BGE-102 / BioAge Labs - LARVOL DELTA

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

BioAge Labs Reports Full Year 2024 Financial Results and Provides Business Updates from the Fourth Quarter of 2024 (GlobeNewswire) - "NLRP3 inhibitors: progression of BGE-102: Potential for use in an oral combination for obesity: in preclinical models, NLRP3 inhibition has demonstrated weight loss both as a monotherapy and in combination with a GLP-1 receptor agonist....IND-enabling experiments for BGE-102 are currently underway, with Phase 1 single ascending dose (SAD) data anticipated in 2H25 and multiple ascending dose (MAD) data anticipated in 1H26."

P1 data • Preclinical • Obesity

Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025 (GlobeNewswire) - "BioAge is developing its novel, proprietary class of NLRP3 inhibitors, which have distinctive structural and biological properties and include molecules that penetrate the blood–brain barrier, for diseases associated with neuroinflammation. The Company has nominated a member of this class, the orally available, small-molecule brain-penetrant NLRP3 inhibitor BGE-102, as a development candidate. The structurally novel drug has potential best-in-class features, including high potency and high brain penetration, an important attribute for a compound that could be used for treatment of neuroinflammation linked to conditions such as obesity. IND-enabling experiments for BGE-102 are currently underway, and Phase 1 SAD data are anticipated by the end of 2025."

New molecule • P1 data • Inflammation • Obesity