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BioAge Announces Additional Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor, Demonstrating Potential for Best-in-Class hsCRP Reduction in Participants with Elevated Cardiovascular Risk

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First BGE-102 MAD cohort completed in obese individuals with elevated hsCRP receiving 120 mg QD; dem...

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AI Summary

BGE-102 showed 86% reduction in hsCRP in obese participants. 93% of participants achieved hsCRP levels below 2 mg/L, reducing cardiovascular risk. BGE-102 displayed significant reductions in IL-6 and fibrinogen biomarkers. Positive interim results support advancement to Phase 2a study in H1 2026. Patent issued for BGE-102 enhances its intellectual property protection.

Sentiment Rationale

The significant efficacy of BGE-102 in reducing inflammation may boost investor confidence. Historical examples show that successful clinical trial results often lead to stock price increases in biotech firms.

Trading Thesis

As BGE-102 progresses through clinical trials, its potential as a treatment could significantly increase BIOA's value over time. Previous successful products in similar stages have led to sustained upward trends in stock prices.

Market-Moving

  • BGE-102 showed 86% reduction in hsCRP in obese participants.
  • 93% of participants achieved hsCRP levels below 2 mg/L, reducing cardiovascular risk.
  • BGE-102 displayed significant reductions in IL-6 and fibrinogen biomarkers.

Key Facts

  • BGE-102 showed 86% reduction in hsCRP in obese participants.
  • 93% of participants achieved hsCRP levels below 2 mg/L, reducing cardiovascular risk.
  • BGE-102 displayed significant reductions in IL-6 and fibrinogen biomarkers.
  • Positive interim results support advancement to Phase 2a study in H1 2026.
  • Patent issued for BGE-102 enhances its intellectual property protection.

Companies Mentioned

  • BMY (BMY)
  • PFE (PFE)
  • JNJ (JNJ)

Research Analysis

The article presents compelling clinical trial results, crucial for investors in BioAge, especially with the upcoming Phase 2a study.

BioAge Reports Promising Interim Phase 1 Results for BGE-102, a Leading NLRP3 Inhibitor

On January 12, 2026, BioAge Labs, Inc. (Nasdaq: BIOA) announced exciting interim findings from its ongoing Phase 1 clinical trial for BGE-102, a novel orally-administered NLRP3 inhibitor targeting inflammation linked to cardiovascular risk. This data showcases a significant reduction in inflammatory markers, suggesting BGE-102 could emerge as a best-in-class therapy for cardiovascular patients.

Key Findings from the Phase 1 Trial

The completed multiple ascending dose (MAD) cohort involved participants with obesity (BMI 32–42) and elevated high-sensitivity C-reactive protein (hsCRP) levels. The results revealed:

  • 86% Reduction in hsCRP: Participants receiving 120 mg of BGE-102 once daily showed an 86% median reduction in hsCRP levels at Day 14, with 93% achieving levels below 2 mg/L, the threshold indicating reduced cardiovascular risk.
  • Significant IL-6 and Fibrinogen Reductions: BGE-102 demonstrated a 44% reduction in IL-6, a well-recognized marker of systemic inflammation, and a 30% decrease in fibrinogen, independently linked to cardiovascular events.
  • Strong Safety Profile: BGE-102 was well tolerated, with few mild adverse events reported, and no dose-dependent toxicity observed.

Implications of BGE-102’s Results

Dr. Kristen Fortney, CEO and co-founder of BioAge, expressed optimism about the findings, emphasizing the need for effective oral therapies in primary care settings. The data supports the potential of BGE-102 to provide rapid and substantial inflammation reduction comparable to injectable therapies.

“Chronic inflammation is a primary contributor to cardiovascular disease, but remains under-treated,” commented Dr. Fortney. “An 86% reduction in hsCRP, with the majority of participants reaching safe levels, could position BGE-102 as a groundbreaking treatment option.”

Phase 2a Study and Future Prospects

Looking ahead, BioAge plans to initiate a Phase 2a proof-of-concept study in the first half of 2026. This study will involve approximately 100 patients with obesity and cardiovascular risk factors, assessing the effects of BGE-102 on hsCRP and other biomarkers over a 12-week period.

Key milestones for the development of BGE-102 include:

  • Completion of the Phase 1 trial and full data readout in 1H 2026.
  • Initiation of the Phase 2a study also in 1H 2026.
  • Expected data readout for Phase 2a in 2H 2026.

Understanding BGE-102 and NLRP3

BGE-102 is a pioneering small molecule NLRP3 inhibitor designed to combat inflammation linked to various diseases, including cardiovascular issues. By targeting the NLRP3 pathway, which is a significant player in age-related inflammation, BGE-102 offers the potential to address critical health concerns.

About BioAge Labs, Inc.

BioAge Labs, Inc. is a clinical-stage biopharmaceutical company devoted to developing therapies for metabolic diseases by addressing the biological aspects of human aging. The advancement of BGE-102 highlights the company's commitment to innovative cardiovascular therapies.

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