Northstrive Biosciences Inc. Schedules Pre-IND Meeting with FDA for EL-22, an Obesity Therapy Targeting Fat Loss and Muscle Preservation in Combination with GLP-1
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), has scheduled a pre-IND meeting with the FDA for April 23, 2025 to discuss their novel obesity treatment EL-22. The therapy combines an engineered probiotic approach with GLP-1 receptor agonists, specifically targeting muscle preservation during weight loss.
EL-22 is designed to express myostatin on its surface, aiming to support muscle health through the myostatin pathway. The treatment has shown promising results in preclinical studies, including significant improvements in mdx mice studies published in 2022. Additionally, EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating general tolerability and safety in healthy volunteers.
Following FDA feedback, Northstrive plans to file an Investigational New Drug application in 2025 and begin clinical trials evaluating EL-22's combination with GLP-1 receptor agonists for obesity treatment.
Northstrive Biosciences, una filiale di PMGC Holdings (NASDAQ: ELAB), ha programmato un incontro pre-IND con la FDA per 23 aprile 2025 per discutere del loro nuovo trattamento per l'obesità EL-22. La terapia combina un approccio probiotico ingegnerizzato con agonisti del recettore GLP-1, mirando specificamente alla preservazione muscolare durante la perdita di peso.
EL-22 è progettato per esprimere la miostatina sulla sua superficie, con l'obiettivo di supportare la salute muscolare attraverso la via della miostatina. Il trattamento ha mostrato risultati promettenti in studi preclinici, inclusi miglioramenti significativi negli studi su topi mdx pubblicati nel 2022. Inoltre, EL-22 ha completato uno studio clinico di Fase 1 in Corea del Sud, dimostrando una generale tollerabilità e sicurezza in volontari sani.
In seguito al feedback della FDA, Northstrive prevede di presentare una domanda per un farmaco sperimentale nel 2025 e iniziare studi clinici per valutare la combinazione di EL-22 con agonisti del recettore GLP-1 per il trattamento dell'obesità.
Northstrive Biosciences, una subsidiaria de PMGC Holdings (NASDAQ: ELAB), ha programado una reunión pre-IND con la FDA para 23 de abril de 2025 para discutir su nuevo tratamiento para la obesidad EL-22. La terapia combina un enfoque probiótico ingenierizado con agonistas del receptor GLP-1, enfocándose específicamente en la preservación muscular durante la pérdida de peso.
EL-22 está diseñado para expresar miostatina en su superficie, con el objetivo de apoyar la salud muscular a través de la vía de la miostatina. El tratamiento ha mostrado resultados prometedores en estudios preclínicos, incluidos mejoras significativas en estudios con ratones mdx publicados en 2022. Además, EL-22 ha completado un ensayo clínico de Fase 1 en Corea del Sur, demostrando una tolerabilidad y seguridad generales en voluntarios sanos.
Tras la retroalimentación de la FDA, Northstrive planea presentar una solicitud de Nuevo Medicamento en 2025 y comenzar ensayos clínicos para evaluar la combinación de EL-22 con agonistas del receptor GLP-1 para el tratamiento de la obesidad.
Northstrive Biosciences, PMGC Holdings (NASDAQ: ELAB)의 자회사, 는 2025년 4월 23일에 FDA와의 사전 IND 회의를 예정하고 있으며, 새로운 비만 치료제 EL-22에 대해 논의할 예정입니다. 이 치료법은 엔지니어링된 프로바이오틱 접근법과 GLP-1 수용체 작용제를 결합하여 체중 감소 동안 근육 보존을 목표로 합니다.
EL-22는 표면에 미오스타틴을 발현하도록 설계되어 있으며, 미오스타틴 경로를 통해 근육 건강을 지원하는 것을 목표로 하고 있습니다. 이 치료는 2022년에 발표된 mdx 쥐 연구를 포함한 전임상 연구에서 유망한 결과를 보여주었습니다. 또한, EL-22는 한국에서 1상 임상 시험을 완료하여 건강한 자원자들에서 일반적인 내약성과 안전성을 입증했습니다.
FDA의 피드백에 따라 Northstrive는 2025년에 임상시험용 신약 신청서를 제출하고 비만 치료를 위한 EL-22와 GLP-1 수용체 작용제의 조합을 평가하는 임상 시험을 시작할 계획입니다.
Northstrive Biosciences, une filiale de PMGC Holdings (NASDAQ: ELAB), a prévu une réunion pré-IND avec la FDA pour le 23 avril 2025 afin de discuter de leur nouveau traitement contre l'obésité EL-22. La thérapie combine une approche probiotique ingénierie avec des agonistes des récepteurs GLP-1, ciblant spécifiquement la préservation musculaire pendant la perte de poids.
EL-22 est conçu pour exprimer la myostatine à sa surface, visant à soutenir la santé musculaire via la voie de la myostatine. Le traitement a montré des résultats prometteurs dans des études précliniques, y compris des améliorations significatives dans des études sur des souris mdx publiées en 2022. De plus, EL-22 a complété un essai clinique de phase 1 en Corée du Sud, démontrant une tolérance générale et une sécurité chez des volontaires sains.
Suite aux retours de la FDA, Northstrive prévoit de déposer une demande de médicament expérimental en 2025 et de commencer des essais cliniques évaluant la combinaison d'EL-22 avec des agonistes des récepteurs GLP-1 pour le traitement de l'obésité.
Northstrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), hat ein Pre-IND-Meeting mit der FDA für 23. April 2025 angesetzt, um über ihre neuartige Behandlung von Fettleibigkeit EL-22 zu diskutieren. Die Therapie kombiniert einen ingenieurtechnischen Probiotika-Ansatz mit GLP-1-Rezeptor-Agonisten und zielt speziell darauf ab, die Muskulatur während des Gewichtsverlusts zu erhalten.
EL-22 ist so konzipiert, dass es Myostatin auf seiner Oberfläche exprimiert, um die Muskelgesundheit über den Myostatin-Weg zu unterstützen. Die Behandlung hat in präklinischen Studien vielversprechende Ergebnisse gezeigt, darunter signifikante Verbesserungen in Studien mit mdx-Mäusen, die 2022 veröffentlicht wurden. Darüber hinaus hat EL-22 eine Phase-1-Studie in Südkorea abgeschlossen, die eine allgemeine Verträglichkeit und Sicherheit bei gesunden Freiwilligen demonstrierte.
Nach dem Feedback der FDA plant Northstrive, 2025 einen Antrag auf ein Prüfpräparat einzureichen und klinische Studien zur Bewertung der Kombination von EL-22 mit GLP-1-Rezeptor-Agonisten zur Behandlung von Fettleibigkeit zu beginnen.
- Completed Phase 1 trial showing safety and tolerability
- Positive preclinical results in mdx mice studies
- Advancing towards IND filing in potentially large obesity market
- Novel approach addressing unmet need in GLP-1 weight loss treatments
- Early development stage with no efficacy data in target population
- Regulatory approval pathway still uncertain pending FDA meeting
- Timeline to market launch remains undefined
- Northstrive Biosciences Inc. has scheduled a pre-IND meeting with the U.S. Food and Drug Administration for April 23, 2025.
- EL-22 is leveraging a myostatin-engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
NEWPORT BEACH, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. (“Northstrive”), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (the “Company,” “PMGC,” “we,” or “our”), announced that it has scheduled a pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) for Wednesday, April 23, 2025. Northstrive will have a Type B pre-IND meeting with the FDA to discuss the path forward for filing an IND for EL-22 as a combination treatment with GLP-1 for muscle preservation.
EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the validated myostatin pathway to support muscle health. Preclinical studies, including a 2022 publication in mdx mice (a model of Duchenne muscular dystrophy), demonstrated significant physiological and functional improvements.1 EL-22 has also completed a Phase 1 clinical trial in South Korea, where it was shown to be generally well-tolerated and safe in healthy volunteers.
“The scheduled pre-IND meeting is a crucial step in our development of EL-22 and underscores our commitment to advancing this potential breakthrough therapy,” said Deniel Mero, Co-founder of Northstrive Biosciences. “We expect to walk away from the meeting with a clear path for moving into human trials, targeting one of obesity’s biggest unmet needs; the preservation of muscle for patients on GLP-1 therapies.”
Upon FDA feedback and guidance, Northstrive aims to file the Investigational New Drug application in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment.
About Northstrive Biosciences Inc.
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive’s lead asset, EL-22, is leveraging an engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com.
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. Currently, our portfolio consists of three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC. We are committed to exploring opportunities in multiple sectors to maximize growth and value. For more information, please visit https://www.pmgcholdings.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as “believes,” “expects,” “plans,” “potential,” “would” and “future” or similar expressions such as “look forward” are intended to identify forward-looking statements. Forward-looking statements are made as of the date of this press release and are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results. Therefore, you should not rely on any of these forward-looking statements. These and other risks are described more fully in PMGC Holdings’ filings with the United States Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, and its other documents subsequently filed with or furnished to the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
IR Contact:
IR@pmgcholdings.com
1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
FAQ
When is the FDA pre-IND meeting scheduled for ELAB's EL-22 obesity treatment?
What clinical trials has ELAB's EL-22 completed so far?
How does ELAB's EL-22 work with GLP-1 medications for obesity?
What are the preclinical results for ELAB's EL-22 treatment?
When does ELAB plan to file the IND application for EL-22?
