BioAge Labs, Inc. (Nasdaq: BIOA) announces positive interim data from the ongoing Phase 1 clinical trial of BGE-102, a promising NLRP3 inhibitor targeting inflammation in patients with cardiovascular risk factors.
The study shows that BGE-102 was well-tolerated and achieved high brain penetration, demonstrating its potential effectiveness in targeting NLRP3-driven inflammation.
The Phase 1 trial's safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 provide promising initial findings for its further development.
Safety & Tolerability
BGE-102 demonstrated good tolerability and safety across all dose levels evaluated in the trial.
Pharmacokinetics & Pharmacodynamics
The drug exhibited dose proportionality, achieved significant suppression of IL-1β, and showed high brain penetration, setting it apart from other inhibitors.
CNS Penetration
BGE-102 doses of 60 mg and higher achieved concentrations exceeding the IC90 in the cerebrospinal fluid, indicating strong central nervous system penetration.
Phase 1 Study Design
The randomized, double-blind Phase 1 trial in healthy volunteers and obese participants evaluated SAD and MAD cohorts, with an expansion to include obese participants with elevated hsCRP.
Anticipated Milestones
Expected milestones include completion of Phase 1 MAD cohorts, initiation of Phase 2a study in obesity and cardiovascular patients, and Phase 2a data readout in the second half of 2026.
- The positive interim data from BioAge's Phase 1 trial suggest promising prospects for BGE-102 as a potential treatment for patients with cardiovascular risk factors.
- The drug's safety profile, strong target engagement, and high brain penetration indicate its potential as a best-in-class NLRP3 inhibitor in targeting inflammation across central and peripheral tissues.
The encouraging results from the Phase 1 trial of BGE-102 highlight its potential as a novel therapeutic option for addressing inflammation in patients with cardiovascular risk factors. BioAge's ongoing research and upcoming milestones point to a promising future for BGE-102 development in metabolic diseases.