Northstrive Biosciences Inc., a Subsidiary of PMGC Holdings Inc., Announces Successful Submission of Pre-IND Meeting Request to FDA for EL-22, a Potential Breakthrough Obesity Therapy Targeting Fat Loss and Muscle Preservation in Combination with GLP-1 Receptor Agonists
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), has submitted a pre-IND meeting request to the FDA for EL-22, a novel myostatin-targeting therapy designed to preserve muscle during weight loss treatments. The company expects a Type B pre-IND meeting with the FDA in Q2 2025 to discuss nonclinical studies and clinical development plans for EL-22's use in combination with GLP-1 receptor agonists for obesity treatment.
EL-22 is a patent-pending engineered probiotic that expresses myostatin on its surface. Preclinical studies in mdx mice showed significant physiological and functional improvements, and a Phase 1 trial in South Korea demonstrated general safety and tolerability in healthy volunteers. The company plans to file an IND application in 2025 to begin clinical trials evaluating EL-22's combination with GLP-1 receptor agonists.
Northstrive Biosciences, una sussidiaria di PMGC Holdings (NASDAQ: ELAB), ha presentato una richiesta di incontro pre-IND alla FDA per EL-22, una nuova terapia mirata al miostatina progettata per preservare la massa muscolare durante i trattamenti di perdita di peso. L'azienda prevede un incontro pre-IND di Tipo B con la FDA nel secondo trimestre del 2025 per discutere studi non clinici e piani di sviluppo clinico per l'uso di EL-22 in combinazione con agonisti del recettore GLP-1 per il trattamento dell'obesità.
EL-22 è un probiotico ingegnerizzato in attesa di brevetto che esprime miostatina sulla sua superficie. Gli studi preclinici su topi mdx hanno mostrato significativi miglioramenti fisiologici e funzionali, e uno studio di Fase 1 in Corea del Sud ha dimostrato sicurezza generale e tollerabilità in volontari sani. L'azienda prevede di presentare una domanda IND nel 2025 per avviare studi clinici che valutino la combinazione di EL-22 con agonisti del recettore GLP-1.
Northstrive Biosciences, una subsidiaria de PMGC Holdings (NASDAQ: ELAB), ha presentado una solicitud de reunión pre-IND a la FDA para EL-22, una nueva terapia dirigida a la miostatina diseñada para preservar el músculo durante los tratamientos de pérdida de peso. La compañía espera una reunión pre-IND Tipo B con la FDA en el segundo trimestre de 2025 para discutir estudios no clínicos y planes de desarrollo clínico para el uso de EL-22 en combinación con agonistas del receptor GLP-1 para el tratamiento de la obesidad.
EL-22 es un probiótico ingenierizado pendiente de patente que expresa miostatina en su superficie. Los estudios preclínicos en ratones mdx mostraron mejoras fisiológicas y funcionales significativas, y un ensayo de Fase 1 en Corea del Sur demostró seguridad general y tolerabilidad en voluntarios sanos. La compañía planea presentar una solicitud IND en 2025 para comenzar ensayos clínicos que evalúen la combinación de EL-22 con agonistas del receptor GLP-1.
Northstrive Biosciences는 PMGC Holdings (NASDAQ: ELAB)의 자회사로서 EL-22에 대한 FDA의 사전 IND 회의 요청을 제출했습니다. EL-22는 체중 감소 치료 중 근육을 보존하기 위해 설계된 새로운 미오스타틴 표적 치료제입니다. 회사는 비만 치료를 위해 GLP-1 수용체 작용제와의 병용 사용에 대한 비임상 연구와 임상 개발 계획을 논의하기 위해 2025년 2분기에 FDA와의 B형 사전 IND 회의를 기대하고 있습니다.
EL-22는 표면에 미오스타틴을 발현하는 특허 출원 중인 엔지니어링 프로바이오틱스입니다. mdx 쥐에서의 전임상 연구는 유의미한 생리학적 및 기능적 개선을 보여주었고, 한국에서의 1상 시험은 건강한 자원자들에서 일반적인 안전성과 내약성을 입증했습니다. 회사는 EL-22와 GLP-1 수용체 작용제의 조합을 평가하는 임상 시험을 시작하기 위해 2025년에 IND 신청서를 제출할 계획입니다.
Northstrive Biosciences, une filiale de PMGC Holdings (NASDAQ: ELAB), a soumis une demande de réunion pré-IND à la FDA pour EL-22, une nouvelle thérapie ciblant la myostatine conçue pour préserver le muscle pendant les traitements de perte de poids. L'entreprise prévoit une réunion pré-IND de type B avec la FDA au deuxième trimestre de 2025 pour discuter des études non cliniques et des plans de développement clinique pour l'utilisation d'EL-22 en combinaison avec des agonistes des récepteurs GLP-1 pour le traitement de l'obésité.
EL-22 est un probiotique ingénieré en attente de brevet qui exprime de la myostatine à sa surface. Des études précliniques sur des souris mdx ont montré des améliorations physiologiques et fonctionnelles significatives, et un essai de phase 1 en Corée du Sud a démontré une sécurité générale et une tolérance chez des volontaires sains. L'entreprise prévoit de soumettre une demande IND en 2025 pour commencer des essais cliniques évaluant la combinaison d'EL-22 avec des agonistes des récepteurs GLP-1.
Northstrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), hat einen Antrag auf ein vorläufiges IND-Meeting bei der FDA für EL-22 eingereicht, eine neuartige Therapie, die auf Myostatin abzielt und entwickelt wurde, um Muskeln während der Gewichtsreduktion zu erhalten. Das Unternehmen erwartet ein Typ B vorläufiges IND-Meeting mit der FDA im 2. Quartal 2025, um nichtklinische Studien und klinische Entwicklungspläne für die Anwendung von EL-22 in Kombination mit GLP-1-Rezeptor-Agonisten zur Behandlung von Fettleibigkeit zu besprechen.
EL-22 ist ein patentiertes, ingenieurtechnisch entwickeltes Probiotikum, das Myostatin an seiner Oberfläche exprimiert. Präklinische Studien an mdx-Mäusen zeigten signifikante physiologische und funktionelle Verbesserungen, und eine Phase-1-Studie in Südkorea bestätigte die allgemeine Sicherheit und Verträglichkeit bei gesunden Freiwilligen. Das Unternehmen plant, 2025 einen IND-Antrag einzureichen, um klinische Studien zur Evaluierung der Kombination von EL-22 mit GLP-1-Rezeptor-Agonisten zu beginnen.
- Phase 1 trial in South Korea demonstrated safety and tolerability
- Preclinical studies showed significant improvements in mdx mice
- FDA meeting expected in Q2 2025 to advance development
- Long regulatory pathway ahead before potential commercialization
- Additional clinical trials required to prove efficacy
- Success in combination with GLP-1 agonists not yet demonstrated
Insights
The pre-IND meeting request for EL-22 marks a pivotal development in the $175 billion obesity therapeutics market. This strategic move targets a critical gap in current GLP-1 treatments - the preservation of lean muscle mass during weight loss. The myostatin pathway inhibition approach is particularly noteworthy, as muscle loss during GLP-1 therapy remains a significant concern for healthcare providers and patients.
The existing safety data from South Korea's Phase 1 trial provides a important advantage, potentially accelerating the regulatory pathway. However, the combination therapy approach with GLP-1s introduces additional complexity to the approval process, requiring careful consideration of drug-drug interactions and specific safety protocols.
The timing of this development is particularly strategic, coinciding with the explosive growth of GLP-1 medications. EL-22's potential as a complementary therapy could address a significant market need, as current estimates suggest that up to 30% of weight loss from GLP-1 agonists comes from lean muscle mass.
Manufacturing considerations, including the search for a cGMP partner, suggest proactive preparation for clinical trials, though this could be a critical rate-limiting step in the development timeline. The company's target for IND filing in 2025 appears ambitious but achievable, contingent upon favorable FDA feedback and successful establishment of manufacturing capabilities.
The engineered probiotic approach for myostatin expression represents an innovative delivery mechanism, potentially offering advantages in production scalability and cost-effectiveness compared to traditional biologics. The preliminary efficacy signals from mdx mice studies provide encouraging support for the mechanism of action, though translation to human obesity treatment remains to be validated.
- Northstrive Biosciences Inc. (“Northstrive Biosciences”) has submitted a pre-Investigational New Drug (“pre-IND”) meeting request to the U.S. Food and Drug Administration (“FDA”) for EL-22, a novel myostatin asset aimed at preserving muscle while on weight loss treatments.
- A pre-IND meeting with the FDA is expected in Q2 2025 to discuss nonclinical studies and Northstrive Biosciences’ clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists being used in obese patients.
NEWPORT BEACH, Calif., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences, a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (“PMGC,” “we,” or “our”), announced the submission of a pre-IND meeting request to the FDA. Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second fiscal quarter of 2025.
Northstrive Biosciences seeks guidance from the FDA on the acceptability of the nonclinical studies conducted to date and the clinical development plans for EL-22 administered in combination with GLP-1 receptor agonists being used to treat subjects that are overweight or obese. The FDA is expected to respond to the pre-IND meeting request within the first fiscal quarter of 2025. If this request is granted, the FDA’s response letter will permit a meeting scheduled for the second fiscal quarter of 2025.
“While we wait for the FDA’s response to our meeting request, we have begun working on the meeting package that will outline our regulatory plans," said Deniel Mero, Co-founder of Northstrive Biosciences. “Concurrently, we’re also arranging our manufacturing, including seeking a cGMP partner, to lay the groundwork for the EL-22 Investigational New Drug.”
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 A Phase 1 clinical trial has also been conducted on EL-22 in South Korea, which demonstrated that EL-22 was generally well-tolerated and safe in healthy volunteers.
Upon regulatory confirmation, Northstrive Biosciences 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
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Northstrive Biosciences’ lead asset, EL-22, leverages 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.
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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
What is the purpose of EL-22 in ELAB's obesity treatment development?
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