Northstrive Biosciences Inc. Schedules Pre-IND Meeting with FDA for EL-22, an Obesity Therapy Targeting Fat Loss and Muscle Preservation in Combination with GLP-1
March 10 2025 - 7:00AM
Northstrive Biosciences Inc. (“Northstrive”), a subsidiary of PMGC
Holdings Inc. (NASDAQ: ELAB) (the “Company,” “PMGC,” “we,” or
“our”), announced that it has scheduled a pre-Investigational New
Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration
(“FDA”) for Wednesday, April 23, 2025. Northstrive will have a
Type B pre-IND meeting with the FDA to discuss the path forward for
filing an IND for EL-22 as a combination treatment with GLP-1 for
muscle preservation.
EL-22 is a novel, patent-pending engineered probiotic designed
to express myostatin on its surface, targeting the validated
myostatin pathway to support muscle health. Preclinical studies,
including a 2022 publication 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.
“The scheduled pre-IND meeting is a crucial step in our
development of EL-22 and underscores our commitment to advancing
this potential breakthrough therapy,” said Deniel Mero, Co-founder
of Northstrive Biosciences. “We expect to walk away from the
meeting with a clear path for moving into human trials, targeting
one of obesity’s biggest unmet needs; the preservation of muscle
for patients on GLP-1 therapies.”
Upon FDA feedback and guidance, Northstrive aims to file the
Investigational New Drug application in 2025 and thereafter
initiate clinical trials to evaluate the combination of EL-22 with
GLP-1 receptor agonists for obesity treatment.
About Northstrive Biosciences Inc.
Northstrive Biosciences Inc., a PMGC Holdings Inc. company, is a
biopharmaceutical company focusing on the development and
acquisition of cutting-edge aesthetic medicines. Northstrive’s
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.northstrivebio.com.
About PMGC Holdings Inc.
PMGC Holdings Inc. is a diversified holding company that manages
and grows its portfolio through strategic acquisitions,
investments, and development across various industries. Currently,
our portfolio consists of three wholly owned subsidiaries:
Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital
LLC. We are committed to exploring opportunities in multiple
sectors to maximize growth and value. For more information, please
visit https://www.pmgcholdings.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 made as of the date of this press
release and 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 PMGC Holdings’ filings with the
United States 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@pmgcholdings.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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