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
October 22 2024 - 8:54AM
- 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 BiosciencesElevai 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
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