lilly’s expertise in incretins, and utilize our Chorus clinical development engine to continue to advance the science to treat cardiometabolic diseases, like obesity.”
