MYMD-1® development to continue through
fully funded mid-stage clinical trials
Clinical study of MYMD-1 in
sarcopenia/frailty met primary endpoints for significantly reducing
chronic inflammatory markers with statistical significance
MYMD-1 shown to inhibit excessive activity
of TNF-alpha to regulate the immuno-metabolic system
Company holds FDA-cleared Phase 2 INDs for
MYMD-1 in two additional chronic inflammatory conditions,
rheumatoid arthritis and Hashimoto’s thyroiditis
TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the
“Company”), a clinical stage biopharmaceutical company committed to
developing novel therapies for age-related diseases, and autoimmune
and inflammatory conditions, today announced that it is preparing
to advance its lead program, MYMD-1®, through fully funded
mid-stage clinical trials. MYMD-1 is a small molecule shown to
block excessive activity of TNF-alpha (TNF-α) in the blood to
regulate the immuno-metabolic system. The next clinical studies of
MYMD-1 will further explore the drug’s efficacy in
sarcopenia/frailty following statistically significant positive
results from an earlier Phase 2 clinical study.
“In our view, MYMD-1, if approved, could be the first orally
administered TNF-alpha inhibitor drug and the first and only
therapy for sarcopenia, a common age-related disorder that causes a
prolonged decline in physical function. The success of our clinical
strategy and regulatory pathway to date supports MYMD-1’s potential
to disrupt the TNF-alpha inhibitor market,” said Mitchell Glass,
M.D., President and Chief Medical Officer of TNF Pharmaceuticals.
“As we prepare for our next fully funded clinical studies in
sarcopenia/frailty, we also have open INDs for Phase 2 trials of
MYMD-1 in two additional chronic inflammatory conditions,
rheumatoid arthritis (RA) and Hashimoto’s thyroiditis, which we
could pursue with the support of non-dilutive domestic and/or
international development partnerships. A partner outside of the
U.S. could potentially help us accelerate the timeline to
commercialization of our lead asset.
“Each of MYMD-1’s indications provide solid measures of Company
value,” Dr. Glass continued. “We are excited about the positive
data we have gathered so far for our lead asset. Our next steps, to
be revealed soon, will extend our reach toward significant and
sustainable value creation, and long-term Company growth.”
MYMD-1 Phase 2 Clinical Development
MYMD-1 targets TNF-alpha (TNF-alpha tumor necrosis factor-alpha,
or TNF-α), a protein in the body that plays a key role in
inflammation and autoimmunity.
Sarcopenia. A small Phase 2 study, completed in 2023,
investigated the efficacy, tolerability and pharmacokinetics of
MYMD-1 in the treatment of participants with chronic inflammation
associated with sarcopenia/frailty. The study met its primary
endpoints for significantly reducing chronic inflammatory markers
with statistically significant results.
- MYMD-1 significantly reduced serum levels of chronic
inflammatory markers and met all primary pharmacokinetic and
secondary safety and tolerability endpoints.
- MYMD-1 demonstrated statistical significance across three
biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6
(P=0.03).
- No treatment-related adverse events (AEs) or serious adverse
events (SAEs) occurred over the course of the study.
Sarcopenia, the aging-related progressive loss of muscle mass
and strength in older people and in a growing population of younger
people, is a condition which leads to greater risk of
hospitalization, disability, and death. 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.1
Rheumatoid arthritis (RA). An Investigational New Drug
(IND) application for a Phase 2 study of MYMD-1 in RA was reviewed
and approved by the FDA in August 2023.
MYMD-1’s small molecule design enables the drug to cross the
blood brain barrier for entry into the central nervous system. In a
preclinical trial, MYMD-1 was shown to significantly reduce
swelling and other clinical arthritis measures compared to the
widely used RA therapy Enbrel® (etanercept).2 Disease severity
(total composite score) was reduced by 47% with MYMD-1 (450
mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg
by subcutaneous injection).
RA is a chronic, systemic inflammatory disorder that causes
chronic inflammation of the joints and affects approximately 1.5
million Americans. RA’s cost to society, including healthcare
costs; loss of employment; costs to employers, government, and
caregivers; and costs associated with a deterioration of quality of
life, is estimated to be over $40 billion annually.3
Hashimoto’s thyroiditis. MYMD holds an FDA-cleared IND
for a Phase 2 pilot study of MYMD-1 for Hashimoto’s thyroiditis, a
condition in which the immune system stops recognizing the thyroid
as part of the body and begins attacking it.
Hashimoto’s thyroiditis is the most common cause of
hypothyroidism in the United States.4 According to an American
Thyroid Association report, approximately 12% of the U.S.
population will develop a thyroid condition during their lifetime
and an approximate amount of 20 million Americans are diagnosed
with some form of thyroid disease during their lifetime.5 The
global thyroid gland disorder market was valued at $2.1 billion in
2017, and is estimated to reach $2.7 billion by 2025 at a CAGR of
3.8% from 2018 to 2025.6
Secondary Drug Platform — Supera-CBD™
TNFA’s secondary drug platform, Supera-CBD™, is a
synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times
more potent CB2 agonist than plant-based CBD.7 Supera-CBD is
targeted for the treatment of epilepsy, pain and
anxiety/depression. Based on an in vitro binding analysis of
Supera-CBD with three types of opioid receptors, the profile
suggests that Supera-CBD could play a role in treating opioid
addiction.
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 Journal of Frailty & Aging, Economic Impact of
Hospitalizations in US Adults with Sarcopenia (2019) 2 ENBREL
ETANERCEPT is a registered trademark of Immunex Corporation 3
https://reporter.nih.gov/project-details/10080141 4 Taylor N Peter
et al. Global epidemiology of hyperthyroidism and hypothyroidism.
Nature: Endocrinology. 2018 May; 14:301-316. 5 American Thyroid
Association. General Information/Press Room. Available in:
https://www.thyroid.org/media-main/press-room/ 6 KUNSEL, Tenzin.
Thyroid Gland Disorder Treatment Market. Allied Market Search,
2018. Available in: <
https://www.alliedmarketresearch.com/thyroid-gland-disorder-treatment-market
> 7 Company reports; study conducted by Eurofins Discovery, a
Eurofins Scientific (EUFI.PA) company
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240821460281/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@tnfpharma.com www.tnfpharma.com
TNF Pharmaceuticals (NASDAQ:TNFA)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
TNF Pharmaceuticals (NASDAQ:TNFA)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024
