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MBX Biosciences to Present at the American Diabetes Association 85th Scientific Sessions

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MBX Biosciences announced two presentations at the American Diabetes Association's 85th Scientific Sessions in Chicago from June 20-23, 2025. The presentations focus on MBX 1416, a Glucagon-Like Peptide-1 Receptor Antagonist, showcasing its safety, pharmacokinetics, and pharmacodynamics in healthy volunteers from a Phase 1 trial, as well as its effects on blood glucose in rats. The findings demonstrate MBX 1416's potential as a once-weekly treatment for post-bariatric hypoglycemia (PBH). The company previously reported positive topline results from a Phase 1 SAD/MAD trial and plans to initiate a Phase 2 trial in the second half of 2025.
MBX Biosciences ha annunciato due presentazioni alle 85ª Sessioni Scientifiche dell'American Diabetes Association che si terranno a Chicago dal 20 al 23 giugno 2025. Le presentazioni riguardano MBX 1416, un antagonista del recettore del Glucagone-Like Peptide-1, evidenziandone la sicurezza, la farmacocinetica e la farmacodinamica in volontari sani durante uno studio di Fase 1, oltre ai suoi effetti sulla glicemia nei ratti. I risultati dimostrano il potenziale di MBX 1416 come trattamento settimanale per l'ipoglicemia post-bariatrica (PBH). L'azienda aveva già riportato risultati positivi preliminari da uno studio di Fase 1 SAD/MAD e prevede di avviare uno studio di Fase 2 nella seconda metà del 2025.
MBX Biosciences anunció dos presentaciones en las 85ª Sesiones Científicas de la Asociación Americana de Diabetes, que se llevarán a cabo en Chicago del 20 al 23 de junio de 2025. Las presentaciones se centran en MBX 1416, un antagonista del receptor del péptido similar al glucagón-1, mostrando su seguridad, farmacocinética y farmacodinámica en voluntarios sanos en un ensayo de Fase 1, así como sus efectos sobre la glucosa en sangre en ratas. Los hallazgos demuestran el potencial de MBX 1416 como tratamiento semanal para la hipoglucemia postbariátrica (PBH). La compañía había informado previamente resultados positivos preliminares de un ensayo SAD/MAD de Fase 1 y planea iniciar un ensayo de Fase 2 en la segunda mitad de 2025.
MBX 바이오사이언스는 2025년 6월 20일부터 23일까지 시카고에서 열리는 미국 당뇨병학회(ADA) 제85차 학술회의에서 두 건의 발표를 진행할 예정입니다. 발표 내용은 GLP-1 수용체 길항제인 MBX 1416의 안전성, 약동학 및 약력학을 건강한 지원자를 대상으로 한 1상 임상시험 결과와 쥐에서의 혈당 조절 효과에 관한 것입니다. 연구 결과는 MBX 1416이 비만 수술 후 저혈당증(PBH)에 대해 주 1회 투여 가능한 치료제로서의 가능성을 보여줍니다. 회사는 이전에 1상 SAD/MAD 임상시험에서 긍정적인 초기 결과를 보고했으며, 2025년 하반기에 2상 임상을 시작할 계획입니다.
MBX Biosciences a annoncé deux présentations lors des 85èmes Sessions Scientifiques de l'American Diabetes Association, qui se tiendront à Chicago du 20 au 23 juin 2025. Ces présentations portent sur le MBX 1416, un antagoniste du récepteur du peptide-1 de type glucagon, mettant en avant sa sécurité, sa pharmacocinétique et sa pharmacodynamie chez des volontaires sains lors d'un essai de phase 1, ainsi que ses effets sur la glycémie chez les rats. Les résultats démontrent le potentiel du MBX 1416 en tant que traitement hebdomadaire pour l'hypoglycémie post-bariatrique (PBH). La société avait précédemment rapporté des résultats positifs préliminaires issus d'un essai SAD/MAD de phase 1 et prévoit de lancer un essai de phase 2 dans la seconde moitié de 2025.
MBX Biosciences hat zwei Präsentationen auf der 85. Wissenschaftlichen Tagung der American Diabetes Association angekündigt, die vom 20. bis 23. Juni 2025 in Chicago stattfindet. Die Präsentationen befassen sich mit MBX 1416, einem Glucagon-ähnlichen Peptid-1-Rezeptor-Antagonisten, und stellen dessen Sicherheit, Pharmakokinetik und Pharmakodynamik bei gesunden Probanden in einer Phase-1-Studie sowie seine Wirkung auf den Blutzucker bei Ratten vor. Die Ergebnisse zeigen das Potenzial von MBX 1416 als wöchentliche Behandlung bei postbariatrischer Hypoglykämie (PBH). Das Unternehmen hatte zuvor positive Zwischenergebnisse aus einer Phase-1-SAD/MAD-Studie gemeldet und plant, in der zweiten Hälfte des Jahres 2025 eine Phase-2-Studie zu starten.
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CARMEL, Ind., June 10, 2025 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced presentations at the American Diabetes Association’s (ADA) 85th Scientific Sessions, taking place June 20-23. 2025, Chicago, IL.

  • 846-P - Safety, Pharmacokinetics, and Pharmacodynamics of MBX 1416, a Glucagon-Like Peptide-1 Receptor Antagonist, in Healthy Volunteers: A Phase 1 Randomized Trial
    Presenter: Elisa Fabbrini, MD. PhD.
    Session: General Poster Session
    Date: Sunday June 22nd, 2025
    Time 12:30-1:30pm CT
  • 845-P - MBX 1416, a Selective GLP-1 Antagonist, Elevates and Sustains Blood Glucose in Rats without Change in Body Weight
    Presenter: Richard DiMarchi, PhD.
    Session: General Poster Session
    Date: Sunday June 22nd, 2025
    Time: 12:30-1:30pm CT

The findings presented in the posters demonstrate the mechanism of action of MBX 1416 and illustrate its potential benefits as a once-weekly treatment for post-bariatric hypoglycemia (PBH). MBX announced earlier this year that MBX 1416 demonstrated positive topline results in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy adult volunteers. A Phase 2 trial is expected to be initiated in the second half of 2025.

Following congress publication, the presentations will be available for review on MBX Biosciences publications page https://investors.mbxbio.com/news-events/presentations.

About MBX 1416
MBX 1416 is an investigational long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist in development as a potential treatment for PBH. It was designed using the Company’s novel, proprietary PEP™ platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives.

About Post-bariatric Hypoglycemia
Post-bariatric hypoglycemia (PBH) is a rare and serious complication of bariatric surgery. PBH is characterized by repeated episodes of symptomatic hypoglycemia, triggered by exaggerated secretion of GLP-1 levels following a meal, and can present as early as six months after Roux-en-Y gastric bypass or sleeve gastrectomy. Hypoglycemic episodes can occur multiple times per day and can periodically manifest with severe symptoms, such as dizziness, confusion, loss of consciousness or seizure. The unpredictability of hypoglycemic episodes and their associated risks may meaningfully hinder daily activities. As a result, the patient burden can be substantial, and many individuals cannot drive, work, or live alone. To date, there are no approved pharmacotherapies to treat PBH. As the use of surgery to address metabolic conditions continues to rise, the incidence of PBH is expected to increase, reinforcing the need for safe and effective therapies.

About MBX Biosciences 
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) in Phase 2 development; MBX 1416 for the treatment of post-bariatric hypoglycemia (PBH) in Phase 1 development; and an obesity portfolio that includes MBX 4291, with an IND filing anticipated in Q2 2025, as well as multiple discovery and pre-clinical obesity candidates. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at https://mbxbio.com/ and follow it on LinkedIn.

Media Contact:
Kati Beach Oltsik
Inizio Evoke Comms
katie.beach@inizioevoke.com   
(937) 232-4889

Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com


FAQ

What will MBX Biosciences present at the ADA Scientific Sessions 2025?

MBX will present two posters on MBX 1416: one on its safety and pharmacokinetics in healthy volunteers, and another on its effects on blood glucose in rats.

When is MBX Biosciences starting Phase 2 trials for MBX 1416?

MBX Biosciences plans to initiate Phase 2 trials for MBX 1416 in the second half of 2025.

What is the potential therapeutic use of MBX 1416?

MBX 1416 is being developed as a once-weekly treatment for post-bariatric hypoglycemia (PBH).

What were the results of MBX 1416's Phase 1 trial?

MBX 1416 demonstrated positive topline results in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial in healthy adult volunteers.

When and where will the ADA Scientific Sessions 2025 take place?

The American Diabetes Association's 85th Scientific Sessions will take place from June 20-23, 2025, in Chicago, IL.
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