Believed to be the only IND application ever
cleared by the FDA for a Phase 2 trial of a patented drug for
delaying aging
Phase 2 trial recruiting begins immediately;
efficacy data expected by the end of the first quarter of 2022
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the
Company”), a clinical stage pharmaceutical company committed to
extending healthy lifespan by delaying aging, announced today that
it has received U.S. Food and Drug Administration clearance of its
Investigational New Drug (IND) application for the Phase 2 trial of
MYMD-1 as a therapy for delaying aging and prolonging healthy
lifespan. Recruitment for the Phase 2 trial will begin immediately,
and efficacy data is expected by the end of first quarter of
2022.
“To our knowledge, ours is the only IND application ever
accepted by the FDA for a Phase 2 trial of a patented drug that
seeks to delay aging. While there are other TNF-alpha, IL-6 and
IL-17 blockers on the market, they are used for other indications;
those drugs are not approved by the FDA for treating aging,
frailty, and sarcopenia (loss of muscle tissue),” explained Chris
Chapman, M.D., President, Director and Chief Medical Officer of
MyMD. “Our treatment designed for delaying aging has a distinctive
drug profile of oral delivery, selectivity, and very low toxicity
as compared with TNF blockers, all of which are delivered by
injection only.
“MYMD-1 is designed to become the first and only FDA-approved
therapeutic solution for delaying aging and prolonging
healthspan—i.e. years of life with minimized chronic disease and
maximized good health,” Dr. Chapman continued. “For multiple health
and safety reasons, we believe orally dosed MYMD-1 is vastly
superior to any of the available TNF inhibitors on the market
today, one of which is the best-selling drug in the world.”
As cleared by the FDA, the primary endpoint of the Phase 2
double-blind, placebo-controlled clinical trial is to achieve a
reduction in the circulating levels of tumor necrosis factor-alpha
(TNF-α), tumor necrosis factor receptor I (TNFRI) and IL-6. TNF-α
and IL-6 are the proteins in the body that cause inflammation and
help activate the process of aging. Chronic inflammation is the
common factor in aging and all aging-related diseases including
frailty, sarcopenia, and autoimmunity. Since TNF-α is the master
regulator of inflammation, MYMD-1’s function as a TNF-α inhibitor
targets one of the root causes of aging, not just the symptoms. The
secondary measures will be the safety, tolerability, and
pharmacokinetics in this population of patients.
The market for treating aging disorders and extending healthy
lifespan is 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.
About MYMD-1
Originally developed for autoimmune diseases, MYMD-1’s primary
purpose is to slow the aging process, prevent sarcopenia (loss of
muscle tissue in aging) and frailty, and extend healthy lifespan.
Because it can cross the blood-brain barrier and gain access to the
central nervous system (CNS), MYMD-1 is also positioned to be a
possible treatment for brain-related disorders. Its mechanism of
action and efficacy in diseases including multiple sclerosis (MS)
and thyroiditis have been studied through collaborations with
several academic institutions. MYMD-1 is also showing promise as a
potential treatment for post-COVID-19 complications and as an
anti-fibrotic and anti-proliferation therapeutic.
MYMD-1 has shown effectiveness in pre-clinical studies in
regulating the immune system by performing as a selective inhibitor
of tumor necrosis factor-alpha (TNF-α), a driver of chronic
inflammation. Unlike other therapies, MYMD-1 has been shown in
these studies to selectively block TNF-α when it becomes
overactivated in autoimmune diseases and cytokine storms, but not
block it from doing its normal job of being a first responder to
any routine type of moderate infection. MYMD-1’s ease of oral
dosing is another 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. In
addition, the drug is not immunosuppressive and has not been shown
to cause the serious side effects common with traditional therapies
that treat inflammation.
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 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 delay aging, increase
longevity, and treat autoimmune diseases and COVID-19- associated
depression. 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.mymd.com.
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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211116005385/en/
MyMD Contact: Robert Schatz (646) 421-9523
rschatz@mymd.com www.mymd.com
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