NorthStrive Biosciences Announces Completion of Phase I Strategic Review for EL-22 Targeting Muscle Loss Associated with GLP-1 Weight Loss Drugs and Age-Related Sarcopenia
NorthStrive Biosciences, a subsidiary of PMGC Holdings (NASDAQ: ELAB), has completed Phase I strategic review of EL-22, their oral myostatin-engineered probiotic. The study, conducted with Yuva Biosciences using their MitoNova™ AI technology, focused on EL-22's potential to combat muscle loss associated with GLP-1 weight loss drugs and age-related sarcopenia.
EL-22 uses genetically engineered Lactobacillus casei to stimulate the gut immune system against myostatin, a muscle growth inhibitor. The preclinical studies in mdx mice showed promising effects on antibody production, serum CK, body weight, motor function, and muscle histology. The company plans to initiate a Phase 2 proof-of-concept trial targeting GLP-1 users and pursue IND filing in the United States.
NorthStrive Biosciences, una controllata di PMGC Holdings (NASDAQ: ELAB), ha completato la revisione strategica di Fase I di EL-22, il loro probiotico orale ingegnerizzato per la miostatina. Lo studio, condotto con Yuva Biosciences utilizzando la tecnologia AI MitoNova™, si è concentrato sul potenziale di EL-22 nel contrastare la perdita muscolare associata ai farmaci GLP-1 per la perdita di peso e alla sarcopenia legata all'età.
EL-22 utilizza Lactobacillus casei geneticamente modificato per stimolare il sistema immunitario intestinale contro la miostatina, un inibitore della crescita muscolare. Gli studi preclinici su topi mdx hanno mostrato effetti promettenti sulla produzione di anticorpi, CK sierica, peso corporeo, funzione motoria e istologia muscolare. L'azienda prevede di avviare una prova di concetto di Fase 2 rivolta agli utilizzatori di GLP-1 e di procedere con la presentazione dell'IND negli Stati Uniti.
NorthStrive Biosciences, una subsidiaria de PMGC Holdings (NASDAQ: ELAB), ha completado la revisión estratégica de Fase I de EL-22, su probiótico oral modificado para la miostatina. El estudio, realizado junto con Yuva Biosciences utilizando la tecnología de IA MitoNova™, se centró en el potencial de EL-22 para combatir la pérdida muscular asociada con los medicamentos para la pérdida de peso GLP-1 y la sarcopenia relacionada con la edad.
EL-22 emplea Lactobacillus casei genéticamente modificado para estimular el sistema inmunológico intestinal contra la miostatina, un inhibidor del crecimiento muscular. Los estudios preclínicos en ratones mdx mostraron efectos prometedores en la producción de anticuerpos, CK sérica, peso corporal, función motora e histología muscular. La compañía planea iniciar un ensayo de prueba de concepto de Fase 2 dirigido a usuarios de GLP-1 y buscar la presentación de IND en Estados Unidos.
NorthStrive Biosciences는 PMGC Holdings (NASDAQ: ELAB)의 자회사로서 경구용 미오스타틴 조작 프로바이오틱인 EL-22의 1상 전략 검토를 완료했습니다. Yuva Biosciences와 함께 MitoNova™ AI 기술을 활용해 진행된 이번 연구는 GLP-1 체중 감량 약물 및 연령 관련 근감소증과 관련된 근육 손실을 방지하는 EL-22의 잠재력에 중점을 두었습니다.
EL-22는 유전자 조작된 Lactobacillus casei를 사용하여 근육 성장 억제제인 미오스타틴에 대해 장내 면역 시스템을 자극합니다. mdx 생쥐를 대상으로 한 전임상 연구에서 항체 생성, 혈청 CK, 체중, 운동 기능 및 근육 조직학에 유망한 효과가 나타났습니다. 회사는 GLP-1 사용자들을 대상으로 한 2상 개념 증명 시험을 시작하고 미국에서 IND 신청을 추진할 계획입니다.
NorthStrive Biosciences, une filiale de PMGC Holdings (NASDAQ : ELAB), a achevé la revue stratégique de phase I de EL-22, leur probiotique oral modifié pour la myostatine. L'étude, réalisée avec Yuva Biosciences en utilisant leur technologie d'IA MitoNova™, s'est concentrée sur le potentiel d'EL-22 à lutter contre la perte musculaire associée aux médicaments GLP-1 pour la perte de poids et à la sarcopénie liée à l'âge.
EL-22 utilise un Lactobacillus casei génétiquement modifié pour stimuler le système immunitaire intestinal contre la myostatine, un inhibiteur de la croissance musculaire. Les études précliniques chez des souris mdx ont montré des effets prometteurs sur la production d'anticorps, la CK sérique, le poids corporel, la fonction motrice et l'histologie musculaire. La société prévoit de lancer un essai de preuve de concept de phase 2 ciblant les utilisateurs de GLP-1 et de déposer un dossier IND aux États-Unis.
NorthStrive Biosciences, eine Tochtergesellschaft von PMGC Holdings (NASDAQ: ELAB), hat die strategische Überprüfung der Phase I für EL-22, ihren oral verabreichten, gentechnisch veränderten Myostatin-Probiotikum, abgeschlossen. Die Studie, die in Zusammenarbeit mit Yuva Biosciences unter Verwendung der MitoNova™ KI-Technologie durchgeführt wurde, konzentrierte sich auf das Potenzial von EL-22, dem mit GLP-1-Gewichtsverlustmedikamenten und altersbedingter Sarkopenie verbundenen Muskelschwund entgegenzuwirken.
EL-22 verwendet gentechnisch veränderte Lactobacillus casei, um das Darmimmunsystem gegen Myostatin, einen Muskelwachstumshemmer, zu stimulieren. Die präklinischen Studien an mdx-Mäusen zeigten vielversprechende Effekte auf Antikörperproduktion, Serum-CK, Körpergewicht, motorische Funktionen und Muskelhistologie. Das Unternehmen plant die Einleitung einer Phase-2-Wirksamkeitsstudie, die sich an GLP-1-Nutzer richtet, sowie die Einreichung eines IND-Antrags in den USA.
- Novel oral delivery approach using engineered probiotics, offering potential advantages over traditional injectable antibodies
- Strong preclinical results in mdx mice showing positive effects on multiple parameters
- Strategic positioning to address growing market of GLP-1 associated muscle loss
- Clear development pathway with planned Phase 2 trial and IND filing
- Still in early stages with only Phase I strategic review completed
- No human clinical data available yet
- Regulatory approval pathway uncertainty for novel probiotic-based therapy
Insights
NorthStrive's EL-22 shows promising preclinical results for addressing muscle loss from GLP-1 drugs, preparing to advance to Phase 2 trials.
NorthStrive Biosciences has completed a Phase I strategic review of their novel oral myostatin-engineered probiotic EL-22, positioning themselves in a potentially lucrative niche within the rapidly expanding GLP-1 market. This review represents early-stage progress in their clinical development pathway rather than actual human clinical trial data.
The company's approach is scientifically distinctive in two key aspects. First, they're targeting myostatin—a protein that naturally inhibits muscle growth—using an immunological mechanism rather than direct inhibition. Second, they're utilizing genetically modified Lactobacillus casei bacteria as an oral delivery system to stimulate gut immunity, potentially offering significant advantages over injectable alternatives in both patient convenience and safety profile.
What makes this particularly timely is their focus on GLP-1-associated muscle atrophy. As GLP-1 receptor agonists like semaglutide (Wegovy/Ozempic) and tirzepatide (Mounjaro) continue their explosive market growth, clinicians are increasingly concerned about the significant muscle loss accompanying fat reduction. A companion therapy that preserves lean mass would address a critical unmet need in this
The preclinical data from mdx mice (a muscular dystrophy model) suggests efficacy across multiple parameters including antibody production, serum CK levels, motor function, and muscle histology. However, investors should note this remains early-stage; the company is only now planning their Phase 2 proof-of-concept trial and beginning regulatory engagement for an IND filing. Meaningful clinical data in humans taking GLP-1s is still likely 12-24 months away.
NEWPORT BEACH, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Northstrive Biosciences Inc. (“Northstrive”), a subsidiary of PMGC Holdings Inc. (NASDAQ: ELAB) (the “Company,” “PMGC,” “we,” or “our”), today announced the completion of a Phase I strategic research and literature synthesis for EL-22 (formerly BLS-M22), its first-in-class oral myostatin-engineered probiotic. The analysis, conducted in collaboration with Yuva Biosciences and supported by AI-based scientific review technology from Yuva Biosciences’ MitoNova™, provided valuable insights into EL-22’s proposed mechanism of action and will help guide further exploration into its potential to address critical unmet needs in muscle-wasting conditions, including GLP-1-associated atrophy and age-related sarcopenia.
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. The oral biologic is designed to induce a targeted immune response against myostatin, a key negative regulator of muscle growth. Unlike traditional injectable antibodies, EL-22 leverages genetically engineered Lactobacillus casei to stimulate the gut immune system, offering a convenient, patient-friendly oral delivery method with potential safety and efficacy advantages.
Key Highlights from the Report:
- Strong Preclinical Rationale: Synthesized findings from published peer-reviewed literature, highlight noteworthy effects of EL-22 in mdx mice on antibody production, serum CK, body weight, motor function, and muscle histology.
- Unique Oral Vaccine Approach: EL-22 is distinct from the more common systemic administration of antibodies or gene therapy vectors. Utilizing Lactobacillus casei as a delivery vehicle to stimulate mucosal and systemic immunity against myostatin is a novel immunological strategy for a muscle-wasting disorder.
- Targeting GLP-1-Associated Muscle Loss: With the rapid expansion of GLP-1 receptor agonists in obesity and diabetes, EL-22 is well-positioned to address the growing concern of associated muscle loss. The company is prioritizing this indication for its next clinical development milestone.
- Strategic Next Steps: NorthStrive intends to launch a Phase 2 proof-of-concept trial targeting GLP-1 users and begin regulatory engagement to advance EL-22 toward an IND filing in the United States.
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, 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 Yuva Biosciences, Inc.
Yuva Biosciences is a longevity company harnessing the cutting edge of mitochondrial science to address the root cause of aging. By partnering with consumer brands and biotech innovators, Yuva Biosciences develops solutions for aging-related concerns including hair loss, skin wrinkles, and several other conditions driven by a decline in mitochondrial function. The company is headquartered in Birmingham, Alabama. For more information, please visit www.yuvabio.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’s 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, 2024, filed with the SEC on March 28, 2025, 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
FAQ
What is EL-22 and how does it work to prevent muscle loss?
What are the key findings from ELAB's Phase I strategic review of EL-22?
How does NorthStrive's EL-22 differ from traditional muscle loss treatments?
What are the next steps for ELAB's EL-22 development program?
Why is ELAB focusing on GLP-1-associated muscle loss for EL-22?
