Fully funded study to evaluate Wegovy and
Ozempic patients at risk for increased inflammation associated with
sarcopenic muscle deterioration
Collaboration partner to use AI and machine
learning to identify targeted patient pool
Potential entry into high growth GLP-1
market valued at nearly $50 billion in 2024 and projected to
surpass $100 billion by 2029
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the
“Company”), a clinical stage biopharmaceutical company committed to
developing novel oral therapies for autoimmune and inflammatory
conditions, today announced that it has entered into a
collaborative agreement with Renova Health for a planned trial of
its TNF-alpha (TNF-α) inhibitor drug isomyosamine (MYMD-1) as a
treatment for GLP-1-induced sarcopenia and frailty. The fully
funded study is expected to evaluate TNF-α levels in patients
receiving GLP-1 agonist Wegovy or Ozempic who show signals for
increased inflammation associated with sarcopenia.
“The GLP-1 drug class has transformed the pharmaceutical
landscape in recent years as the prevalence of obesity surges to
record numbers. While GLP-1 receptor agonists are highly effective
in treating overweight and obesity, rapid and extensive weight loss
can bring a range of dangerous complications including sarcopenic
loss of muscle mass and bone density,” said Mitchell Glass, M.D.,
President and Chief Medical Officer of TNFA. “Since our lead drug
targets excess pro-inflammatory TNF-alpha, a primary cause of
sarcopenia, we believe it could provide a much-needed solution for
preserving muscle mass in GLP-1-induced weight loss.
“We look forward to collaborating with Renova Health, a leading
innovator supporting superior healthcare outcomes. Together we will
work to identify the optimal patient pool, sample size, dosing
regimen, and other key objectives for a successful open label
trial,” Dr. Glass added.
Studies have shown that up to 40% of the total weight lost by
GLP-1 patients is lean body mass, which includes skeletal muscle
mass.1 If proven effective in preserving lean muscle mass during
GLP-1 weight loss, isomyosamine could become a first-in-class
therapy for a massive population of younger and middle-aged
overweight and obese patients globally.
“Renova Health is excited to partner with TNF Pharmaceuticals,”
said David Jacobs, CEO of Renova Health. “Together, we share a
commitment to putting patients first and exploring innovative ways
to achieve better outcomes at lower costs. This collaboration
reflects our dedication to treating patients as real people, not
just data points.”
Dr. Juliet Daniel, Medical Director of Renova Health, added,
“This partnership combines Renova’s ‘Hyper-Personalized’ patient
engagement expertise with TNFA’s promising research. Together, we
aim to address key challenges in GLP-1 therapies and advance care
for patients affected by inflammation and muscle loss.”
Currently valued at $49.3 billion, GLP-1 agonists are expected
to be the top selling drug class in 2024.2 The GLP-1 agonist market
is projected to reach $105 billion in 2029, growing at an expected
19.2% CAGR from 2023 to 2029.3
According to the CDC, obesity costs the U.S. healthcare system
nearly $173 billion annually.4
TNFA is currently conducting a Phase 2 clinical trial of
isomyosamine as a treatment for aging-related sarcopenia. Based on
statistically significant positive results from the smaller Phase
2a study, the Company plans to launch a Phase 2b study early in the
first quarter of 2025.
About Isomyosamine
Isomyosamine (MYMD-1®) 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
TNFα plays a causative role in the pathogenesis of various
age-related diseases.
About Renova Health
Renova Health partners with large clinic practices, hospital
systems, and accountable care organizations to help deliver better
patient outcomes at a lower cost. The key to Renova Health’s
success is its highly skilled, caring, and passionate Personal
Health Advocates that create and nurture a personal, trusting
relationship with patients that helps to uncover deeper insights
and ultimately leads to superior healthcare outcomes. For more
information, visit www.renovahealth.care
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.
___________________________
1 Drug Discovery and Development, March
2024
2 Research and Markets, GLP-1 Market:
Industry Trends and Global Forecasts to 2035…., August 2024
3 Global Data, March 2024
4 Centers for Disease Control and
Prevention (CDC), About Obesity, January 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 and the timing of the Company’s planned trial of
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/20241219070411/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@tnfpharma.com www.tnfpharma.com
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