Based on successful Phase 2a data, Company
set to initiate Phase 2b sarcopenia study in early 2025; currently
securing centers of excellence to begin enrollment
First oral TNF-α inhibitor, if approved,
would offer potential patient benefit in an approximate $40 billion
TNF inhibitor market
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 significant positive topline
results from a Phase 2a study of its lead drug candidate MYMD-1®
(isomyosamine) was presented at a prestigious international
congress of global experts in sarcopenia and related disorders held
December 6–8, 2024 in Washington, D.C.
“In our view, MYMD-1 could become a consequential therapeutic
solution for patients not served by current TNF-alpha inhibitors,”
said Mitchell Glass, M.D., President and Chief Medical Officer of
TNFA. “With no FDA-approved treatments available to
sarcopenia/frailty patients that target this disease itself, there
is a large unmet medical need for effective therapies. Plus, the
estimated $3 billion sarcopenia treatment market is just a subset
of the broader TNF inhibitor market which was estimated to be $40
billion in 2024.
“Based on the positive results from our MYMD-1 Phase 2a study,
we are set to launch a Phase 2b study in sarcopenia/frailty early
in the first quarter of 2025,” Dr. Glass added.
The presentation, ‘Isomyosamine for the Treatment of Sarcopenia
in Elderly Population,’ describes the results of a double-blind,
placebo-controlled study in patients aged 65 years or older with
chronic inflammation associated with sarcopenia/frailty. Subjects
in the trial who were given once daily oral doses of MYMD-1 showed
significant decreases in several biomarkers attributed to chronic
inflammation, including tumor necrosis factor-alpha (TNF-α)
(P=0.008), Interleukin-6 (IL-6) (P=0.03) and soluble TNF-α receptor
1 (sTNFR1) (P=0.02) at several timepoints throughout the 28 days of
treatment. No serious adverse events were reported.
The global market value for TNF inhibitors was estimated to be
$39.7 billion for 2024. Growing at an expected 3.6% CAGR for the
next five years, the TNF inhibitor market is expected to reach
$47.3 billion by 2029.1
Sarcopenia is the progressive loss of muscle mass and strength
primarily due to aging. 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.2 The sarcopenia
treatment market is estimated to be $3.07 billion in 2024 and is
expected to grow at a CAGR of 4.48% to $4.02 billion by 2029.3
Approximately 10% to 16% of the elderly worldwide suffer from
sarcopenia.4 In addition to the elderly, sarcopenia is estimated to
affect more than 1 in every 10 young adults of most ethnicities.5
With no FDA-approved treatments for sarcopenia itself, as opposed
to its symptoms, the estimated $40+ billion in related
hospitalization costs is a considerable economic burden on the U.S.
healthcare system.6
The 17th International Conference of the Society on Sarcopenia,
Cachexia, & Wasting Disorders joins researchers, clinicians,
academic experts, investigators and industry leaders from around
the world. SCWD is a non-profit scientific organization comprised
of an international and multidisciplinary group of healthcare
professionals primarily active in these fields.
About MYMD-1®
MYMD-1® (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
TNFα plays a causative role in the pathogenesis of various
age-related diseases.
About TNF Pharmaceuticals, Inc.
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD
Pharmaceuticals, Inc.), 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. MYMD-1® 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.
MYMD-1 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.
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. 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.
1 Mordor Intelligence, TNF Inhibitors Market Size (2024 -
2029)
2 Biology, Sarcopenia Is Associated with an Increased Risk of
Postoperative Complications… (2023)
3 Mordor Intelligence, Sarcopenia Treatment Market Size &
Share Analysis - Growth Trends & Forecasts (2024 - 2029)
4 Metabolism journal, Epidemiology of sarcopenia: Prevalence,
risk factors, and consequences (2023)
5 Metabolism journal, Sarcopenia in youth (2023)
6 Journal of Frailty & Aging, Economic Impact of
Hospitalizations in US Adults with Sarcopenia (2019)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241209916402/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@tnfpharma.com www.tnfpharma.com
TNF Pharmaceuticals (NASDAQ:TNFA)
過去 株価チャート
から 11 2024 まで 12 2024
TNF Pharmaceuticals (NASDAQ:TNFA)
過去 株価チャート
から 12 2023 まで 12 2024
