BioAge Labs Announces First Participant Dosed in Phase 1 Clinical Trial of BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor
BioAge Labs (NASDAQ:BIOA) has initiated Phase 1 clinical trials for BGE-102, a novel brain-penetrant NLRP3 inhibitor targeting obesity. The compound represents a new class of NLRP3 inhibitors with high potency and once-daily oral dosing potential.
In preclinical studies, BGE-102 demonstrated impressive results, achieving up to 15% weight loss as monotherapy and 25% weight reduction when combined with semaglutide. The Phase 1 trial will evaluate safety, tolerability, and pharmacological properties in healthy participants through a randomized, double-blind, placebo-controlled study.
BioAge expects initial SAD data by end of 2025 and plans to advance to a proof-of-concept obesity study in 2026, with top-line data expected by end of 2026.
BioAge Labs (NASDAQ:BIOA) ha avviato le sperimentazioni cliniche di Fase 1 per BGE-102, un nuovo inibitore dell'NLRP3 in grado di attraversare la barriera emato-encefalica e sviluppato per il trattamento dell'obesit脿. Il composto appartiene a una nuova classe di inibitori NLRP3 caratterizzati da elevata potenza e potenziale somministrazione orale una volta al giorno.
Negli studi preclinici, BGE-102 ha mostrato risultati notevoli, con perdite di peso fino al 15% quando somministrato come monoterapia e fino al 25% se combinato con semaglutide. Lo studio di Fase 1 valuter脿 sicurezza, tolerabilit脿 e parametri farmacologici in soggetti sani mediante uno studio randomizzato, in doppio cieco e controllato con placebo.
BioAge prevede di ottenere i primi dati SAD entro la fine del 2025 e intende proseguire con uno studio proof-of-concept sull'obesit脿 nel 2026, con dati top-line previsti entro la fine del 2026.
BioAge Labs (NASDAQ:BIOA) ha iniciado los ensayos cl铆nicos de Fase 1 de BGE-102, un nuevo inhibidor de NLRP3 capaz de penetrar el cerebro y dirigido a la obesidad. El compuesto representa una nueva clase de inhibidores de NLRP3 con alta potencia y potencial para dosis orales una vez al d铆a.
En estudios precl铆nicos, BGE-102 mostr贸 resultados impresionantes, logrando hasta un 15% de p茅rdida de peso como monoterapia y hasta un 25% de reducci贸n cuando se combin贸 con semaglutida. El ensayo de Fase 1 evaluar谩 la seguridad, la tolerabilidad y las propiedades farmacol贸gicas en participantes sanos mediante un estudio aleatorizado, doble ciego y controlado con placebo.
BioAge espera contar con los datos iniciales SAD a finales de 2025 y planea avanzar a un estudio de prueba de concepto en obesidad en 2026, con datos principales esperados a finales de 2026.
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BioAge Labs (NASDAQ:BIOA) a lanc茅 des essais cliniques de phase 1 pour BGE-102, un nouvel inhibiteur de NLRP3 p茅n茅trant le cerveau et ciblant l'ob茅sit茅. Le compos茅 repr茅sente une nouvelle classe d'inhibiteurs de NLRP3 avec une forte puissance et un potentiel d'administration orale une fois par jour.
Dans les 茅tudes pr茅cliniques, BGE-102 a montr茅 des r茅sultats impressionnants, entra卯nant jusqu'脿 15% de perte de poids en monoth茅rapie et 25% de r茅duction lorsqu'il 茅tait combin茅 脿 la s茅maglutide. L'essai de phase 1 茅valuera la s茅curit茅, la tol茅rabilit茅 et les propri茅t茅s pharmacologiques chez des volontaires sains dans le cadre d'une 茅tude randomis茅e, en double aveugle et contr么l茅e par placebo.
BioAge pr茅voit d'obtenir les premi猫res donn茅es SAD d'ici la fin 2025 et compte passer 脿 une 茅tude de preuve de concept sur l'ob茅sit茅 en 2026, avec des donn茅es principales attendues d'ici la fin 2026.
BioAge Labs (NASDAQ:BIOA) hat mit Phase鈥�1鈥慘linikstudien f眉r BGE-102 begonnen, einen neuartigen, gehirndurchdringenden NLRP3鈥慖nhibitor gegen Adipositas. Der Wirkstoff repr盲sentiert eine neue Klasse von NLRP3鈥慖nhibitoren mit hoher Potenz und Potenzial f眉r einmal t盲gliche orale Gabe.
In pr盲klinischen Studien erzielte BGE-102 beeindruckende Ergebnisse und f眉hrte als Monotherapie zu Gewichtsverlusten von bis zu 15% bzw. zu 25% Gewichtsreduktion, wenn es mit Semaglutid kombiniert wurde. Die Phase鈥�1鈥慡tudie wird Sicherheit, Vertr盲glichkeit und pharmakologische Eigenschaften bei gesunden Probanden in einer randomisierten, doppelblinden, placebokontrollierten Studie untersuchen.
BioAge rechnet mit ersten SAD鈥慏aten bis Ende 2025 und plant, 2026 in eine Proof鈥憃f鈥慍oncept鈥慡tudie zur Adipositas vorzur眉cken, mit Topline鈥慏aten, die bis Ende 2026 erwartet werden.
- Preclinical studies showed 15% weight loss with BGE-102 monotherapy, comparable to semaglutide
- Combination with semaglutide achieved 25% weight reduction in preclinical models
- Strong safety profile demonstrated in GLP toxicology studies with no adverse findings
- High brain penetration and once-daily oral dosing potential offers competitive advantage
- Early-stage development with no human efficacy data yet available
- Significant timeline to market with Phase 1 data not expected until end of 2025
Insights
BioAge begins Phase 1 trial of promising NLRP3 inhibitor BGE-102 for obesity with strong preclinical data showing potential combination value with GLP-1s.
BioAge's Phase 1 dosing of BGE-102 represents a significant milestone in the development of a potentially differentiated obesity treatment. This orally available NLRP3 inhibitor targets a mechanism distinct from current therapies by addressing inflammation's role in metabolic dysfunction. The preclinical data is particularly noteworthy, demonstrating
The drug's high brain penetration is scientifically significant as it enables targeting of neuroinflammation that disrupts appetite regulation. This dual-action approach鈥攁ddressing both central and peripheral inflammation鈥攃ould offer advantages over existing treatments. The compound's once-daily oral dosing profile would be substantially more convenient than injectable GLP-1s, potentially improving treatment adherence.
What's scientifically compelling is how BioAge identified NLRP3 as a target through human aging cohort analysis, showing reduced NLRP3 activity correlates with longevity. The clean safety profile in GLP toxicology studies further strengthens the candidate's potential. The comprehensive Phase 1 design, which includes pharmacodynamic assessment through inflammatory biomarkers and cerebrospinal fluid sampling to confirm CNS penetration, should provide robust early human data by year-end 2025, with obesity efficacy results expected by late 2026.
BioAge's advancement of BGE-102 into clinical testing positions the company within a highly competitive landscape for next-generation obesity treatments. The market is actively seeking oral alternatives and complementary agents to GLP-1 receptor agonists, which have established a high efficacy bar but face challenges with injectable administration and side effects.
The preclinical profile shows strategic positioning in two potentially lucrative market segments: as monotherapy for patients seeking oral options, and as a combination therapy that could enhance GLP-1 efficacy. The additive effect with semaglutide is particularly significant as it suggests BGE-102 could become part of combination regimens that might achieve greater weight loss than current standards of care.
The NLRP3 inflammasome target represents a novel mechanism in obesity treatment that addresses underlying inflammatory pathways rather than solely focusing on appetite or energy expenditure. This mechanistic differentiation is crucial in a crowded obesity pipeline. The brain penetration feature further distinguishes BGE-102 from other NLRP3 inhibitors in development, potentially expanding its applications to conditions with neuroinflammatory components.
While promising, investors should note the early stage鈥攆irst-in-human testing with efficacy data not expected until end of 2026. The timeline suggests market entry wouldn't occur before 2028-2029, during which time the competitive landscape will continue evolving. Nevertheless, this milestone establishes BioAge as a clinical-stage player in the rapidly expanding obesity treatment market, currently dominated by major pharmaceutical companies with established commercial infrastructure.
First-in-human study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102, an orally available small molecule with potential best-in-class profile
Initial development planned in obesity; BGE-102 demonstrated robust weight loss in preclinical models, both as monotherapy and in combination with GLP-1 receptor agonists
Initial Phase 1 SAD data anticipated by end of 2025, with top-line readout of obesity study by end of 2026
EMERYVILLE, Calif., Aug. 15, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. (Nasdaq: BIOA) ("BioAge", "the Company"), a clinical-stage biotechnology company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced that the first participant has been dosed in a Phase 1 clinical trial evaluating BGE-102, a structurally novel, orally available small molecule NLRP3 inhibitor with high potency and brain penetration being developed initially for the treatment of obesity.
BGE-102 represents a structurally novel class of NLRP3 inhibitors developed by BioAge. NLRP3 is a key driver of age-related inflammation that has been implicated in a broad range of diseases, including neurodegenerative conditions and cardiovascular disease as well as metabolic disorders such as obesity. BioAge鈥檚 discovery platform identified NLRP3 as a therapeutic target based on analysis of human aging cohorts, which revealed that reduced NLRP3 activity is associated with greater longevity.
The Company鈥檚 research has shown that the new molecules inhibit the NLRP3 inflammasome through a unique binding site and mechanism distinct from other NLRP3 inhibitors in development [, ]. The compound has demonstrated high potency consistent with once-daily oral human dosing along with high brain penetration, supporting its potential to address both neuroinflammation鈥攚hich disrupts appetite regulation in the brain鈥攁nd systemic inflammation associated with obesity and cardiovascular risk. BGE-102 has shown a strong safety profile in GLP toxicology studies that revealed no adverse findings [].
In preclinical obesity models, BGE-102 monotherapy achieved dose-dependent weight loss of up to
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. Part 1 will assess single ascending doses; Part 2 will evaluate multiple ascending doses administered once daily for 14 days. The study is designed to characterize BGE-102's pharmacokinetic profile through blood sampling, assess CNS penetration through cerebrospinal fluid sampling, and evaluate pharmacodynamic effects using an ex vivo whole blood stimulation assay that measures BGE-102's ability to inhibit the production of key inflammatory signals such as IL-1尾.
"We're excited to announce the dosing of our first participant in the Phase 1 trial for BGE-102 - a significant milestone in our mission to target the biology of aging and transform obesity treatment," said Kristen Fortney, PhD, CEO and co-founder of BioAge. "This study was designed to deliver key data on safety, dosing, and activity. By inhibiting NLRP3-driven inflammation, a core driver of metabolic dysfunction, BGE-102 has the potential to complement existing therapies like GLP-1 agonists to enhance weight loss and curb excess inflammation. We believe that with convenient once-daily oral dosing and exceptional brain penetration, BGE-102 is positioned to tackle neuroinflammation in obesity and related conditions, offering versatility as a standalone or combination option."
Following successful completion of the Phase 1 study, with initial聽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.
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 obesity. BGE-102 has demonstrated significant weight loss in preclinical models both as monotherapy and in combination with GLP-1 receptor agonists. A Phase 1 SAD/MAD trial of BGE-102 is underway, with initial SAD data anticipated by end of year. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge鈥檚 additional preclinical programs, which leverage insights from the Company鈥檚 proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging.
Forward-looking statements
This press release contains 鈥渇orward-looking statements鈥� 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 obesity and the expected timeline for data readout from our ongoing Phase 1 clinical trial, the timing and results of our clinical activities, risks associated with clinical trials, including our ability to adequately manage clinical activities, the timing of our IND filing for our APJ program, our ability to obtain and maintain regulatory approvals, the clinical utility of our product candidates or their ultimate ability to treat human disease, the expected timeline for completing proteomic analysis, anticipated analytical results and the potential for identifying novel therapeutic targets, and general economic, industry and market conditions. These forward-looking statements may be accompanied by such words as 鈥渁im,鈥� 鈥渁nticipate,鈥� 鈥渂elieve,鈥� 鈥渃ould,鈥� 鈥渆stimate,鈥� 鈥渆xpect,鈥� 鈥渇orecast,鈥� 鈥済oal,鈥� 鈥渋ntend,鈥� 鈥渕ay,鈥� 鈥渕ight,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥減ossible,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 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 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 鈥淩isk Factors鈥� included in BioAge鈥檚 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on August 6, 2025, and BioAge鈥檚 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, [email protected]
IR: Dov Goldstein, [email protected]
Partnering: [email protected]
Web: https://bioagelabs.com
FAQ
What is BGE-102 and how does it work for obesity treatment?
What were the weight loss results for BGE-102 in preclinical studies?
When will BioAge (BIOA) release the first clinical trial results for BGE-102?
What makes BGE-102 different from other obesity treatments?
How is BioAge's Phase 1 trial for BGE-102 structured?
