BioAge Labs has dosed the first subject in the randomised Phase I study of BGE-102, an orally available small molecule designed to inhibit NLRP3 and is under development initially for treating obesity.
The placebo-controlled, double-blind study intends to assess the tolerability, safety, pharmacodynamics (PD) and pharmacokinetics (PK) of the therapy in healthy individuals.
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The first part of the trial will test single ascending doses (SAD), while the second part will focus on multiple ascending doses (MAD) taken once a day over 14 days.
It aims to determine the PK profile characteristics of BGE-102 through blood samples, gauge its ability to penetrate the central nervous system via cerebrospinal fluid sampling, and measure its PD effects with an ex vivo whole blood stimulation assay that quantifies the compound’s capacity to curb the production of inflammatory signals like IL-1β.
BioAge noted that NLRP3 plays a significant role in inflammation related to age.
Analysis of human ageing cohorts by the company’s discovery platform highlighted NLRP3 as a potential therapeutic target, noting that decreased activity correlates with increased longevity.
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By GlobalDataBGE-102 is said to have shown high potency suitable for once-daily dosing and significant brain penetration, suggesting it could tackle neuroinflammation, which affects appetite regulation, and systemic inflammation linked to cardiovascular risk and obesity.
The compound has also exhibited a robust safety profile in studies for GLP toxicology without adverse effects.
BioAge co-founder and CEO Kristen Fortney said: “By inhibiting NLRP3-driven inflammation, a core driver of metabolic dysfunction, BGE-102 has the potential to complement existing therapies like GLP-1 agonists to enhance weight loss and curb excess inflammation.
“We believe that with convenient once-daily oral dosing and exceptional brain penetration, BGE-102 is positioned to tackle neuroinflammation in obesity and related conditions, offering versatility as a standalone or combination option.”
Upon completing the Phase I trial, with initial SAD data expected by the end of this year, the company plans to progress the therapy into a proof-of-concept trial for obesity in 2026, with top-line data anticipated by this year’s end.
Last year, BioAge Labs halted the Phase II STRIDES study of azelaprag, both as a standalone treatment and in combination with tirzepatide, due to cases of liver transaminitis observed in some patients.
