Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Announces FDA Regulatory Pathway for EL-22, a Pioneering Obesity Therapy Targeting Fat Loss and Muscle Preservation
Elevai Biosciences, a subsidiary of Elevai Labs, has announced a regulatory pathway for EL-22, a pioneering obesity therapy. EL-22, a first-in-class myostatin asset, aims to preserve muscle mass while reducing fat, addressing muscle loss often seen with GLP-1-based treatments. The company plans to file an Investigational New Drug (IND) application with the FDA in 2025.
Elevai is preparing for a pre-IND meeting with the FDA in Q1 2025 to establish the development pathway for EL-22. This meeting will clarify additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission. EL-22 has shown significant physiological and functional improvements in preclinical studies and completed a Phase 1 clinical trial in South Korea, demonstrating safety and tolerability in healthy volunteers.
Leveraging data from their Korean partner, Elevai aims to accelerate the IND process and subsequent U.S. clinical trials, potentially redefining obesity care by combining effective weight loss with muscle preservation.
Elevai Biosciences, una sussidiaria di Elevai Labs, ha annunciato un percorso regolatorio per EL-22, una terapia innovativa per l'obesità. EL-22, un asset di myostatina di prima classe, punta a preservare la massa muscolare riducendo al contempo il grasso, affrontando la perdita muscolare spesso osservata con i trattamenti basati sul GLP-1. L'azienda prevede di presentare un Investigational New Drug (IND) all'FDA nel 2025.
Elevai si sta preparando per un incontro pre-IND con l'FDA nel primo trimestre del 2025 per definire il percorso di sviluppo di EL-22. Questo incontro chiarirà ulteriori requisiti preclinici e aggiustamenti per Chimica, Produzione e Controllo prima della presentazione dell'IND. EL-22 ha mostrato significativi miglioramenti fisiologici e funzionali negli studi preclinici e ha completato uno studio clinico di fase 1 in Corea del Sud, dimostrando sicurezza e tollerabilità in volontari sani.
Sfruttando i dati del loro partner coreano, Elevai punta ad accelerare il processo IND e i successivi trial clinici negli Stati Uniti, con il potenziale di ridefinire la cura dell'obesità combinando una perdita di peso efficace con la preservazione muscolare.
Elevai Biosciences, una subsidiaria de Elevai Labs, ha anunciado un camino regulatorio para EL-22, una terapia pionera contra la obesidad. EL-22, un activo de miosatina de primera clase, tiene como objetivo preservar la masa muscular mientras reduce la grasa, abordando la pérdida muscular que a menudo se observa con los tratamientos basados en GLP-1. La empresa planea presentar una Investigational New Drug (IND) ante la FDA en 2025.
Elevai se está preparando para una reunión pre-IND con la FDA en el primer trimestre de 2025 para establecer el camino de desarrollo para EL-22. Esta reunión aclarará los requisitos preclínicos adicionales y ajustes en Química, Fabricación y Control antes de la presentación del IND. EL-22 ha demostrado mejoras fisiológicas y funcionales significativas en estudios preclínicos y completó un ensayo clínico de fase 1 en Corea del Sur, demostrando seguridad y tolerabilidad en voluntarios sanos.
Aprovechando los datos de su socio coreano, Elevai busca acelerar el proceso del IND y los ensayos clínicos subsecuentes en Estados Unidos, redefiniendo potencialmente la atención de la obesidad al combinar una pérdida de peso efectiva con la preservación muscular.
Elevai Biosciences는 Elevai Labs의 자회사로서 EL-22에 대한 규제 경로를 발표했습니다. EL-22는 근육량을 유지하면서 지방을 줄이는 것을 목표로 하는 최초의 mios타틴 자산으로, GLP-1 기반 치료에서 종종 나타나는 근육 손실 문제를 해결합니다. 회사는 2025년에 FDA에 Investigational New Drug (IND) 신청서를 제출할 계획입니다.
Elevai는 2025년 1분기에 FDA와의 사전 IND 회의를 준비하고 있으며, EL-22의 개발 경로를 확립할 예정입니다. 이 회의에서는 IND 제출 전에 추가적인 전임상 요건 및 화학, 제조 및 관리 조정을 명확히 할 것입니다. EL-22는 전임상 연구에서 상당한 생리적 및 기능적 개선을 보였으며, 한국에서 1상 임상 시험을 완료하여 건강한 자원자들에서 안전성과 내약성을 입증했습니다.
Elevai는 한국 파트너의 데이터를 활용하여 IND 프로세스와 이후 미국에서의 임상 시험을 가속화하고, 효과적인 체중 감량과 근육 보호를 결합하여 비만 치료의 방향을 재정의할 수 있는 가능성을 가지고 있습니다.
Elevai Biosciences, une filiale de Elevai Labs, a annoncé un chemin réglementaire pour EL-22, une thérapie innovante contre l'obésité. EL-22, un actif de myostatine de première classe, vise à préserver la masse musculaire tout en réduisant la graisse, en abordant la perte musculaire souvent observée avec les traitements basés sur le GLP-1. L'entreprise prévoit de soumettre une demande de Investigational New Drug (IND) à la FDA en 2025.
Elevai se prépare à une réunion pré-IND avec la FDA au premier trimestre 2025 pour établir le chemin de développement d'EL-22. Cette réunion clarifiera les exigences précliniques supplémentaires et les ajustements dans la chimie, la fabrication et les contrôles avant la soumission de l'IND. EL-22 a montré des améliorations physiologiques et fonctionnelles significatives dans les études précliniques et a complété un essai clinique de phase 1 en Corée du Sud, démontrant la sécurité et la tolérabilité chez des volontaires sains.
En s'appuyant sur les données de leur partenaire coréen, Elevai vise à accélérer le processus IND et les essais cliniques ultérieurs aux États-Unis, redéfinissant potentiellement les soins d'obésité en combinant une perte de poids efficace avec la préservation musculaire.
Elevai Biosciences, eine Tochtergesellschaft von Elevai Labs, hat einen regulatorischen Weg für EL-22, eine bahnbrechende Therapie gegen Adipositas, angekündigt. EL-22, ein erstklassiger Myostatin-Wirkstoff, zielt darauf ab, die Muskelmasse zu erhalten und gleichzeitig das Fett zu reduzieren, um dem Muskelschwund entgegenzuwirken, der häufig bei GLP-1-basierten Behandlungen auftritt. Das Unternehmen plant, 2025 einen Investigational New Drug (IND) Antrag bei der FDA einzureichen.
Elevai bereitet sich auf ein Pre-IND-Meeting mit der FDA im ersten Quartal 2025 vor, um den Entwicklungsweg für EL-22 festzulegen. In diesem Meeting werden zusätzliche präklinische Anforderungen und Anpassungen in Bezug auf Chemie, Herstellung und Kontrolle vor der IND-Einreichung geklärt. EL-22 hat in präklinischen Studien bedeutende physiologische und funktionale Verbesserungen gezeigt und hat eine Phase-1-Studie in Südkorea abgeschlossen, die Sicherheit und Verträglichkeit bei gesunden Probanden demonstriert hat.
Durch die Nutzung von Daten ihres koreanischen Partners möchte Elevai den IND-Prozess und die anschließenden klinischen Studien in den USA beschleunigen und möglicherweise die Behandlung von Adipositas neu definieren, indem eine effektive Gewichtsreduktion mit dem Erhalt der Muskelmasse kombiniert wird.
- Regulatory pathway for EL-22 announced.
- Plans to file IND application with FDA in 2025.
- Pre-IND meeting with FDA scheduled for Q1 2025.
- EL-22 addresses muscle loss in obesity treatments.
- Preclinical studies show significant improvements.
- Phase 1 clinical trial in South Korea demonstrated safety and tolerability.
- IND application not yet filed, pending pre-IND meeting outcomes.
- Potential delays if additional preclinical requirements are identified.
Insights
- EL-22, a first-in-class myostatin asset, is being developed as a potential combination therapy with GLP-1 receptor agonists for obesity. It aims to address muscle loss, a common side effect of rapid weight loss from GLP-1-based treatments, by preserving muscle mass while reducing fat.
- The company plans to file an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) in 2025.
NEWPORT BEACH, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Elevai Labs Inc. (Nasdaq: ELAB) (“Elevai” or the “Company”), a diversified holding company, subsidiary Elevai Biosciences Inc. (“Elevai Biosciences”), today announced the next steps in its regulatory strategy for EL-22, aimed at treating obesity and preserving muscle mass.
In collaboration with KCRN Research, Inc., the Company is preparing for a pre-IND meeting with the FDA, anticipated in the first quarter of 2025. This meeting will establish the development pathway for EL-22, clarifying any additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission.
EL-22 is an engineered probiotic designed to express myostatin on its surface, leveraging the myostatin pathway to support muscle health. Preclinical studies, including a 2022 study 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.
“Regulatory precedent for myostatin-based therapies in combination with GLP-1 receptor agonists are promising,” said Deniel Mero, Co-founder of Elevai Biosciences. “Leveraging existing data from our Korean licensing partner, including human safety studies, provides a strong foundation to accelerate the IND process and subsequent U.S. clinical trials. We are excited about EL-22’s potential to redefine obesity care by combining effective weight loss with muscle preservation.”
Elevai aims to file the IND in 2025 and thereafter initiate clinical trials to evaluate the combination of EL-22 with GLP-1 receptor agonists for obesity treatment.
About Elevai Labs, Inc.
Elevai Labs Inc. specializes in medical aesthetics and biopharmaceutical drug development, focusing on innovations for skin aesthetics and treatments tied to obesity and metabolic health. The Company operates a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors, Elevai Skincare Inc., Elevai Biosciences Inc., and Elevai Research Inc. For more information please visit www.elevailabs.com.
About Elevai Biosciences
Elevai Biosciences Inc., an Elevai Labs company, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Our 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.elevaibio.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 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 risks and uncertainties include, among others: Elevai’s limited operating history and historical losses; Elevai’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai’s dependence on the success of its product candidates EL-22 and EL-32; that Elevai may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Elevai’s ability to obtain, maintain and protect its intellectual property; Elevai’s dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and Elevai’s expectations regarding its growth, strategy, progress and the design, objectives and timing of its studies. These and other risks are described more fully in Elevai’s filings with the 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@ElevaiLabs.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
What is the regulatory pathway for EL-22 announced by Elevai Biosciences?
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