Key objective of the trial is to reduce levels
of the protein that causes inflammation and activates aging, TNF-α,
in the blood
MYMD-1 is designed to become the first and only
FDA-approved therapeutic solution for delaying aging and prolonging
lifespan
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the
Company”), a clinical stage pharmaceutical company committed to
extending healthy lifespan, today announced that it intends to
initiate dosing for a Phase 2 trial of MYMD-1’s function in
delaying aging early in the fourth quarter of 2021. Interim
efficacy analysis from this study is expected in the first quarter
of 2022.
The primary goal of this Phase 2 double-blind,
placebo-controlled clinical trial is to achieve a reduction in the
levels of tumor necrosis factor-alpha (TNF-α) in the blood. TNF-α
is the protein in the body that causes inflammation and helps
activate the process of aging.
“If MYMD-1 can demonstrate TNF-α reduction in the blood, our
immunometabolic regulator could eventually become the first and
only FDA-approved therapeutic solution for delaying aging and
prolonging lifespan,” stated Chris Chapman, M.D., President,
Director and Chief Medical Officer of MyMD. “MYMD-1 is designed to
address massive markets, giving it the opportunity to transform
major health sectors across the medical landscape.”
“Chronic inflammation is the common factor in aging and all
aging-related diseases including frailty, sarcopenia (loss of
muscle tissue), and autoimmunity. Since TNF-α is the master
regulator of inflammation, MYMD-1’s function as a TNF-α inhibitor
targets the root cause of aging, not just the symptoms,” said Adam
Kaplin, M.D., Ph.D., Chief Scientific Officer. “Positive data from
this important study would significantly advance MYMD-1’s potential
to become a blockbuster drug for inflammation and aging.”
MYMD-1’s ease of oral dosing is a groundbreaking differentiator
compared to currently available TNF-α blockers, all of which
require delivery by injection or infusion. No approved TNF
inhibitor has ever been dosed orally. The second and third key
differentiators are selectivity and low toxicity. Unlike other
therapies, MYMD-1 is designed to selectively block TNF-α when it
becomes overactivated in autoimmune diseases and cytokine storms,
but not to block it from doing its normal job of being a first
responder to any routine type of moderate infection. In addition,
the drug is not immunosuppressive and has not been shown to cause
serious side effects common with traditional therapies that treat
inflammation.
Commenting on the size and scope of the market for delaying
aging, Dr. Chapman added, “There are no FDA-approved drugs for
treating aging disorders and extending healthy lifespan in humans,
a market expected to be at least $600 billion by 20251 according to
a major investment bank. TNF-α blockers are the most prescribed
drugs by revenue, a global market of about $40 billion per year,2
and, according to Nature Aging journal,3 a slowdown in aging that
would increase life expectancy by one year is worth $38 trillion
and by 10 years is worth $367 trillion.”
MYMD-1’s primary purpose is to slow the aging process and extend
human lifespan, but it is also showing promise as a potential
treatment for COVID-19-related complications, and as an
anti-fibrotic and anti-prolific therapeutic. Because it can cross
the blood-brain barrier, MYMD-1 is also positioned to be a possible
treatment for multiple sclerosis and other brain-related
disorders.
In addition to the upcoming Phase 2 aging trial, MyMD previously
announced that it intends to initiate a Phase 2 trial of MYMD-1 as
a therapy for COVID-19-associated depression and cytokine elevation
in the fourth quarter of 2021, with initial trial data expected in
the first quarter of 2022.
About MyMD Pharmaceuticals, Inc. MyMD Pharmaceuticals,
Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company
committed to extending healthy lifespan, is focused on developing
two novel therapeutic platforms that treat the causes of disease
and decline rather than only addressing the symptoms. MYMD-1 is a
drug platform based on a clinical stage small molecule that
regulates the immunometabolic system to control TNF-α, a driver of
chronic inflammation, and other pro-inflammatory cell signaling
cytokines. MYMD-1 is being developed to treat aging and longevity,
autoimmune diseases, and COVID-19- associated depression and
cytokine elevation. The Company’s second drug platform, Supera-CBD,
is being developed to treat chronic pain, addiction and epilepsy.
Based on a novel synthetic derivative of cannabidiol (CBD),
Supera-CBD is being developed to address the rapidly growing CBD
market, which includes both FDA approved drugs and CBD products not
currently regulated as drugs. For more information, visit
www.mymd.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 none of MyMD 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 timing
of, and MyMD’s ability to, obtain and maintain regulatory approvals
for clinical trials of MyMD’s pharmaceutical candidates; the timing
and results of MyMD’s planned clinical trials for its
pharmaceutical candidates; the amount of funds MyMD requires for
its pharmaceutical candidates; increased levels of competition;
changes in political, economic or regulatory conditions generally
and in the markets in which MyMD operates; MyMD’s ability to retain
and attract senior management and other key employees; MyMD’s
ability to quickly and effectively respond to new technological
developments; MyMD’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 MyMD’s
proprietary rights; and the impact of the ongoing COVID-19 pandemic
on MyMD’s results of operations, business plan and the global
economy. A discussion of these and other factors with respect to
MyMD is set forth in the Quarterly Report on Form 10-Q for the
quarterly period ended June 30, 2021, filed by MyMD on August 16,
2021. Forward-looking statements speak only as of the date they are
made and MyMD disclaims any intention or obligation to revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
1
https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html
2 October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs
Market, Acumen Research and Consulting
3 Nature Aging | VOL 1 | July 2021 | p. 616–623
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210913005207/en/
Investor: Robert Schatz (646) 421-9523 rschatz@mymd.com
www.mymd.com Media: media@mymd.com
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