MBX Biosciences Announces Last Subject Last Visit in Phase 1 Trial of MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia
MBX Biosciences announced the completion of the last subject's last visit in its Phase 1 trial of MBX 1416, a long-acting GLP-1 receptor antagonist for post-bariatric hypoglycemia (PBH) treatment. The randomized, double-blind, placebo-controlled study enrolled 69 participants to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses in healthy adults. The company expects to release topline results in early January 2025. The trial represents a significant milestone in developing a treatment for PBH, a condition currently without approved therapies.
MBX Biosciences ha annunciato il completamento dell'ultimo incontro dell'ultimo soggetto nel suo studio di Fase 1 su MBX 1416, un antagonista del recettore GLP-1 a lunga durata d'azione per il trattamento dell'ipoglicemia post-bariatrica (PBH). Lo studio randomizzato, in doppio cieco e controllato con placebo ha arruolato 69 partecipanti per valutare sicurezza, tollerabilità, farmacocinetica e farmacodinamica di dosi singole e multiple in adulti sani. L'azienda prevede di pubblicare i risultati preliminari all'inizio di gennaio 2025. Lo studio rappresenta un traguardo significativo nello sviluppo di un trattamento per la PBH, una condizione attualmente priva di terapie approvate.
MBX Biosciences anunció la finalización de la última visita del último sujeto en su estudio de Fase 1 de MBX 1416, un antagonista de receptores GLP-1 de acción prolongada para el tratamiento de la hipoglucemia post-bariátrica (PBH). El estudio aleatorizado, doble ciego y controlado con placebo incluyó 69 participantes para evaluar la seguridad, tolerabilidad, farmacocinética y farmacodinamia de dosis únicas y múltiples en adultos sanos. La empresa espera publicar los resultados preliminares a principios de enero de 2025. Este ensayo representa un hito significativo en el desarrollo de un tratamiento para la PBH, una condición actualmente sin terapias aprobadas.
MBX 바이오사이언스는 MBX 1416에 대한 1상 시험에서 마지막 참가자의 마지막 방문이 완료되었다고 발표했습니다. 이는 체중 감량 수술 후 저혈당증(PBH) 치료를 위한 장시간 작용 GLP-1 수용체 길항제입니다. 이 연구는 무작위, 이중 맹검, 위약 대조 연구로 69명의 참가자를 등록하여 건강한 성인을 대상으로 단일 및 다중 상승 용량의 안전성, 내약성, 약동학 및 약력학을 평가했습니다. 회사는 2025년 1월 초에 주요 결과를 발표할 계획입니다. 이 시험은 현재 승인된 치료법이 없는 PBH 치료 개발의 중요한 이정표를 나타냅니다.
MBX Biosciences a annoncé l'achèvement de la dernière visite du dernier participant dans son essai de Phase 1 sur MBX 1416, un antagoniste des récepteurs GLP-1 à action prolongée pour le traitement de l'hypoglycémie post-bariée (PBH). L'étude randomisée, en double aveugle et contrôlée par placebo a inclus 69 participants pour évaluer la sécurité, la tolérance, la pharmacocinétique et la pharmacodynamique de doses uniques et multiples chez des adultes en bonne santé. La société prévoit de publier des résultats préliminaires au début de janvier 2025. Cet essai représente une étape importante dans le développement d'un traitement pour la PBH, une condition actuellement sans thérapies approuvées.
MBX Biosciences gab bekannt, dass der letzte Besuch des letzten Probanden in seiner Phase 1 Studie zu MBX 1416 abgeschlossen ist. Dies ist ein langwirkender GLP-1 Rezeptor-Antagonist zur Behandlung von post-bariatrischer Hypoglykämie (PBH). Die randomisierte, doppelblinde, placebo-kontrollierte Studie umfasste 69 Teilnehmer, um die Sicherheit, Verträglichkeit, Pharmakokinetik und Pharmakodynamik von einzelnen und mehrfach ansteigenden Dosen bei gesunden Erwachsenen zu evaluieren. Das Unternehmen erwartet, die Ergebnisse in den frühen Januar 2025 zu veröffentlichen. Die Studie stellt einen bedeutenden Meilenstein in der Entwicklung einer Behandlung für PBH dar, einer Bedingung, die derzeit ohne zugelassene Therapien auskommt.
- Successful completion of Phase 1 trial last visit milestone
- Study enrolled target of 69 participants
- Addresses unmet medical need with no current approved therapies for PBH
- None.
Insights
The completion of Phase 1 trial enrollment for MBX 1416 marks a important development in addressing post-bariatric hypoglycemia (PBH), an underserved medical condition. The study's robust design with 69 participants in a randomized, double-blind, placebo-controlled format strengthens its scientific validity.
MBX 1416's mechanism as a GLP-1 receptor antagonist represents an innovative approach to treating PBH. Current PBH management relies on dietary modifications and off-label medications, making this potential first-in-class therapy particularly significant. The focus on both single and multiple ascending doses will provide comprehensive safety and pharmacokinetic data essential for determining optimal dosing strategies.
The study's completion on schedule indicates strong operational execution, though investors should note that full efficacy assessment will require future Phase 2 trials. The January 2025 timeline for topline results positions MBX for potential advancement in their clinical program by mid-2025 if the data proves favorable.
Topline results expected in early January 2025
CARMEL, Ind., Nov. 18, 2024 (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 the completion of the last subject’s last visit in its Phase 1 single and multiple ascending dose trial of MBX 1416, the Company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist in development for the treatment of post-bariatric hypoglycemia (PBH).
“We are pleased to complete the last subject visit in our Phase 1 trial of MBX 1416 in healthy adults and extend our sincere appreciation to the participants, investigators and clinical team for their support,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “This achievement is a significant milestone in our MBX 1416 program, bringing us closer to treating patients with PBH, for which there are no approved therapies. We look forward to sharing full-topline results in early January 2025.”
The Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 1416 in healthy adult participants. The trial is being conducted in the United States and enrolled a total of 69 participants. The primary endpoint is safety and tolerability, and secondary endpoints include pharmacokinetics and pharmacodynamics. More information on the Phase 1 study can be found at www.clinicaltrials.gov, identifier NCT06036784.
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 (RYGB) 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 its lead product candidate MBX 2109, in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX’s Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences’ expectations regarding the Phase 1 trial of MBX 1416, including the timing of topline results and statements relating to the ability of MBX 1416 to treat patients with PBH.
Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; uncertainties relating to preclinical and clinical development activities; the risk that preliminary results may not be indicative of later results; the Company’s dependence on third parties to conduct clinical trials; MBX Biosciences’ ability to attract, integrate and retain key personnel; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; as well as other risks described in “Risk Factors,” in MBX Biosciences’ Registration Statement on Form S-1 filed with the Securities and Exchange Commission (SEC), most recent Quarterly Report on Form 10-Q, as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
MBX uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Media Contact:
Kate Burdick
Inizio Evoke Comms
kate.burdick@inizioevoke.com
860-462-1569
Investor Contact:
Jim DeNike
MBX Biosciences
jdenike@mbxbio.com
FAQ
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