Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Engages Leading Contract Research Organization (CRO) to Support Regulatory Planning Efforts and Pre-IND Meeting with the Food and Drug Administration For EL-22 For The Treatment of Obesity
Elevai Biosciences, a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB), has engaged KCRN Research, Inc. to support its regulatory planning efforts for EL-22, a novel myostatin asset for potential obesity treatment. The company aims to submit an Investigational New Drug (IND) application to the FDA in 2025 and initiate clinical trials in the U.S. to evaluate EL-22 in combination with GLP-1 receptor agonists for obesity treatment.
EL-22 is an engineered probiotic targeting the myostatin pathway, which regulates muscle. It may offer a solution to muscle wasting, a common side effect of popular GLP-1 weight-loss medications. Preclinical results have shown improvements in dystrophic features of mdx mice. The company believes EL-22's oral approach differentiates it from other injectable myostatin strategies being tested for obesity treatment.
Elevai Biosciences, una filiale di Elevai Labs Inc. (NASDAQ: ELAB), ha incaricato KCRN Research, Inc. di supportare i suoi sforzi di pianificazione regolatoria per EL-22, un nuovo asset myostatin per il potenziale trattamento dell'obesità. L'azienda punta a presentare una Richiesta di Indagine su Nuovi Farmaci (IND) alla FDA nel 2025 e ad avviare studi clinici negli USA per valutare EL-22 in combinazione con agonisti del recettore GLP-1 per il trattamento dell'obesità.
EL-22 è un probiotico ingegnerizzato che colpisce la via del myostatin, che regola il muscolo. Potrebbe offrire una soluzione per la perdita di massa muscolare, un effetto collaterale comune dei popolari farmaci per la perdita di peso a base di GLP-1. I risultati preclinici hanno mostrato miglioramenti nelle caratteristiche distrofiche dei topi mdx. L'azienda crede che l'approccio orale di EL-22 lo differenzi da altre strategie iniettabili di myostatin attualmente testate per il trattamento dell'obesità.
Elevai Biosciences, una subsidiaria de Elevai Labs Inc. (NASDAQ: ELAB), ha contratado a KCRN Research, Inc. para apoyar sus esfuerzos de planificación regulatoria para EL-22, un nuevo activo de myostatin para el tratamiento potencial de la obesidad. La empresa tiene como objetivo presentar una Solicitud de Nuevo Medicamento en Investigación (IND) a la FDA en 2025 e iniciar ensayos clínicos en EE. UU. para evaluar EL-22 en combinación con agonistas del receptor GLP-1 para el tratamiento de la obesidad.
EL-22 es un probiótico diseñado que se dirige a la vía del myostatin, que regula el músculo. Podría ofrecer una solución para la pérdida de masa muscular, un efecto secundario común de los medicamentos populares para la pérdida de peso basados en GLP-1. Los resultados preclínicos han mostrado mejoras en las características distrofias de los ratones mdx. La empresa cree que el enfoque oral de EL-22 lo diferencia de otras estrategias inyectables de myostatin que se están probando para el tratamiento de la obesidad.
Elevai Biosciences, Elevai Labs Inc. (NASDAQ: ELAB)의 자회사,는 KCRN Research, Inc.와 협력하여 EL-22에 대한 규제 계획 노력을 지원하고 있습니다. EL-22는 잠재적인 비만 치료를 위한 새로운 미오스타틴 자산입니다. 이 회사는 2025년 FDA에 임상 시험 신청서 (IND)를 제출하고 미국에서 GLP-1 수용체 작용제와 EL-22의 조합을 평가하기 위해 임상 시험을 시작하는 것을 목표로 하고 있습니다.
EL-22는 근육을 조절하는 미오스타틴 경로를 타겟으로 하는 엔지니어링된 프로바이오틱스입니다. 이는 GLP-1 기반의 인기 체중 감소 약물의 일반적인 부작용인 근육 소모 문제에 대한 해결책을 제공할 수 있습니다. 전임상 결과는 mdx 쥐의 근육 위축 특성 개선을 보여주었습니다. 이 회사는 EL-22의 경구 투여 방식이 비만 치료를 위한 다른 주사식 미오스타틴 전략들과의 차별화를 돕는다고 믿고 있습니다.
Elevai Biosciences, une filiale de Elevai Labs Inc. (NASDAQ: ELAB), a engagé KCRN Research, Inc. pour soutenir ses efforts de planification réglementaire concernant EL-22, un nouvel actif myostatine pour un traitement potentiel de l'obésité. L'entreprise prévoit de soumettre une Demande de Médicament Expérimental (IND) à la FDA en 2025 et de lancer des essais cliniques aux États-Unis afin d'évaluer EL-22 en combinaison avec des agonistes des récepteurs GLP-1 pour le traitement de l'obésité.
EL-22 est un probiotique conçu qui cible la voie myostatin, qui régule le muscle. Il pourrait offrir une solution pour la perte de masse musculaire, un effet secondaire courant des médicaments populaires de perte de poids à base de GLP-1. Les résultats précliniques ont montré des améliorations des caractéristiques dystrophiques chez des souris mdx. L'entreprise pense que l'approche orale d'EL-22 le distingue des autres stratégies de myostatin injectables actuellement testées pour le traitement de l'obésité.
Elevai Biosciences, eine Tochtergesellschaft von Elevai Labs Inc. (NASDAQ: ELAB), hat KCRN Research, Inc. beauftragt, ihre regulatorischen Planungsbemühungen für EL-22, ein neuartiges Myostatin-Asset zur potenziellen Behandlung von Fettleibigkeit, zu unterstützen. Das Unternehmen plant, 2025 einen Investigational New Drug (IND)-Antrag bei der FDA einzureichen und klinische Studien in den USA zu initiieren, um EL-22 in Kombination mit GLP-1-Rezeptor-Agonisten zur Behandlung von Fettleibigkeit zu evaluieren.
EL-22 ist ein gentechnisch veränderter Probiotikum, das den Myostatin-Weg anspricht, der den Muskel reguliert. Er könnte eine Lösung für Muskelschwund bieten, eine häufige Nebenwirkung beliebter GLP-1-Abmagerungsmedikamente. In präklinischen Ergebnissen wurden Verbesserungen der dystrophischen Merkmale von mdx-Mäusen gezeigt. Das Unternehmen ist überzeugt, dass der orale Ansatz von EL-22 ihn von anderen injizierbaren Myostatin-Strategien unterscheidet, die derzeit zur Behandlung von Fettleibigkeit getestet werden.
- Engagement of KCRN Research to support regulatory planning for EL-22
- Planned IND submission to FDA in 2025
- Potential solution for muscle wasting side effect of GLP-1 medications
- Preclinical results showed improvements in dystrophic features of mdx mice
- Differentiated oral approach compared to injectable myostatin strategies
- IND submission and clinical trials are still in the future (2025)
- EL-22 is still in early stages of development
Insights
This news represents a significant step forward for Elevai Biosciences in their pursuit of developing EL-22 for obesity treatment. The engagement of KCRN Research as a CRO is a strategic move to navigate the complex regulatory landscape and prepare for FDA interactions. Key points to consider:
- The planned IND submission in 2025 sets a clear timeline for potential clinical trials, which could accelerate the development process.
- EL-22's focus on muscle preservation addresses a critical unmet need in the rapidly growing market for GLP-1 weight-loss medications.
- The oral administration of EL-22 could provide a competitive advantage over injectable myostatin therapies currently in development.
However, investors should note that the road to FDA approval is long and uncertain. While preclinical results are promising, clinical trials will be important in demonstrating EL-22's efficacy and safety in humans. The potential market is substantial, given the popularity of GLP-1 drugs, but success is not guaranteed. This development stage is typically associated with high risk and significant capital requirements for biotech companies.
The collaboration between Elevai Biosciences and KCRN Research is a strategic move in the competitive obesity treatment landscape. Key market implications include:
- Potential for a combination therapy approach, pairing EL-22 with existing GLP-1 drugs, which could create a new market segment.
- Addressing the muscle wasting side effect of GLP-1 medications could significantly enhance patient outcomes and expand the overall market for obesity treatments.
- The oral administration of EL-22 could improve patient compliance and potentially capture a larger market share compared to injectable alternatives.
The obesity treatment market is projected to grow substantially, with GLP-1 drugs leading the charge. If successful, EL-22 could tap into this expanding market. However, investors should be aware that the development timeline extends to at least 2025 and regulatory hurdles remain. The company's ability to secure funding for clinical trials and navigate the competitive landscape will be important factors in realizing EL-22's market potential.
NEWPORT BEACH, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) --
- EL-22 is a novel myostatin asset for the potential treatment of obesity in combination with existing GLP-1 medicines
- The Investigational New Drug application is planned for submission to the U.S. Food and Drug Administration (“FDA”) in 2025
- Muscle wasting is a common side effect of popular GLP-1 weight-loss medications, with no current approved treatments. EL-22 may offer an importation solution by preserving muscle mass while reducing fat mass
Elevai Biosciences Inc. (“Elevai Biosciences”), a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB) (the “Company” or “Elevai”), today announced that it has engaged KCRN Research, Inc., a global contract research organization (CRO), to support the Company’s initial efforts to prepare for an Investigational New Drug (“IND”) application to the FDA for EL-22 in the treatment of obesity and muscle loss preservation.
KCRN specializes in bridging the regulatory gap for Korean-originated assets like EL-22 and preparing early phase drug development projects for the FDA. The Company and CRO partner KCRN are gathering the development work required for the IND submission, including preparing and scheduling a pre-IND meeting with the FDA to determine the path forward for EL-22. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity.
“Myostatin is currently being pursued as a leading approach for muscle preservation in clinical trials with GLP-1 medications,” said Deniel Mero, Co-founder of Elevai Biosciences. “We are excited by this validated pathway and look forward to KCRN’s support in preparing EL-22 for IND submission. We think this collaboration is the first step to preparing EL-22 for eventual clinical trials and KCRN’s familiarity and experience with both the FDA and our asset make them an ideal CRO partner.”
EL-22, an engineered probiotic expressing myostatin on its surface, targets a clinically validated myostatin pathway that plays an important role in regulating muscle. Preclinical results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD)1. The Company believes that EL-22 offers a differentiated, oral approach as compared to other injection myostatin strategies being tested in obesity. It is believed that the mechanism of EL-22 induces mucosal immunity through the body’s own anti-myostatin antibodies and has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass.
“We are delighted in our continued support of Elevai and their myostatin program,” said Hugh Lee, CEO & Founder of KCRN. “We are hopeful that this work may result in a new treatment option for the millions of GLP-1 patients in need of a way to preserve muscle.”
About Elevai Labs, Inc.
Elevai Labs Inc. (NASDAQ: ELAB) 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 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
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