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'obesit脿. 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 chiarir脿 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 tollerabilit脿 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'obesit脿 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 p茅rdida 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 est谩 preparando para una reuni贸n pre-IND con la FDA en el primer trimestre de 2025 para establecer el camino de desarrollo para EL-22. Esta reuni贸n aclarar谩 los requisitos precl铆nicos adicionales y ajustes en Qu铆mica, Fabricaci贸n y Control antes de la presentaci贸n del IND. EL-22 ha demostrado mejoras fisiol贸gicas y funcionales significativas en estudios precl铆nicos y complet贸 un ensayo cl铆nico 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 cl铆nicos subsecuentes en Estados Unidos, redefiniendo potencialmente la atenci贸n de la obesidad al combinar una p茅rdida de peso efectiva con la preservaci贸n muscular.
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Elevai电� 頃滉淡 韺岉姼雱堨潣 雿办澊韯半ゼ 頇滌毄頃橃棳 IND 頂勲靹胳姢鞕� 鞚错泟 氙戈淡鞐愳劀鞚� 鞛勳儊 鞁滍棙鞚� 臧�靻嶍檾頃橁碃, 須臣鞝侅澑 觳挫 臧愲焿瓿� 攴检湣 氤错樃毳� 瓴绊暕頃橃棳 牍勲 旃橂鞚� 氚╉枼鞚� 鞛爼鞚橅暊 靾� 鞛埖鐢 臧�電レ劚鞚� 臧�歆�瓿� 鞛堨姷雼堧嫟.
Elevai Biosciences, une filiale de Elevai Labs, a annonc茅 un chemin r茅glementaire pour EL-22, une th茅rapie innovante contre l'ob茅sit茅. EL-22, un actif de myostatine de premi猫re classe, vise 脿 pr茅server la masse musculaire tout en r茅duisant la graisse, en abordant la perte musculaire souvent observ茅e avec les traitements bas茅s sur le GLP-1. L'entreprise pr茅voit de soumettre une demande de Investigational New Drug (IND) 脿 la FDA en 2025.
Elevai se pr茅pare 脿 une r茅union pr茅-IND avec la FDA au premier trimestre 2025 pour 茅tablir le chemin de d茅veloppement d'EL-22. Cette r茅union clarifiera les exigences pr茅cliniques suppl茅mentaires et les ajustements dans la chimie, la fabrication et les contr么les avant la soumission de l'IND. EL-22 a montr茅 des am茅liorations physiologiques et fonctionnelles significatives dans les 茅tudes pr茅cliniques et a compl茅t茅 un essai clinique de phase 1 en Cor茅e du Sud, d茅montrant la s茅curit茅 et la tol茅rabilit茅 chez des volontaires sains.
En s'appuyant sur les donn茅es de leur partenaire cor茅en, Elevai vise 脿 acc茅l茅rer le processus IND et les essais cliniques ult茅rieurs aux 脡tats-Unis, red茅finissant potentiellement les soins d'ob茅sit茅 en combinant une perte de poids efficace avec la pr茅servation musculaire.
Elevai Biosciences, eine Tochtergesellschaft von Elevai Labs, hat einen regulatorischen Weg f眉r EL-22, eine bahnbrechende Therapie gegen Adipositas, angek眉ndigt. EL-22, ein erstklassiger Myostatin-Wirkstoff, zielt darauf ab, die Muskelmasse zu erhalten und gleichzeitig das Fett zu reduzieren, um dem Muskelschwund entgegenzuwirken, der h盲ufig 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 f眉r EL-22 festzulegen. In diesem Meeting werden zus盲tzliche pr盲klinische Anforderungen und Anpassungen in Bezug auf Chemie, Herstellung und Kontrolle vor der IND-Einreichung gekl盲rt. EL-22 hat in pr盲klinischen Studien bedeutende physiologische und funktionale Verbesserungen gezeigt und hat eine Phase-1-Studie in S眉dkorea abgeschlossen, die Sicherheit und Vertr盲glichkeit bei gesunden Probanden demonstriert hat.
Durch die Nutzung von Daten ihres koreanischen Partners m枚chte Elevai den IND-Prozess und die anschlie脽enden klinischen Studien in den USA beschleunigen und m枚glicherweise 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 (鈥淚ND鈥�) application with the U.S. Food and Drug Administration (鈥淔DA鈥�) in 2025.
NEWPORT BEACH, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Elevai Labs Inc.听(Nasdaq: ELAB) (鈥淓levai鈥� or the 鈥淐ompany鈥�), a diversified holding company, subsidiary聽Elevai Biosciences Inc. (鈥淓levai Biosciences鈥�), 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.
鈥淩egulatory precedent for myostatin-based therapies in combination with GLP-1 receptor agonists are promising,鈥� said Deniel Mero, Co-founder of Elevai Biosciences. 鈥淟everaging 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鈥檚 potential to redefine obesity care by combining effective weight loss with muscle preservation.鈥�
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聽.
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鈥檚 pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit聽.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are 鈥渇orward-looking statements鈥� within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as 鈥渂elieves,鈥� 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥減otential,鈥� 鈥渨ould鈥� and 鈥渇uture鈥� or similar expressions such as 鈥渓ook forward鈥� are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor聽assurances of future performance. Instead, they are based only on our current beliefs,聽expectations聽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鈥檚 limited operating history and historical losses; Elevai鈥檚 ability to raise additional funding to complete the development and any commercialization of its product candidates; Elevai鈥檚 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鈥檚 ability to obtain, maintain and protect its intellectual property; Elevai鈥檚 dependence on third parties in connection with manufacturing, clinical trials and preclinical studies; and Elevai鈥檚 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鈥檚 filings with the Securities and Exchange Commission (鈥淪EC鈥�), including the 鈥淩isk Factors鈥� section of the Company鈥檚 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鈥檚 web site at聽. 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聽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聽Lactobacillus casei聽Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci.听2022, 23, 9059.听.听
FAQ
What is the regulatory pathway for EL-22 announced by Elevai Biosciences?
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When is Elevai Biosciences planning to file the IND application for EL-22?
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