MyMD Pharmaceuticals’ Lead Compound MYMD-1 Shown to Suppress a Major Cause of Death in COVID-19 in Human Cell Study
August 05 2021 - 10:30AM
Business Wire
- MYMD-1 human cell research study demonstrates drug’s ability to
target immune dysfunction and cytokine storm that leads to death
from COVID-19
- Phase 2 trial of MYMD-1 as a therapy for COVID-19-associated
depression and cytokine elevation expected to begin by fourth
quarter 2021; initial trial data expected in first quarter
2022
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the
Company”), a clinical stage pharmaceutical company committed to
extending healthy lifespan by focusing on developing two
therapeutic platforms, today announced that a human cell research
study of lead clinical compound MYMD-1 found the drug to be
effective in suppressing the cytokine storm, a major cause of
severity and death in COVID-19 patients.
Accumulating evidence suggests that an increased level of
inflammatory mediators, including cytokines, are associated with
the severity of COVID-19.1 Cytokine storm causes an overreaction of
the immune system that can cause the body to attack its own tissues
and organs, leading to a high proportion of deaths from
COVID-19.
“MYMD-1’s potential ability to stop one of the leading causes of
death in COVID-19 is among the most exciting developments in our
research to date,” said Chris Chapman, M.D., President, Director
and Chief Medical Officer of MyMD. “MYMD-1 regulates the
immuno-metabolic system by modulating numerous pro-inflammatory
cell signaling molecules called cytokines. The primary cytokine
that MYMD-1 inhibits is TNF-α (tumor necrosis factor alpha). MYMD-1
has been shown in laboratory tests of human cells to block TNF-α
production – and the cytokine storm of COVID-19 that it produces –
which have been implicated in causing injury and death from the
coronavirus disease.
“MYMD-1 was first developed for the treatment of autoimmune and
age-related diseases including extending human lifespan, but its
mechanism of action offers potential therapeutic benefit for
COVID-19 conditions,” Dr. Chapman continued.
“Along with our focus on extending healthy lifespan, treatment
for COVID-19-related complications is now a cornerstone of our
clinical development plan for MYMD-1.”
COVID-19 Associated Depression
MYMD-1 may also be effective as a therapy for
COVID-19-associated depression. MyMD is collaborating with a major
medical school for a Phase 2 clinical trial to investigate the
effectiveness of MYMD-1 to treat immune mediated depression and
cytokine elevation in patients affected with COVID-19. As a
COVID-19-related therapy, MYMD-1 has the potential to move rapidly
toward FDA approval through a special emergency program created to
move new treatments into the clinic as quickly as possible.
According to MyMD Chief Scientific Officer Adam Kaplin, M.D.,
Ph.D., “The importance of our upcoming Phase 2 trial can’t be
overstated. Despite the prevalence of COVID-19-related mental
illness, our trial will be the first clinical trial to date of a
pharmaceutical intervention to treat COVID-19-related
immune-mediated depression.”
Aging and Lifespan
As an immuno-metabolic regulator, MYMD-1 is being developed to
target aging (such as sarcopenia and frailty) and depression in age
or inflammatory-related diseases. It also shows potential as an
anti-fibrotic and anti-prolific therapeutic.
“We are equally excited to launch a second Phase 2 trial of
MYMD-1 in the near term,” Dr. Chapman added. “With two Phase 2
trials in progress simultaneously, we are working to position
ourselves to be able to commercialize and monetize two assets with
very promising combined market value.”
About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) is a clinical stage
pharmaceutical company committed to extending healthy lifespan in
humans by focusing on developing two therapeutic platforms. MYMD-1
is a drug platform based on a clinical stage small molecule that
regulates the immunometabolic system to control TNF-α and other
pro-inflammatory cytokines. MYMD-1 is being developed to treat
autoimmune diseases, including those currently treated with
non-selective TNF-α blocking drugs, and aging and longevity. The
Company’s second drug platform, Supera-CBD, is based on a novel
synthetic derivative of cannabidiol (CBD) that targets numerous key
receptors including CB2 and opioid receptors and inhibits monoamine
oxidase. Supera-CBD is being developed to address the rapidly
growing CBD market, that includes FDA approved drugs and CBD
products not currently regulated as a drug. 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 March 31, 2021, filed by MyMD on May 18,
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 National Center for Biological Information
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Investor Contact: Robert Schatz (646) 421-9523
rschatz@mymd.com www.mymd.com
Media Contact: Will Johnson 201-465-8019
MYMD@antennagroup.com www.antennagroup.com
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