Fully funded multi-center study initiated at
University of Florida to further explore efficacy of isomyosamine
for preventing progressive muscle loss and frailty
Study builds on positive results achieved in
earlier Phase 2a trial
TNF-alpha inhibitor market estimated at $40+
billion with no FDA-approved oral treatments
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the
“Company”), a clinical stage biopharmaceutical company committed to
developing novel therapies for autoimmune and inflammatory
conditions, today announced the initiation of a fully funded Phase
2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug
candidate isomyosamine as a treatment for chronic inflammation
associated with muscle loss (frailty or sarcopenia) in patients who
have undergone hip or femur fracture repair surgery.
“The initiation of our Phase 2b isomyosamine trial marks an
important milestone in our mission to develop a novel science for
immuno-metabolic regulation and increased longevity,” said Mitchell
Glass, M.D., President and Chief Medical Officer of TNF. “A deeper
exploration of isomyosamine’s efficacy will be studied in patients
with acute post-surgical inflammation and complications from hip or
femur fractures. In addition to further functional decline, these
patients face a higher likelihood of complications that can
compromise or delay recovery and are associated with higher
healthcare costs.”
According to Jay Magaziner, Ph.D., Director of the Center for
Research on Aging at the University of Maryland and founder of the
Baltimore Hip Studies project that evaluates outcomes after hip
fractures in older patients, “After hip fracture, older patients
can precipitously lose bone, muscle, and function, which is
associated with a systemic inflammatory response. If we can block
this inflammatory response, we have a chance to reduce the amount
of muscle loss and the associated functional loss, leading to
better outcomes in hip fracture among older persons.”
The upcoming Phase 2b trial to be initiated at the University of
Florida is a randomized, placebo-controlled, double-blind study
evaluating the efficacy and safety of isomyosamine in reducing
inflammation in patients with sarcopenia undergoing fracture
repair. Sixty patients will be treated with isomyosamine or placebo
for up to 90 days after surgery. The study will measure the extent
and time course of recovery to evaluate functional improvement,
comparing active dosing to placebo.
The site’s principal investigator is Porter Young, M.D., an
assistant professor of orthopaedic surgery and rehabilitation at
the University of Florida. His research centers on acetabulum
fractures, pelvis fractures, periarticular fractures and management
of polytrauma patients.
Isomyosamine is an oral, next-generation TNF-α inhibitor with
the potential to transform the way TNF-α based diseases are treated
due to its selectivity and ability to cross the blood brain
barrier. Its ease of oral dosing is a significant differentiator
compared to currently available TNF-α inhibitors, all of which
require delivery by injection or infusion. Isomyosamine has also
been shown to selectively block TNF-α action where it is
overactivated without preventing it from doing its normal job of
responding to routine infection. In addition, in early clinical
studies it has not been associated with serious side effects known
to occur with traditional immunosuppressive therapies that treat
inflammation.
Burden of Sarcopenia
Sarcopenia (ICD-10-CM code M62.84) affects approximately 10% to
16% of the elderly worldwide.1 It is also estimated to affect more
than 1 in every 10 young adults of most ethnicities.2 Based on
conservative calculations, at least 50 million people were affected
by sarcopenia in 2018, and the disease is projected to affect over
200 million over the next four decades due to the growing elderly
population.3
The sarcopenia treatment market is estimated to be $3.07 billion
in 2024 and is expected to grow at a compound annual growth rate
(CAGR) of 4.5% to $4.0 billion by 2029.4 With no FDA-approved
treatments for sarcopenia, the estimated $40+ billion in related
hospitalization costs is a considerable economic burden on the U.S.
healthcare system.5
The global market value for TNF inhibitor drugs was estimated to
be $39.7 billion in 2024. Growing at an expected CAGR of 3.6% for
the next five years, the TNF inhibitor market is expected to reach
$47.3 billion by 2029.6
About Isomyosamine
Isomyosamine is a novel plant alkaloid small molecule shown to
regulate the immuno-metabolic system through the modulation of
numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an
immune cell signaling protein and inflammatory cytokine responsible
for inducing and maintaining the inflammatory process. TNF-α is
located upstream of a cascade of molecular signals that induces
inflammation and helps activate the process of aging. Many in vivo
and in vitro studies have shown that TNF-α plays a causative role
in the pathogenesis of various age-related diseases.
________________
1 Metabolism journal, Epidemiology of sarcopenia: Prevalence,
risk factors, and consequences (2023) 2 Metabolism journal,
Sarcopenia in youth (2023) 3 Biology, Sarcopenia Is Associated with
an Increased Risk of Postoperative Complications… (2023) 4 Mordor
Intelligence, Sarcopenia Treatment Market Size & Share Analysis
- Growth Trends & Forecasts (2024 - 2029) 5 Journal of Frailty
& Aging, Economic Impact of Hospitalizations in US Adults with
Sarcopenia (2019) 6 Mordor Intelligence, TNF Inhibitors Market Size
(2024 - 2029)
About TNF Pharmaceuticals, Inc.
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage
pharmaceutical company committed to extending healthy lifespan, is
focused on developing two novel therapeutic platforms that treat
the causes of disease rather than only addressing the symptoms.
Isomyosamine is a drug platform based on a clinical stage small
molecule that regulates the immune system to control TNF-α, which
drives chronic inflammation and other pro-inflammatory cell
signaling cytokines. Isomyosamine is being developed to treat
diseases and disorders marked by acute or chronic inflammation. The
Company’s second drug platform, Supera-CBD, is being developed to
treat chronic pain, addiction and epilepsy. Supera-CBD is a novel
synthetic derivative of cannabidiol (CBD) and is being developed to
address and improve upon the rapidly growing CBD market, which
includes both FDA approved drugs and CBD products not currently
regulated as drugs. For more information, visit
www.tnfpharma.com.
About the University of Florida
The University of Florida is a premier academic institution that
has repeatedly ranked as one of the top five public universities in
the country, according to U.S. News & World Report. With
campuses in Gainesville and Jacksonville, UF’s health sciences
centers and colleges attract the brightest students, scholars,
scientists and health care providers from across the country and
abroad.
UF faculty conducted a record $1.26 billion in research in
fiscal year 2024.
Cautionary Statement Regarding Forward-Looking
Statements
This press release may contain forward-looking statements. These
forward-looking statements involve known and unknown risks,
uncertainties and other factors which may cause actual results,
performance or achievements to be materially different from any
expected future results, performance, or achievements.
Forward-looking statements speak only as of the date they are made
and neither the Company nor its affiliates assume any duty to
update forward-looking statements. Words such as “anticipate,”
“believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,”
“would’’ and other similar expressions are intended to identify
these forward-looking statements. Examples of such statements
include, but are not limited to, statements regarding the Company’s
ability to launch, the success and timing of, the Company’s planned
trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced
sarcopenia and frailty. Important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements include, without limitation: the
Company’s ability to maintain compliance with the Nasdaq Stock
Market’s listing standards; the timing of, and the Company’s
ability to, obtain and maintain regulatory approvals for clinical
trials of the Company’s pharmaceutical candidates; the timing and
results of the Company’s planned clinical trials for its
pharmaceutical candidates; the amount of funds the Company requires
for its pharmaceutical candidates; increased levels of competition;
changes in political, economic or regulatory conditions generally
and in the markets in which the Company operates; the Company’s
ability to retain and attract senior management and other key
employees; the Company’s ability to quickly and effectively respond
to new technological developments; and the Company’s ability to
protect its trade secrets or other proprietary rights, operate
without infringing upon the proprietary rights of others and
prevent others from infringing on the Company’s proprietary rights.
A discussion of these and other factors with respect to the Company
is set forth in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2023, filed by the Company on April 1,
2024, and subsequent reports that the Company files with the
Securities and Exchange Commission. Forward-looking statements
speak only as of the date they are made, and the Company disclaims
any intention or obligation to revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20250225405912/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@tnfpharma.com www.tnfpharma.com
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