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

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