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Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Highlights Past Positive Preclinical Data Showing Potential of EL-32, A Dual Myostatin & Activin-A Blocker, For the Treatment of Obesity

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Elevai Biosciences, a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB), has released encouraging preclinical data from 2022 for EL-32, a dual-action blocker targeting myostatin and activin-A. The study, conducted on aged C57BL/6J mice over 15 weeks, showed statistically significant improvements in grip strength, motor function, and body composition. Elevai believes EL-32 could potentially treat obesity when used alongside GLP-1 receptor agonists by preserving muscle mass while reducing fat mass.

Key findings include:

  • Enhanced grip strength at week 15
  • Improved motor performance with longer rotarod latency durations
  • Optimized body composition demonstrated by DEXA scans

Elevai plans to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application. Full preclinical data is expected to be presented at a future scientific conference.

Elevai Biosciences, una filiale di Elevai Labs Inc. (NASDAQ: ELAB), ha rilasciato dati preclinici incoraggianti del 2022 per EL-32, un bloccante a doppia azione che mira a myostatina e activina-A. Lo studio, condotto su topi C57BL/6J anziani per 15 settimane, ha mostrato miglioramenti statisticamente significativi nella forza di presa, nella funzione motoria e nella composizione corporea. Elevai ritiene che EL-32 potrebbe potenzialmente trattare l'obesità se utilizzato insieme agli agonisti del recettore GLP-1, mantenendo la massa muscolare mentre riduce la massa grassa.

I principali risultati includono:

  • Aumento della forza di presa alla settimana 15
  • Miglioramento delle prestazioni motorie con durate più lunghe di latenza sul rotarod
  • Composizione corporea ottimizzata dimostrata da scansioni DEXA

Elevai prevede di condurre ulteriori studi sugli animali per far avanzare EL-32 verso una domanda di nuova indagine su farmaci (IND). Si prevede che l'intero dato preclinico sarà presentato a una futura conferenza scientifica.

Elevai Biosciences, una subsidiaria de Elevai Labs Inc. (NASDAQ: ELAB), ha lanzado datos preclínicos alentadores de 2022 para EL-32, un bloqueador de doble acción que se dirige a la miostatina y al activina-A. El estudio, realizado en ratones C57BL/6J envejecidos durante 15 semanas, mostró mejoras estadísticamente significativas en la fuerza de agarre, la función motora y la composición corporal. Elevai cree que EL-32 podría tratar potencialmente la obesidad cuando se utiliza junto con agonistas del receptor GLP-1, preservando la masa muscular mientras reduce la masa grasa.

Los hallazgos clave incluyen:

  • Aumento de la fuerza de agarre en la semana 15
  • Mejor rendimiento motor con duraciones de latencia más largas en el rotarod
  • Composición corporal optimizada demostrada por escaneos DEXA

Elevai planea realizar estudios adicionales en animales para avanzar EL-32 hacia una solicitud de nuevo medicamento en investigación (IND). Se espera que los datos preclínicos completos se presenten en una futura conferencia científica.

Elevai Biosciences는 Elevai Labs Inc. (NASDAQ: ELAB)의 자회사로, EL-32에 대한 2022년의 고무적인 전임상 데이터를 발표했습니다. Myostatin과 Activin-A를 표적으로 하는 이중 작용 블로커입니다. 이 연구는 15주 동안 노화된 C57BL/6J 생쥐를 대상으로 실시되었으며, 통계적으로 유의미한 개선이 그립 강도, 운동 기능 및 신체 구성에서 나타났습니다. Elevai는 EL-32가 근육량을 유지하면서 지방량을 감소시키는 경우에 GLP-1 수용체 작용제와 함께 사용될 때 비만을 치료할 수 있다고 믿고 있습니다.

주요 발견 사항은 다음과 같습니다:

  • 15주차에 그립 강도 향상
  • 로타로드에서 더 긴 지연 시간으로 운동 성능 향상
  • DEXA 스캔으로 입증된 최적화된 신체 구성

Elevai는 EL-32를 임상 시험 신약(IND) 신청으로 발전시키기 위해 추가 동물 연구를 수행할 계획입니다. 전체 전임상 데이터는 향후 과학 회의에서 발표될 예정입니다.

Elevai Biosciences, une filiale de Elevai Labs Inc. (NASDAQ: ELAB), a publié des données précliniques encourageantes de 2022 pour EL-32, un bloqueur à double action ciblant la myostatine et l'activine-A. L'étude, réalisée sur des souris C57BL/6J âgées pendant 15 semaines, a montré des améliorations statistiquement significatives de la force de préhension, de la fonction motrice et de la composition corporelle. Elevai pense que EL-32 pourrait potentiellement traiter l'obésité lorsqu'il est utilisé avec des agonistes des récepteurs GLP-1 en préservant la masse musculaire tout en réduisant la masse grasse.

Les principales conclusions comprennent :

  • Force de préhension améliorée à la semaine 15
  • Performance motrice améliorée avec des durées de latence plus longues sur le rotarod
  • Composition corporelle optimisée démontrée par des scans DEXA

Elevai prévoit de réaliser d'autres études sur les animaux pour faire progresser EL-32 vers une demande de nouveau médicament d'investigation (IND). L'ensemble des données précliniques devrait être présenté lors d'une future conférence scientifique.

Elevai Biosciences, eine Tochtergesellschaft von Elevai Labs Inc. (NASDAQ: ELAB), hat ermutigende präklinische Daten aus dem Jahr 2022 für EL-32 veröffentlicht, einen dualen Blocker, der auf Myostatin und Activin-A abzielt. Die Studie, die über einen Zeitraum von 15 Wochen an älteren C57BL/6J-Mäusen durchgeführt wurde, zeigte statistisch signifikante Verbesserungen in der Griffstärke, der motorischen Funktion und der Körperzusammensetzung. Elevai glaubt, dass EL-32 in Kombination mit GLP-1-Rezeptoragonisten potenziell zur Behandlung von Fettleibigkeit beitragen könnte, indem es die Muskelmasse erhält und gleichzeitig die Fettmasse reduziert.

Wichtige Ergebnisse umfassen:

  • Verbesserte Griffstärke in Woche 15
  • Verbesserte motorische Leistung mit längeren Latenzzeiten auf dem Rotarod
  • Optimierte Körperzusammensetzung, die durch DEXA-Scans nachgewiesen wurde

Elevai plant zusätzliche Tierversuche, um EL-32 weiter in Richtung eines Antrags auf einen neuen Prüfmedikament (IND) zu bringen. Vollständige präklinische Daten werden voraussichtlich auf einer zukünftigen wissenschaftlichen Konferenz präsentiert.

Positive
  • Preclinical results show statistically significant improvements in grip strength, motor function, and body composition
  • EL-32 demonstrates potential to treat obesity while preserving muscle mass
  • Company plans to advance EL-32 towards an Investigational New Drug (IND) application
Negative
  • Additional animal studies required before advancing to IND application
  • Full preclinical data not yet publicly available

Insights

The preclinical data for EL-32 shows promise in addressing a significant limitation of current obesity treatments. By targeting both myostatin and activin-A, EL-32 aims to preserve muscle mass while reducing fat, potentially complementing GLP-1 receptor agonists like Ozempic and Mounjaro. The statistically significant improvements in grip strength, motor function and body composition in aged mice are encouraging indicators of EL-32's efficacy.

However, it's important to note that these are early-stage results from 2022 and the path to human trials is still long. The company's plan to conduct additional animal studies before filing an IND application suggests that clinical trials are not imminent. Investors should be aware that drug development is a high-risk, long-term process with many potential hurdles between preclinical success and market approval.

The potential market for a muscle-preserving obesity treatment is substantial, given the rapid growth of GLP-1 agonists. If EL-32 can successfully address the muscle loss associated with these drugs, it could capture a significant share of the expanding obesity treatment market. However, competition in this space is intense and other companies may be pursuing similar approaches.

From a financial perspective, this news represents a potential long-term value driver for Elevai Labs Inc. (ELAB), but with significant uncertainties. The obesity treatment market is projected to reach $54 billion by 2030, presenting a massive opportunity if EL-32 succeeds. However, investors should consider several factors:

  • R&D Costs: Developing EL-32 will require substantial investment in further preclinical and clinical trials.
  • Timeline: The drug development process typically takes 7-10 years from preclinical stages to market approval.
  • Regulatory Risks: FDA approval is never guaranteed, even with promising early data.
  • Competition: Large pharma companies are actively developing similar treatments.

With a market cap of $2.3 million, ELAB is a microcap stock, which inherently carries higher risk. The company's ability to fund the development of EL-32 through to commercialization will be crucial. Investors should closely monitor the company's cash position, burn rate and any potential partnerships or licensing deals that could provide additional funding or validation of the technology.

  • Preclinical results of EL-32 demonstrated statistically significant increases in grip strength, motor function and body composition in aged C57BL/6J mouse model.
  • Elevai believes that EL-32 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.
  • Elevai plans to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application.

NEWPORT BEACH, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Elevai Biosciences Inc. (“Elevai Biosciences”), a subsidiary of Elevai Labs Inc. (NASDAQ: ELAB) (“Elevai” or the “Company”), today released encouraging past preclinical data from 2022 for EL-32, a pioneering dual-action blocker targeting myostatin and activin-A. Preclinical results generated from our licensing partner in a 2022 study indicated that EL-32 may offer a breakthrough approach to obesity treatment by simultaneously preserving muscle mass and reducing fat mass when used alongside popular weight loss therapies such as GLP-1 receptor agonists.

EL-32, an engineered probiotic expressing dual myostatin & activin-A, focuses on two clinically validated targets that play an important role in regulating muscle. During 15-week preclinical studies on aged C57BL/6J mice, EL-32 administration resulted in statistically significant improvements across key measures of physical muscular function and body composition. Highlights from the results of these studies include:

  • Enhanced grip strength, with notable, statistically significant increases observed at week 15.
  • Improved motor performance, evidenced by longer, statistically significant rotarod latency durations.
  • Optimized body composition, demonstrated by DEXA scans.

“Popular GLP-1 medications like Ozempic and Mounjaro are faced with associated loss of muscle,” said Deniel Mero, Co-founder of Elevai Biosciences. Mero stated, “Myostatin and activin-A are two validated targets that have demonstrated potential in muscle mass, strength building, and are also being tested in clinical trials with GLP-1 medications. These validated pathways, literature and the preclinical data generated to date, gives us reasons to believe that EL-32 has the potential to treat obesity while preserving muscle.”

Based on the preclinical data from our licensing partner, Elevai believes that EL-32 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application. Full preclinical data is expected to be shared at a future scientific conference.

About Elevai Labs, Inc.
Elevai 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, a subsidiary of Elevai, is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines. Elevai Biosciences’ lead asset, EL-22, is leveraging a first-in-class 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 U.S. 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


FAQ

What is EL-32 and how does it work?

EL-32 is an engineered probiotic that acts as a dual-action blocker targeting myostatin and activin-A. It aims to preserve muscle mass while reducing fat mass, potentially offering a new approach to obesity treatment when used alongside GLP-1 receptor agonists.

What were the key findings of the preclinical study for EL-32 (ELAB)?

The 15-week preclinical study on aged C57BL/6J mice showed statistically significant improvements in grip strength, motor performance (longer rotarod latency durations), and optimized body composition as demonstrated by DEXA scans.

What are Elevai's next steps for EL-32 development (ELAB)?

Elevai plans to conduct additional animal studies to advance EL-32 towards an Investigational New Drug (IND) application. The company also intends to present full preclinical data at a future scientific conference.

How does EL-32 potentially differ from current obesity treatments like Ozempic (ELAB)?

Unlike GLP-1 medications such as Ozempic, which may cause muscle loss, EL-32 aims to preserve muscle mass while decreasing fat mass. This dual action could potentially offer a more balanced approach to obesity treatment.

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