BioAge Labs reported that its lead candidate, BGE‑102, a brain‑penetrant NLRP3 inhibitor, achieved strong safety and target engagement in a Phase 1 single‑ascending‑dose and multiple‑ascending‑dose study. Once‑daily doses of 60 mg and higher were well tolerated, with adverse events remaining infrequent and mild to moderate.
The study demonstrated 90‑98 % suppression of IL‑1β after 14 days of treatment, a key downstream marker of NLRP3 activation. In addition, 60 mg and higher doses exceeded the cerebrospinal fluid IC90 at Day 14, confirming robust central nervous system exposure and supporting the drug’s potential to address inflammation in both peripheral tissues and the brain.
BioAge plans to expand the Phase 1 program to include obese participants with elevated high‑sensitivity C‑reactive protein. Data from these new cohorts are expected in the first half of 2026, marking the next step toward evaluating BGE‑102’s clinical efficacy in the obesity population.
Financially, BioAge reported Q3 2025 collaboration revenue of $2.1 million and a net loss of $20.2 million. The company’s cash, cash equivalents, and marketable securities stood at approximately $295.9 million, providing a runway through 2029. The discontinuation of the azelaprag Phase 2 trial in December 2024, due to liver side effects, had previously weighed on investor sentiment, making the current positive data a significant turnaround.
Market reaction to the announcement was positive, reflecting investor confidence in the drug’s safety profile, target engagement, and brain‑penetrant properties.
CEO Kristen Fortney said, “These interim results reinforce BGE‑102’s best‑in‑class potential and validate our strategy to target NLRP3‑driven inflammation in metabolic and cardiovascular disease.”
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