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
Rhea-AI Summary
BioAge (Nasdaq: BIOA) reported interim Phase 1 MAD cohort results for BGE-102, an oral, brain-penetrant NLRP3 inhibitor for patients with obesity and elevated inflammation. In the 120 mg once-daily cohort (n=14), BGE-102 achieved a 86% median hsCRP reduction at Day 14 and 93% of participants reached hsCRP <2 mg/L; 71% reached ≤1 mg/L. BGE-102 also produced a 44% median IL-6 reduction, 30% fibrinogen reduction, and 93% IL-1β suppression in an ex vivo assay. Safety was favorable with no dose-limiting toxicities. Company plans full Phase 1 readout and Phase 2a initiation in 1H 2026.
Positive
- hsCRP median reduction of 86% at Day 14
- 93% of participants achieved hsCRP <2 mg/L
- 44% median reduction in serum IL-6 at Day 14
- 30% reduction in fibrinogen at Day 14
- 93% IL-1β suppression in ex vivo whole blood assay
Negative
- MAD cohort size was small (14 participants) for the 120 mg group
News Market Reaction
On the day this news was published, BIOA gained 27.23%, reflecting a significant positive market reaction. Argus tracked a peak move of +41.2% during that session. Our momentum scanner triggered 67 alerts that day, indicating high trading interest and price volatility. This price movement added approximately $162M to the company's valuation, bringing the market cap to $759M at that time. Trading volume was very high at 3.1x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Pre-news, BIOA was modestly higher while only one peer in the momentum set, SXTC, showed a move, down about 4.7% without news, suggesting stock-specific rather than sector-driven dynamics.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 08 | Reimbursement update | Positive | +1.9% | Leqembi added to China commercial innovative drug list for broader insurance access. |
| Dec 04 | Clinical data update | Positive | +14.0% | First interim Phase 1 BGE-102 data showed strong IL-1β suppression and brain penetration. |
| Dec 04 | Clinical data update | Positive | +14.0% | New Leqembi CTAD 2025 data suggested sizable delay in Alzheimer’s progression. |
| Nov 25 | Conference appearance | Neutral | +3.9% | Piper Sandler conference participation and investor meetings announcement. |
| Nov 18 | Upcoming data | Positive | -0.7% | Planned new Leqembi data presentations at CTAD conference in early December. |
News flow, especially positive clinical updates, has often aligned with favorable 24-hour price reactions, though there are occasional divergences on broader BioArctic-related headlines.
Over the last six months, BIOA has reported several notable milestones. Positive interim Phase 1 data for BGE-102 on Dec 4, 2025 coincided with a 13.99% gain, highlighting strong market sensitivity to clinical progress. Earlier, initiation of BGE-102 Phase 1 in Aug 2025 and obesity-focused preclinical data also saw positive reactions. Separate BioArctic/Leqembi Alzheimer’s updates and conference activities generally produced modest to strong gains, with only one small negative reaction, showing mostly constructive responses to scientific and commercial news.
Regulatory & Risk Context
An active Form S-3/A shelf filed on Nov 5, 2025 registers the resale of up to 2,227,124 common shares by an existing holder. The company is not selling shares and will not receive proceeds, and there has been no reported usage before this article.
Market Pulse Summary
The stock surged +27.2% in the session following this news. A strong positive reaction aligns with prior behavior, where December 2025 BGE-102 interim data coincided with a 13.99% move and clinical-trial headlines have averaged 3.72% swings. The robust hsCRP, IL-6, and fibrinogen reductions support the valuation focus on this asset. However, investors have an active S-3/A resale shelf for 2,227,124 shares to monitor, and any enthusiasm could fade if subsequent cohorts or the planned ~100-patient Phase 2a deliver less compelling biomarker effects.
Key Terms
nlrp3 inhibitor medical
il-6 medical
fibrinogen medical
cerebrospinal fluid medical
randomized, double-blind, placebo-controlled medical
AI-generated analysis. Not financial advice.
First BGE-102 MAD cohort completed in obese individuals with elevated hsCRP receiving 120 mg QD; demonstrated rapid and profound reduction in inflammatory markers
BGE-102 achieved
BGE-102 demonstrated significant reductions in IL-6, a key driver of systemic inflammation and cardiovascular risk, and fibrinogen, an independent predictor of cardiovascular events
BGE-102 was well tolerated with a favorable safety profile
Patent issued covering additional composition of matter and novel NLRP3 binding site
Full Phase 1 data, including additional MAD cohorts in obese participants with elevated hsCRP, anticipated 1H 2026; Phase 2a study on track to initiate in 1H 2026
EMERYVILLE, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ("BioAge"), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced additional positive interim data from the ongoing Phase 1 clinical trial evaluating BGE-102, a potent, structurally novel, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for the treatment of patients with cardiovascular risk factors.
In a multiple ascending dose (MAD) cohort of participants with obesity (BMI 32–42) and elevated baseline inflammation (hsCRP >3 mg/L), BGE-102 120 mg once daily achieved an
These findings build on positive interim data announced in December 2025 from SAD and initial MAD cohorts, which demonstrated that BGE-102 was well tolerated, achieved dose-proportional pharmacokinetics supporting once-daily dosing, and produced 90
“We are very encouraged by these results, which support the potential for BGE-102 to deliver injectable-like inflammation reduction in an oral therapy designed for primary care, the clinical setting where most cardiovascular risk is managed and where oral medicines are preferred by patients and physicians,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “Chronic inflammation is now recognized as a major driver of cardiovascular disease—on par with cholesterol—yet it remains far less commonly treated. An
Key findings from the MAD cohort in patients with obesity and elevated hsCRP
Rapid and profound hsCRP reduction
- BGE-102 achieved
83% median reduction in hsCRP (from a median baseline of 4.85 mg/L) at Day 7 and86% at Day 14 93% of participants (13/14) on BGE-102 achieved hsCRP <2 mg/L at Day 14;71% (10/14) reached ≤1 mg/L- Rapid onset of effect:
86% of BGE-102-dosed participants (12/14) achieved hsCRP levels <2 mg/L at Day 7;71% (10/14) reached ≤1 mg/L - hsCRP is the most widely used marker of inflammatory cardiovascular risk; levels below 2 mg/L are associated with reduced risk of cardiovascular events
Significant IL-6 reduction
- BGE-102 achieved a
44% median reduction in serum IL-6 at Day 14 - CSF IL-6 decreased in the two participants with elevated baseline levels, consistent with BGE-102's high brain penetration
- IL-6 is a key upstream driver of hsCRP production and a validated marker of cardiovascular risk
Significant fibrinogen reduction
- BGE-102 achieved a
30% reduction in fibrinogen at Day 14 - Elevated fibrinogen has been shown to be an independent predictor of cardiovascular events and thrombotic risk
Potent IL-1β suppression, consistent with strong target engagement
- In the ex vivo whole blood stimulation assay, BGE-102 achieved
93% suppression of IL-1β at trough (Day 14, pre-dose) - IL-1β is directly downstream of NLRP3 and drives production of IL-6 and CRP, key markers of cardiovascular risk
Safety and tolerability
- BGE-102 continued to be well tolerated
- Adverse events were infrequent, mild to moderate in severity, and self-limited, with no dose-dependent pattern observed
- No dose-limiting toxicities observed
Additional figures and data from the ongoing Phase 1 study are available in the Company's corporate presentation at https://ir.bioagelabs.com/.
"The substantial reductions in hsCRP, IL-6, and fibrinogen we observed in participants with obesity and elevated inflammation demonstrate that BGE-102 potently suppresses the NLRP3-driven inflammatory cascade in a clinically relevant population," said Paul Rubin, MD, Chief Medical Officer of BioAge. "These data provide strong rationale for advancing into our planned Phase 2a study, where we will evaluate BGE-102's effects on a range of key inflammatory biomarkers over a longer duration in patients with elevated cardiovascular risk."
Phase 1 study design
The ongoing Phase 1 study is a randomized, double-blind, placebo-controlled trial in healthy volunteers and participants with obesity. Part 1 evaluated single ascending doses at four dose levels (10, 30, 60, and 120 mg); Part 2 to date has evaluated multiple ascending doses administered once daily for 14 days in healthy volunteers (60 and 120 mg) and in participants with obesity and elevated hsCRP (120 mg QD cohort complete; two lower-dose QD cohorts ongoing). Pharmacodynamic effects were evaluated by assessment of serum biomarkers including hsCRP, IL-6, and fibrinogen, as well as an ex vivo whole blood stimulation assay measuring IL-1β suppression.
Anticipated milestones for BGE-102 in cardiovascular disease
- 1H 2026: Completion of Phase 1 trial with full data readout, including two additional MAD cohorts in obese participants with elevated hsCRP
- 1H 2026: Initiation of Phase 2a proof-of-concept study in patients with obesity and cardiovascular risk factors. The trial is planned to enroll approximately 100 patients randomized 1:1 to BGE-102 monotherapy or placebo for 12 weeks. The anticipated primary endpoint is percent change in hsCRP. The trial will also assess inflammatory and metabolic biomarkers, and will include liver MRI.
- 2H 2026: Phase 2a data readout
Background on BGE-102 and NLRP3
BGE-102 is a potent, orally available, brain-penetrant small molecule NLRP3 inhibitor being developed for diseases of inflammation including elevated cardiovascular risk. BGE-102 represents a structurally novel class of NLRP3 inhibitors developed by BioAge with a unique mechanism and binding site. NLRP3 is a key driver of age-related inflammation that has been implicated in a broad range of diseases, including cardiovascular disease, neurodegeneration, and metabolic disorders.
About BioAge Labs, Inc.
BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company's lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk factors. A Phase 1 SAD/MAD trial of BGE-102 is underway, with topline data including additional MAD cohorts anticipated in 1H26. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Forward-looking statements
This press release contains "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our plans to develop and commercialize our product candidates, including BGE-102 and our APJ program, the potential for BGE-102 as a treatment for cardiovascular risk and the expected timeline for future data readouts from our ongoing Phase 1 clinical trial, the timing and results of our clinical trials, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of and our ability to obtain and maintain regulatory approvals and the clinical utility of our product candidates. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive interim results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading "Risk Factors" included in BioAge's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 6, 2025, and BioAge's other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Contacts
PR: Chris Patil, media@bioagelabs.com
IR: Dov Goldstein, ir@bioagelabs.com
Partnering: Peng Leong, partnering@bioagelabs.com
Web: https://bioagelabs.com
FAQ
What did BioAge (BIOA) report for BGE-102 in the 120 mg MAD cohort on January 12, 2026?
How did BGE-102 affect IL-6 and fibrinogen in the Phase 1 MAD cohort for BIOA?
What safety findings did BioAge report for BGE-102 in the Phase 1 study (BIOA)?
When does BioAge expect the full Phase 1 readout and Phase 2a start for BGE-102 (BIOA)?
Does BGE-102 show brain penetration in BioAge's Phase 1 data (BIOA)?
