BioAge Labs (BIOA) Study result summary

Phase I study design and objectives

• Phase I was a randomized, double-blind, placebo-controlled trial in healthy and obese subjects with elevated inflammation, assessing safety, pharmacokinetics, and pharmacodynamics, focusing on inflammatory biomarkers like hs-CRP.

• Obese cohorts were chosen to mirror the target population for future cardiovascular studies.

• Doses tested included 60 mg and 120 mg for up to 21 days, with baseline CRP levels elevated above 3 mg/L.

• Primary endpoints included pharmacokinetics and safety; exploratory endpoints assessed inflammatory biomarkers.

Key efficacy and biomarker results

• Both 60 mg and 120 mg doses achieved up to 86% median CRP reduction in obese subjects, with 87%-93% of patients reaching CRP below 2 mg/L.

• Over 90% inhibition of IL-1β at both 60 mg and 120 mg doses, with consistent 24-hour target coverage.

• IL-6 reductions were up to 78% (60 mg) and 69% (120 mg) at Day 7; fibrinogen reductions up to 23% (60 mg) and 30% (120 mg).

• Drug demonstrated strong CNS and ocular penetration, enabling potential for neuroinflammation and ophthalmology indications.

Safety and tolerability

• BGE-102 was well tolerated at all dose levels, with only mild to moderate, self-limited adverse events and no serious adverse events or discontinuations.

• No neutropenia, thrombocytopenia, or infections observed; adverse event rates were similar to placebo.

• No clinically meaningful changes in vital signs, ECGs, or labs.

• Headaches were mostly attributed to lumbar punctures, not drug-related, with no dose group differences.