Home/Filings/8-K/0001193125-26-009911
8-K//Current report

BioAge Labs, Inc. 8-K

Accession 0001193125-26-009911

$BIOACIK 0001709941operating

Filed

Jan 11, 7:00 PM ET

Accepted

Jan 12, 9:10 AM ET

Size

339.7 KB

Accession

0001193125-26-009911

Research Summary

AI-generated summary of this filing

Updated

BioAge Labs Announces Positive Phase 1 Data for BGE-102

What Happened
On January 12, 2026 BioAge Labs (BIOA) announced additional interim Phase 1 data for BGE-102, a brain‑penetrant NLRP3 inhibitor. The company completed the first multiple ascending dose (MAD) cohort in obese participants with elevated hsCRP who received 120 mg once daily (QD) and reported rapid, large reductions in inflammatory biomarkers. A press release was attached to the 8‑K (Exhibit 99.1).

Key Details

  • BGE-102 produced an 86% reduction in hsCRP by Day 14; 93% of participants reached normalized hsCRP (<2 mg/L).
  • Significant reductions were also seen in IL‑6 and fibrinogen, both linked to systemic inflammation and cardiovascular risk.
  • Dosing in the reported cohort: 120 mg QD; safety: BGE-102 was reported as well tolerated with a favorable safety profile.
  • Intellectual property: a patent issued covering additional composition of matter and a novel NLRP3 binding site.
  • Planned milestones and timeline: complete Phase 1 with two additional MAD cohorts (1H 2026); initiate a ~100‑patient Phase 2a proof‑of‑concept (1H 2026) — randomized 1:1 BGE‑102 vs placebo for 12 weeks with primary endpoint percent change in hsCRP; Phase 2a data readout expected 2H 2026.

Why It Matters
These interim results highlight strong early biomarker effects (hsCRP, IL‑6, fibrinogen) in a population at elevated cardiovascular risk, which supports advancement into larger proof‑of‑concept testing. For investors, the items to watch are completion of the remaining Phase 1 cohorts, initiation and progress of the planned Phase 2a (~100 patients), upcoming data readouts (1H and 2H 2026), and how safety and clinical signals hold up in larger, placebo‑controlled studies. The issued patent may provide additional IP protection for the program.