BGE-102 / BioAge Labs - LARVOL DELTA

BioAge Labs Announces First Participant Dosed in QUELL-DME, a Phase 2 Trial of BGE-102, a Novel Oral NLRP3 Inhibitor, in Diabetic Macular Edema (GlobeNewswire) - "The approximately 180-participant study will evaluate BGE-102 both as monotherapy and in combination with standard-of-care anti-VEGF therapy, with change in best-corrected visual acuity at week 12 as the primary endpoint....Topline results are anticipated in the second half of 2027."

P2 data • Trial status • Diabetic Macular Edema

BioAge is also conducting QUELL-CV, a Phase 2 dose-ranging trial evaluating BGE-102 in patients with obesity and elevated baseline inflammation (GlobeNewswire) - "QUELL-CV has completed enrollment, and topline data are anticipated in the second half of 2026."

Enrollment closed • P2 data • Cardiovascular • Obesity

A Phase 1 Study of BGE-102, a Novel Oral NLRP3 Inhibitor, in Healthy Volunteers and Participants with Obesity and Elevated High-Sensitivity C-Reactive Protein (AHA 2026) - "Abstract is embargoed at this time."

Clinical • P1 data • Genetic Disorders • Obesity • CRP • NLRP3

QUELL-DME: A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: BioAge Labs, Inc.

New P2 trial • Diabetic Macular Edema • Ophthalmology

A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: BioAge Labs, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Genetic Disorders • Obesity

BGE-102 clinical development: QUELL-DME Phase 1b/2a trial (GlobeNewswire) - "Following an indication expansion into ocular diseases, the Company plans to initiate QUELL-DME, a Phase 1b/2a proof-of-concept trial of BGE-102 in patients with diabetic macular edema, in mid-2026; results are anticipated in mid-2027."

New P1/2 trial • P1/2 data • Diabetic Macular Edema

BGE-102 clinical development: QUELL-CV Phase 2 trial (GlobeNewswire) - "In June 2026, BioAge announced that the first participant was dosed in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of BGE-102, its oral, brain-penetrant NLRP3 inhibitor, measuring inflammatory and cardiometabolic biomarkers...The trial is designed to characterize the dose-response relationship for BGE-102 and to support dose selection for further development, with topline data anticipated in the second half of 2026."

P2 data • Trial status • Cardiovascular • Obesity

A Phase 2 Study to Evaluate the Pharmacodynamics, Safety and Tolerability of BGE-102 in Participants With Obesity and Cardiovascular Risk Factors (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: BioAge Labs, Inc.

New P2 trial • Cardiovascular • Genetic Disorders • Obesity • CRP

Oral NLRP3 Inhibitor BGE-102 Preserves Retinal Vascular Integrity in a Preclinical Model of Diabetic Retinopathy (ADA 2026) - "Oral BGE-102 preserved retinal vascular integrity and restored endothelial tight junctions in a DR model, with efficacy independent of glycemic control. These findings support NLRP3 inhibition as a novel approach to DR and the planned Phase 1b/2a trial in diabetic macular edema."

Late-breaking abstract • Preclinical • Diabetes • Metabolic Disorders • CLDN5 • NLRP3

BGE-102, a Novel NLRP3 Inhibitor, Demonstrated Robust Anti-Inflammatory Activity in an Ongoing Phase 1 Study in Healthy Volunteers and Participants with Obesity (ADA 2026) - "BGE-102 was well tolerated and showed sustained IL-1β suppression in treated participants and significant hsCRP reduction in participants with obesity. These results support advancing BGE-102 into proof-of-concept studies for metabolic and inflammatory conditions."

Clinical • P1 data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus • CRP • IL1B • NLRP3

First Quarter 2026 Business Highlights (GlobeNewswire) - "The Company plans to initiate a Phase 1b/2a proof-of-concept trial in mid-2026, with results anticipated in mid-2027...APJ agonist program advancement...The Company intends to file its first IND for an APJ program by year-end 2026."

IND • New P1/2 trial • P1/2 data • Diabetic Macular Edema • Obesity

Proof-of-concept trial in diabetic macular edema (DME) (GlobeNewswire) - "BioAge also plans to initiate a Phase 1b/2a proof-of-concept study evaluating BGE-102 in patients with DME in mid-2026, with results anticipated in mid-2027. The trial is designed to demonstrate pharmacodynamic target engagement for BGE-102 in the eye, supporting future development in inflammation-driven retinal diseases. Additional details on the ophthalmology program can be found in the corporate presentation."

New P1/2 trial • P1/2 data • Diabetic Macular Edema

BioAge Reports Positive Phase 1 Data for BGE-102, a Novel Oral NLRP3 Inhibitor, Demonstrating Potential Best-in-Class Reductions in hsCRP (GlobeNewswire) - "60 mg QD (21-day dosing): 85% reduction at Day 7, 80% at Day 14, 86% at Day 21; 87% of participants on active treatment (13/15) achieved normalized hsCRP (<2 mg/L) at Day 21, with 60% (9/15) reaching ≤1 mg/L...120 mg QD (14-day dosing): 83% reduction at Day 7, 86% at Day 14; 93% of participants on active treatment (13/14) achieved normalized hsCRP (<2 mg/L) at Day 14, with 71% (10/14) reaching ≤1 mg/L...60 mg QD: 78% reduction at Day 7, 70% at Day 14, 55% at Day 21; 120 mg QD: 69% reduction at Day 7, 58% at Day 14...BGE-102 was well tolerated across all dose levels evaluated in the Phase 1 study."

P1 data • Obesity

BGE-102 indication expansion into ophthalmology (The Manila Times) - "The Company plans to initiate a Phase 1b/2a proof-of-concept trial in patients with DME in mid-2026, with results anticipated in mid-2027."

New P1/2 trial • P1/2 data • Diabetic Macular Edema

NLRP3 inhibitor clinical development (The Manila Times) - "Full Phase 1 data are anticipated in the first half of 2026; The Company plans to initiate a Phase 2a proof-of-concept trial in cardiovascular risk in the first half of 2026. The trial has been expanded to incorporate dose-ranging, with the goal of potentially enabling initiation of a Phase 3 registration study by the end of 2027. Phase 2a data are expected in the second half of 2026."

New P2a trial • P1 data • P2a data • Cardiovascular • Obesity

Anticipated milestones for BGE-102 in cardiovascular disease (GlobeNewswire) - "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."

New P2a trial • P1 data • P2a data • Cardiovascular • Inflammation • Obesity

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 (GlobeNewswire) - "BGE-102 achieved 83% median reduction in hsCRP (from a median baseline of 4.85 mg/L) at Day 7 and 86% 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...BGE-102 achieved a 44% median reduction in serum IL-6 at Day 14...BGE-102 achieved a 30% reduction in fibrinogen at Day 14."

P1 data • Cardiovascular • Obesity

BioAge Announces Indication Expansion for Oral NLRP3 Inhibitor BGE-102, with Plans to Initiate Phase 1b/2a Proof-of-Concept Clinical Trial in Patients with Diabetic Macular Edema in Mid-2026 (GlobeNewswire) - "In a preclinical model of DME, oral BGE-102 demonstrated dose-dependent preservation of retinal vascular integrity, achieving near-complete protection from vascular leakage and up to 90% preservation of microvascular integrity...BioAge plans to initiate a Phase 1b/2a POC trial in patients with DME in mid-2026...The goal of the POC trial will be to demonstrate target engagement and pharmacodynamics (PD) for BGE-102 in the eye to motivate future clinical development in retinal diseases driven by inflammation....Results are anticipated in mid-2027."

New P1/2 trial • P1/2 data • Preclinical • Diabetic Macular Edema

BioAge Announces Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor (GlobeNewswire) - "Adverse events were infrequent and mild to moderate in severity, and all resolved without intervention; full analysis to follow after database lock and unblinding in the first half of 2026...Dose proportionality observed across doses tested; BGE-102 treatment achieved 90% (60 mg dose) to 98% (120 mg dose) suppression of IL-1β production in an ex vivo whole blood stimulation assay prior to dosing on Day 14...In MAD cohorts, BGE-102 doses of 60 mg and higher resulted in CSF concentrations exceeding the IC90 after 14 days; High brain penetration is a key differentiator from other NLRP3 inhibitors in development, enabling the targeting of both peripheral and central inflammation."

P1 data • Cardiovascular • Obesity

Anticipated Milestones (GlobeNewswire) - "1H26: Completion of Phase 1 MAD cohorts in obese participants with elevated hsCRP, evaluating changes in key inflammatory biomarkers including hsCRP and IL-1β; 1H26: 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 placebo or BGE-102 monotherapy for 12 weeks. The anticipated primary endpoint of the trial is percent change in hsCRP. Additionally, the trial will assess a range of inflammatory and metabolic biomarkers, and will include MRI imaging; 2H26: Phase 2a data readout."

New P2a trial • Trial status • Obesity

An Oral Brain-Penetrant NLRP3 Inhibitor Improves Weight Loss and Glycemic Control in Obese Mice (OBESITY WEEK 2025) - "BGE-102 demonstrated robust dose-dependent weight loss as monotherapy, with high-dose treatment exceeding weight loss achieved with semaglutide. Combination therapy with semaglutide produced additional weight loss, achieving nearly 25% weight reduction while preserving lean mass to body weight percentage, addressing a critical limitation of current obesity treatments. Strong brain penetration and the correlation between CSF exposure and response support a neuroinflammation-targeting mechanism."

Preclinical • Genetic Disorders • Inflammation • Obesity • NLRP3

NLRP3 inhibitor program clinical development (The Manila Times) - "The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. Initial single ascending dose (SAD) data are anticipated by the end of 2025. Following successful completion of the Phase 1 SAD/MAD, the Company plans to initiate a proof-of-concept clinical trial for BGE-102, with top-line data for this study anticipated in the second half of 2026."

Clinical data • New trial • Obesity

BioAge Labs Announces First Participant Dosed in Phase 1 Clinical Trial of BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor (GlobeNewswire) - "The Phase 1 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants....Following successful completion of the Phase 1 study, with initial SAD data expected by year-end 2025, BioAge plans to advance BGE-102 into a proof-of-concept study in obesity in 2026, with top-line data anticipated by end of year."

New trial • P1 data • Trial status • Obesity

BioAge Labs completes IND-enabling studies for BGE-102, a potent, orally available, brain-penetrant NLRP3 inhibitor, and advances candidate toward the clinic (GlobeNewswire) - "In preclinical models of obesity, BGE-102 monotherapy produced dose-dependent weight loss similar in magnitude to semaglutide, with optimal doses achieving approximately 15% weight reduction. The weight loss, driven by reduced food intake, was sustained over 28 days of treatment. BGE-102 treatments also yielded improvements in insulin sensitivity, similar in magnitude to those seen with semaglutide....BioAge plans to submit an Investigational New Drug (IND) application for BGE-102 in mid-2025. Following IND clearance, the Company expects to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial, with initial SAD data anticipated by the end of 2025. Following successful Phase 1 results, BioAge plans to initiate a Phase 1b proof-of-concept study in obesity in the second half of 2026."

IND • New P1 trial • Preclinical • Obesity

NLRP3 program development (GlobeNewswire) - "In preclinical studies, NLRP3 inhibition has demonstrated significant weight loss potential. IND-enabling studies are currently underway, with initial Phase 1 data anticipated in the second half of 2025...Research and development expenses were $11.1 million for the quarter ended March 31, 2025, compared to $9.3 million for the same period in 2024. The $1.8 million increase in research and development expenses was primarily attributable to a $2.7 million increase in direct costs related to other programs as BioAge focused its research and development activities on IND-enabling activities for BGE-102."

Commercial • P1 data • Obesity