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Elevai Biosciences, a Subsidiary of Elevai Labs Inc., Expands Patent Portfolio with Two New Filings for EL-22 in Muscle Loss Treatment for Obese Patients, Including GLP-1 Receptor Agonist Combinations

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Elevai Labs, Inc. (NASDAQ: ELAB) has announced the filing of two new patent applications for its lead candidate, EL-22, targeting muscle loss treatment in obese patients. These applications cover EL-22 as a monotherapy and in combination with GLP-1 receptor agonists. EL-22, an engineered probiotic expressing myostatin, aims to preserve muscle mass while reducing fat mass during obesity treatment.

The company has completed a Phase 1 clinical trial in South Korea, demonstrating EL-22's safety and tolerability. Elevai plans to assess its efficacy in combination with leading weight-loss therapies to address muscle wasting, a common side effect of GLP-1 medications. With these new filings, Elevai Biosciences' patent portfolio now includes 4 patent applications and 5 issued patents, providing protection in key markets such as the USA, Japan, China, and Korea.

Elevai Labs, Inc. (NASDAQ: ELAB) ha annunciato la presentazione di due nuove domande di brevetto per il suo candidato principale, EL-22, mirato al trattamento della perdita muscolare nei pazienti obesi. Queste domande coprono EL-22 sia come monoterapia che in combinazione con agonisti del recettore GLP-1. EL-22, un probiotico ingegnerizzato che esprime la mielistatina, ha l'obiettivo di preservare la massa muscolare riducendo al contempo la massa grassa durante il trattamento dell'obesità.

L'azienda ha completato uno studio clinico di Fase 1 in Corea del Sud, dimostrando la sicurezza e la tollerabilità di EL-22. Elevai prevede di valutarne l'efficacia in combinazione con le principali terapie per la perdita di peso per affrontare la perdita muscolare, un effetto collaterale comune dei farmaci GLP-1. Con queste nuove presentazioni, il portafoglio brevetti di Elevai Biosciences include ora 4 domande di brevetto e 5 brevetti concessi, fornendo protezione in mercati chiave come USA, Giappone, Cina e Corea.

Elevai Labs, Inc. (NASDAQ: ELAB) ha anunciado la presentación de dos nuevas solicitudes de patente para su candidato principal, EL-22, dirigido al tratamiento de la pérdida muscular en pacientes obesos. Estas solicitudes cubren EL-22 tanto como monoterapia como en combinación con agonistas del receptor GLP-1. EL-22, un probiótico modificado que expresa la miostatina, tiene como objetivo preservar la masa muscular mientras reduce la masa grasa durante el tratamiento de la obesidad.

La empresa ha completado un ensayo clínico de Fase 1 en Corea del Sur, demostrando la seguridad y tolerabilidad de EL-22. Elevai planea evaluar su eficacia en combinación con las terapias principales para la pérdida de peso para abordar la pérdida muscular, un efecto secundario común de los medicamentos GLP-1. Con estas nuevas presentaciones, el portafolio de patentes de Elevai Biosciences ahora incluye 4 solicitudes de patente y 5 patentes otorgadas, proporcionando protección en mercados clave como EE. UU., Japón, China y Corea.

Elevai Labs, Inc. (NASDAQ: ELAB)는 비만 환자의 근육 손실을 치료하기 위해 EL-22라는 주요 후보 물질에 대한 두 가지 새로운 특허 출원을 발표했습니다. 이 출원은 EL-22를 단독 요법 및 GLP-1 수용체 작용제와의 조합으로 다룹니다. EL-22는 미오스타틴을 표현하는 엔지니어링 프로바이오틱스로, 비만 치료 중 지방량을 줄이면서 근육량을 보존하는 것을 목표로 합니다.

회사는 한국에서 1상 임상 시험을 완료하여 EL-22의 안전성과 내약성을 입증했습니다. Elevai는 근육 소모를 해결하기 위해 주요 체중 감소 치료법과의 조합에서 그 효능을 평가할 계획입니다. 이러한 새로운 출원으로 Elevai Biosciences의 특허 포트폴리오는 이제 4개의 특허 출원과 5개의 부여된 특허를 포함하고 있으며, 미국, 일본, 중국 및 한국과 같은 주요 시장에서 보호를 제공합니다.

Elevai Labs, Inc. (NASDAQ: ELAB) a annoncé le dépôt de deux nouvelles demandes de brevet pour son candidat principal, EL-22, ciblant le traitement de la perte musculaire chez les patients obèses. Ces demandes couvrent EL-22 en tant que monothérapie et en association avec des agonistes du récepteur GLP-1. EL-22, un probiotique modifié exprimant la myostatine, vise à préserver la masse musculaire tout en réduisant la masse grasse durant le traitement de l'obésité.

L'entreprise a terminé un essai clinique de Phase 1 en Corée du Sud, démontrant la sécurité et la tolérance de l'EL-22. Elevai envisage d'évaluer son efficacité en association avec les principales thérapies de perte de poids pour traiter la dégradation musculaire, un effet secondaire courant des médicaments GLP-1. Avec ces nouveaux dépôts, le portefeuille de brevets d'Elevai Biosciences comprend désormais 4 demandes de brevet et 5 brevets délivrés, offrant une protection sur des marchés clés tels que les États-Unis, le Japon, la Chine et la Corée.

Elevai Labs, Inc. (NASDAQ: ELAB) hat die Einreichung von zwei neuen Patentanmeldungen für seinen Hauptkandidaten, EL-22, angekündigt, der auf die Behandlung von Muskelverlust bei fettleibigen Patienten abzielt. Diese Anmeldungen beziehen sich auf EL-22 sowohl als Monotherapie als auch in Kombination mit GLP-1-Rezeptor-Agonisten. EL-22, ein gentechnisch veränderter Probiotikum, das Myostatin exprimiert, zielt darauf ab, die Muskelmasse zu erhalten und gleichzeitig die Fettmasse während der Behandlung von Fettleibigkeit zu reduzieren.

Das Unternehmen hat eine Phase-1-Studie in Südkorea abgeschlossen, die die Sicherheit und Verträglichkeit von EL-22 zeigt. Elevai plant, die Wirksamkeit in Kombination mit führenden Gewichtsreduktionsbehandlungen zu bewerten, um Muskelabbau, eine häufige Nebenwirkung von GLP-1-Medikamenten, anzugehen. Mit diesen neuen Anmeldungen umfasst das Patentportfolio von Elevai Biosciences jetzt 4 Patentanmeldungen und 5 erteilte Patente, die in wichtigen Märkten wie den USA, Japan, China und Korea Schutz bieten.

Positive
  • Filed two new patent applications for EL-22, expanding intellectual property protection
  • Completed Phase 1 clinical trial for EL-22, demonstrating safety and tolerability
  • Potential to address muscle wasting side effect of popular GLP-1 weight-loss medications
  • Patent portfolio now includes 4 applications and 5 issued patents in key markets
Negative
  • EL-22 efficacy in combination with weight-loss therapies yet to be assessed
  • No data on EL-22's effectiveness in treating muscle loss in obese patients

Insights

Elevai Biosciences' patent filings for EL-22 represent a significant advancement in obesity treatment. The company is targeting a important unmet need in the rapidly growing GLP-1 market by addressing muscle loss, a common side effect of these popular weight loss drugs.

Key points:

  • EL-22 is designed to preserve muscle mass while reducing fat, potentially complementing GLP-1 therapies
  • Successful completion of Phase 1 trials demonstrates safety and tolerability
  • The patent applications cover both monotherapy and combination therapy with GLP-1 agonists
  • Elevai's IP portfolio now includes 4 patent applications and 5 issued patents across major markets

This strategic move positions Elevai to potentially capture a significant portion of the obesity treatment market, estimated to reach $54 billion by 2030. The combination therapy approach could lead to partnerships with major pharmaceutical companies already in the GLP-1 space, opening up substantial revenue opportunities.

Elevai's patent filings for EL-22 could significantly impact its market position and financial outlook:

  • Expanded IP portfolio strengthens the company's competitive advantage and potential for licensing deals
  • Addressing muscle loss in obesity treatment opens up a large, untapped market segment
  • Potential for combination therapy with GLP-1 drugs like Ozempic and Wegovy could lead to strategic partnerships and revenue-sharing agreements
  • Successful development could drive substantial revenue growth, given the size of the obesity market

However, investors should note that drug development is a long and costly process with no guaranteed success. The company's current market cap of $2.3 million suggests significant upside potential if EL-22 proves successful, but also implies high risk. Future capital raises may be necessary to fund clinical trials, potentially diluting existing shareholders.

  • Filed two patent applications for lead candidate EL-22, covering muscle loss in obese patients as a monotherapy and in combination with GLP-1 receptor agonists
  • Elevai Biosciences patent portfolio now includes 4 patent applications and 5 issued patents that provide adequate protection in focus markets

NEWPORT BEACH, Calif., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Elevai Labs, Inc. (NASDAQ: ELAB) ("Elevai" or the "Company"), a leader in medical aesthetics, today announced the filing of two novel patent applications for its lead candidate, EL-22, aimed at treating muscle loss in obese patients. These patent applications cover both standalone and combination therapies using EL-22 alongside GLP-1 receptor agonists, marking a significant advancement in obesity treatment.

The newly filed patent applications support the development of EL-22, an engineered probiotic expressing myostatin, designed to revolutionize obesity care by preserving muscle mass while reducing fat mass. EL-22 has successfully completed a Phase 1 clinical trial in South Korea, demonstrating safety and tolerability in healthy volunteers. Elevai now plans to assess the efficacy of EL-22 in combination with leading weight-loss therapies to address muscle wasting—a common side effect of GLP-1 medications—while promoting fat loss.

“While GLP-1 medications such as Ozempic®, Wegovy®, and Mounjaro® dominate the obesity market, a critical gap remains in preserving lean muscle mass during weight loss,” said Deniel Mero, Co-Founder of Elevai Biosciences. “Muscle mass is vital for metabolism, strength, and overall mobility, and our patented EL-22 technology aims to address this unmet need with a first-in-class approach leveraging myostatin inhibition and oral delivery.”

The first patent application, titled “Fusion Protein of MYO-2 for Use in Treating Muscle Loss in Obese Patients” (Patent Application Serial No. 18/895,501), focuses on EL-22 as a monotherapy for treating muscle loss in obese patients. The second patent application, “Combination Therapy of a Fusion Protein of MYO-2 with a GLP-1 Receptor Agonist for Treating Muscle Loss in Obese Patients” (Patent Application Serial No. 18/895,519), covers the use of EL-22 in combination with GLP-1 receptor agonists, enhancing the benefits of current weight-loss drugs by preserving muscle mass.

These patent applications strengthen Elevai's intellectual property portfolio as the Company advances its mission to transform the standard of care for obesity treatment, with the potential to offer a differentiated therapy that preserves muscle loss, a critical component for patient health and quality of life. Elevai Biosciences’ patent portfolio now includes 4 patent applications and 5 issued patents that provide adequate protection in focus markets, including the USA, Japan, China and Korea.

Licensed Product / NationPatent Application Serial No.Title:
EL-32 USA18/627,462Pharmaceutical composition for alleviation, treatment, and prevention of sarcopenia containing microorganism transformed with cell surface display vector operably linked with gene encoding myostatin and activin A proteins as active ingredient
EL-32 Korea10-2022-0136606A pharmaceutical composition for alleviation, treatment and prevention of sarcopenia containing a microorganism transformed with a vector expressing myostatin and activin A on the cell surface as an active ingredient
EL-22 USA18/895,501Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients
EL-22 USA18/895,519Combination Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients
   
Patent No.Registration No.Title:
EL-22 Korea10-0857861-0000Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Thereof
EL-22 Korea10-0872042-0000Cell Surface Expression Vector of Myostatin and Microorganisms Transformed Thereby
EL-22 USA8470551Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Thereof
EL-22 Japan5634867Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Thereof
EL-22 ChinaZL200780101116.2Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Thereof
   

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 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 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 the purpose of Elevai Labs' (ELAB) new patent applications for EL-22?

The new patent applications are for treating muscle loss in obese patients, covering EL-22 as a monotherapy and in combination with GLP-1 receptor agonists.

Has Elevai Labs (ELAB) conducted any clinical trials for EL-22?

Yes, Elevai Labs has completed a Phase 1 clinical trial for EL-22 in South Korea, demonstrating its safety and tolerability in healthy volunteers.

How many patents and applications does Elevai Biosciences (ELAB) now have in its portfolio?

Elevai Biosciences' patent portfolio now includes 4 patent applications and 5 issued patents, providing protection in key markets such as the USA, Japan, China, and Korea.

What is the potential advantage of Elevai Labs' (ELAB) EL-22 over current GLP-1 weight-loss medications?

EL-22 aims to preserve muscle mass while reducing fat mass, potentially addressing the muscle wasting side effect common in GLP-1 medications used for weight loss.

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