Northstrive Biosciences, Inc., a Subsidiary of PMGC Holdings Inc., Reports Positive Updates for Obesity Drug Candidates Targeting Fat Loss and Muscle Preservation used in Combination with GLP-1
Northstrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), provided updates on its obesity drug candidates EL-22 and EL-32, designed to optimize fat loss while preserving muscle mass during weight loss therapies, including GLP-1 receptor agonists.
The company is preparing for a pre-IND meeting with the FDA in Q2 2025 for EL-22, a myostatin-engineered probiotic that has completed Phase 1 trials in South Korea showing general safety. Northstrive is currently seeking a U.S.-based cGMP manufacturing partner and aims to file an IND application in 2025.
For EL-32, a pre-clinical engineered probiotic expressing dual myostatin & activin-A inhibitors, Northstrive has engaged a CRO to conduct studies evaluating its effectiveness both alone and in combination with semaglutide in diet-induced obese mice.
Northstrive Biosciences, una controllata di PMGC Holdings (NASDAQ: ELAB), ha fornito aggiornamenti sui suoi candidati farmaci contro l'obesità, EL-22 e EL-32, progettati per ottimizzare la perdita di grasso mantenendo la massa muscolare durante le terapie di perdita di peso, inclusi gli agonisti del recettore GLP-1.
L'azienda si sta preparando per un incontro preliminare IND con la FDA nel secondo trimestre del 2025 per EL-22, un probiotico ingegnerizzato per la miostatina che ha completato le fasi di prova 1 in Corea del Sud mostrando una sicurezza generale. Northstrive sta attualmente cercando un partner per la produzione cGMP negli Stati Uniti e intende presentare una domanda IND nel 2025.
Per EL-32, un probiotico ingegnerizzato preclinico che esprime inibitori della miostatina e dell'attivina-A, Northstrive ha coinvolto un CRO per condurre studi che valutano la sua efficacia sia da solo che in combinazione con semaglutide in topi obesi indotti da dieta.
Northstrive Biosciences, una filial de PMGC Holdings (NASDAQ: ELAB), proporcionó actualizaciones sobre sus candidatos a fármacos para la obesidad, EL-22 y EL-32, diseñados para optimizar la pérdida de grasa mientras se preserva masa muscular durante las terapias de pérdida de peso, incluidos los agonistas del receptor GLP-1.
La empresa se está preparando para una reunión previa a la IND con la FDA en el segundo trimestre de 2025 para EL-22, un probiótico ingenierizado para la miostatina que ha completado ensayos de Fase 1 en Corea del Sur, mostrando seguridad general. Northstrive está buscando actualmente un socio de fabricación cGMP con sede en EE.UU. y tiene como objetivo presentar una solicitud IND en 2025.
Para EL-32, un probiótico ingenierizado preclínico que expresa inhibidores de miostatina y activina-A, Northstrive ha contratado a un CRO para realizar estudios que evalúan su efectividad tanto sola como en combinación con semaglutida en ratones obesos inducidos por dieta.
Northstrive Biosciences, PMGC Holdings의 자회사(NASDAQ: ELAB), 비만 약물 후보인 EL-22와 EL-32에 대한 최신 정보를 제공했습니다. 이들은 체중 감소 치료 중 근육량을 유지하면서 지방 손실을 최적화하도록 설계되었습니다. 여기에는 GLP-1 수용체 작용제도 포함됩니다.
회사는 EL-22를 위해 2025년 2분기에 FDA와의 사전 IND 회의를 준비하고 있으며, 이는 안전성을 보여주는 1상 시험을 완료한 미오스타틴 엔지니어링 프로바이오틱스입니다. Northstrive는 현재 미국 내 cGMP 제조 파트너를 찾고 있으며, 2025년에 IND 신청서를 제출할 계획입니다.
EL-32의 경우, 이중 미오스타틴과 악티빈-A 억제제를 발현하는 전임상 엔지니어링 프로바이오틱스에 대해 Northstrive는 식이유도 비만 쥐에서 독립적으로 또는 세마글루타이드와의 조합으로 효과를 평가하는 연구를 수행하기 위해 CRO를 참여시켰습니다.
Northstrive Biosciences, une filiale de PMGC Holdings (NASDAQ: ELAB), a fourni des mises à jour sur ses candidats médicaments contre l'obésité, EL-22 et EL-32, conçus pour optimiser la perte de graisse tout en préservant la masse musculaire lors des thérapies de perte de poids, y compris les agonistes du récepteur GLP-1.
L'entreprise se prépare à une réunion pré-IND avec la FDA au deuxième trimestre de 2025 pour EL-22, un probiotique conçu pour la myostatine qui a terminé les essais de phase 1 en Corée du Sud avec une sécurité générale. Northstrive est actuellement à la recherche d'un partenaire de fabrication cGMP basé aux États-Unis et prévoit de soumettre une demande IND en 2025.
Pour EL-32, un probiotique ingénierisé préclinique exprimant des inhibiteurs de myostatine et d'activine-A, Northstrive a engagé un CRO pour effectuer des études évaluant son efficacité à la fois seul et en combinaison avec la sémaglutide chez des souris obèses induites par un régime alimentaire.
Northstrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), hat Aktualisierungen zu seinen Adipositas-Arzneikandidaten EL-22 und EL-32 bereitgestellt, die entwickelt wurden, um den Fettverlust zu optimieren und gleichzeitig die Muskelmasse während der Gewichtsreduktions-Therapien, einschließlich GLP-1-Rezeptor-Agonisten, zu erhalten.
Das Unternehmen bereitet sich auf ein Pre-IND-Meeting mit der FDA im 2. Quartal 2025 für EL-22 vor, ein myostatin-engineered Probiotikum, das die Phase-1-Studien in Südkorea abgeschlossen hat und allgemeine Sicherheit zeigt. Northstrive sucht derzeit nach einem cGMP-Herstellungspartner in den USA und plant, 2025 einen IND-Antrag einzureichen.
Für EL-32, ein präklinisches, ingenieured Probiotikum, das duale Myostatin- und Activin-A-Inhibitoren exprimiert, hat Northstrive einen CRO beauftragt, Studien durchzuführen, die seine Wirksamkeit sowohl alleine als auch in Kombination mit Semaglutid bei diätinduzierter Adipositas bei Mäusen bewerten.
- EL-22 has completed Phase 1 clinical trials in South Korea with positive safety results
- FDA pre-IND meeting scheduled for Q2 2025
- Preclinical studies of EL-22 showed significant improvements in mdx mice
- Company has existing data from Korean licensing partner to accelerate pre-IND process
- Products still in early development stages with no proven efficacy in humans for obesity treatment
- Manufacturing partner for EL-22 not yet secured
- EL-32 still in preclinical phase requiring substantial development before human trials
Insights
Northstrive's development progress represents a potentially significant advancement in the $100+ billion obesity treatment market. Their approach targeting muscle preservation during weight loss therapy addresses a critical unmet need, as studies show up to 25-30% of weight loss from GLP-1 agonists can come from muscle mass reduction.
The company's strategy offers several compelling advantages: 1) Their engineered probiotic platform potentially enables oral delivery, contrasting with traditional injectable muscle-preservation therapies, 2) Existing Phase 1 safety data from South Korea could accelerate the regulatory timeline, potentially saving 12-18 months of development time and millions in costs, 3) The dual inhibition approach of EL-32 targeting both myostatin and activin-A pathways could provide superior efficacy compared to single-target competitors.
Key near-term catalysts include:
- Q2 2025 FDA pre-IND meeting for EL-22
- Planned IND filing in 2025
- Preclinical data from EL-32 combination study with semaglutide
However, investors should note certain risks: the novel probiotic delivery platform may face additional regulatory scrutiny and successful translation of Korean safety data to FDA standards isn't guaranteed. Competition in the obesity space is intensifying, with several major pharma companies developing muscle-preservation approaches.
The market opportunity is substantial - analysts project the GLP-1 market to exceed $150 billion by 2030, with muscle preservation becoming an increasingly important consideration for prescribers and patients. A successful complementary therapy could capture significant market share.
- Lead asset 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.
- Northstrive Biosciences Inc. is preparing the necessary steps to leverage existing EL-22 animal data and human safety studies from Korean licensing partner to arrange an Investigational New Drug filing with the U.S. Food and Drug Administration.
- EL-32 is a pre-clinical, engineered probiotic expressing dual myostatin & activin-A, focusing on two clinically validated targets that play an important role in regulating muscle.
NEWPORT BEACH, Calif., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. ("Northstrive"), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) ("PMGC," "we," or "our"), announced an update for its innovative obesity treatment candidates, EL-22 and EL-32, both aimed at optimizing fat loss while preserving muscle mass in patients undergoing weight loss therapies, including GLP-1 receptor agonists.
EL-22: Preparing for FDA Pre-IND Meeting Request
Northstrive is finalizing preparations for a pre-Investigational New Drug ("pre-IND") meeting request with the U.S. Food and Drug Administration ("FDA"). Northstrive anticipates having a Type B pre-IND meeting with the FDA in the second quarter of 2025. Northstrive has completed necessary translations and compiled preclinical and clinical inquiries from existing data from its South Korean licensing partner to support the meeting request. Concurrently, Northstrive is seeking a U.S.-based Current Good Manufacturing Practices (cGMP) manufacturing partner for EL-22.
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.
Upon regulatory confirmation, 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.
EL-32: Engaged CRO for Preclinical Study
Northstrive has entered into a research agreement with a leading preclinical contract research organization (CRO) specializing in metabolic disorders. The research agreement will support a planned study to evaluate EL-32, an engineered probiotic expressing dual myostatin and activin-A inhibitors, both as a monotherapy and in combination with the GLP-1 receptor agonist semaglutide. The focus of the study will be on glycemic control and body composition in diet-induced obese (DIO) mice.
"We are laying the groundwork to move both programs forward as potential treatments for obesity," said Deniel Mero, Co-founder of Northstrive Biosciences. "The FDA has cleared other myostatin-based therapies to start clinical trials in combination with GLP-1 receptor agonists, which gives us confidence and a precedent to follow a similar path by leveraging existing data from our Korean licensing partner to accelerate our pre-IND process."
Upcoming Presentation
Northstrive will present its novel obesity drug candidates at the exclusive UCLA Obesity Symposium, "Anti-Obesity Treatments: Challenges and Emerging Solutions," organized by the UCLA Metabolism Theme, an initiative of the UCLA David Geffen School of Medicine. The presentation, titled "Myostatin-Engineered L. Casei Bacteria As A Muscle Preserving Therapeutic," is scheduled for Friday, February 7, 2025.
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'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.
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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
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