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

Rhea-AI Summary

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.

Positive

• 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.

Negative

• IND application not yet filed, pending pre-IND meeting outcomes.
• Potential delays if additional preclinical requirements are identified.

• 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?

Elevai Biosciences announced plans to file an IND application with the FDA for EL-22 in 2025, with a pre-IND meeting scheduled for Q1 2025.

What is EL-22 and what does it aim to treat?

EL-22 is a first-in-class myostatin asset developed to treat obesity by preserving muscle mass while reducing fat.

When is Elevai Biosciences planning to file the IND application for EL-22?

Elevai Biosciences plans to file the IND application for EL-22 in 2025.

What were the results of the Phase 1 clinical trial for EL-22?

The Phase 1 clinical trial in South Korea showed that EL-22 was generally well tolerated and safe in healthy volunteers.

What is the significance of the pre-IND meeting with the FDA for EL-22?

The pre-IND meeting will establish the development pathway for EL-22, clarifying additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission.