- New data shows MYMD-1 has key differentiators and capabilities
compared to existing TNF inhibitor drugs
- Company plans to initiate Phase II trial with a leading
academic institution
MyMD Pharmaceuticals, Inc. (“MyMD”), a clinical stage
pharmaceutical company committed to extending healthy lifespan by
focusing on developing two therapeutic platforms, today announced
new data from a study conducted by Eurofins Discovery (ERF.FP)
Phenotypic Center of Excellence (“Eurofins”) comparing the
biological activities of MyMD’s lead compound MYMD-1, with leading
FDA approved TNF inhibitors (TNFi).
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MYMD-1 is being developed to treat autoimmune and age-related
diseases, and to slow aging thereby increasing life-span. The drug
has shown effectiveness in regulating the immune system, in
preclinical studies, by targeting the root causes of inflammation
and performing as a selective inhibitor of tumor necrosis
factor-alpha (TNF-a), a driver of chronic inflammation.
The recent Eurofins study found that when compared to
commercially available TNFi biological drugs, MYMD-1 had
significant activity demonstrating anti-proliferative effects – the
effect of inhibiting cell growth. Data also demonstrated that none
of the biological drugs selected for the comparison study proved to
be anti-proliferative to any of the primary cell types
assessed.
“This data continues to validate our concerted efforts to move
forward in bringing MYMD-1 to the market and its promising
potential to treat a myriad of inflammatory and autoimmune-related
diseases,” said Chris Chapman, M.D., President, Director and Chief
Medical Officer of MyMD. “We remain encouraged as we continue our
evaluations of MYMD-1 for efficacy and safety – especially as
studies continue to suggest we may be able to address many of the
concerns that are associated with the current drugs on the market
today in these disease areas.”
The current FDA approved TNFi biological drugs selected for the
comparative study treat a number of inflammatory and autoimmune
diseases, including Crohn's disease, ulcerative colitis, rheumatoid
arthritis, psoriasis, psoriatic arthritis, and more. Acumen
Research and Consulting confirmed TNF-α inhibitors are the most
prescribed drugs by revenue globally, at $40 billion per year.
“Current TNF-a inhibitors available today, while effective, come
with an array of adverse effects and concerns for patients,” said
Adam Kaplin, M.D., Ph.D, Chief Scientific Officer for MyMD. “Many
have the risk of causing neurotoxicity, as they are unable to cross
the blood–brain barrier; this is one of the key differentiators and
capabilities of MYMD-1, which crosses the blood-brain barrier. We
also found that MYMD-1’s selectivity allows it to only block
overactive TNF-a in lymphocytes that participate in autoimmune
diseases, leaving TNF-a synthesized in macrophages to be produced
to help coordinate the initial response to acute infections. This
should remove the increased risk of infection, associated with all
TNFi biological drugs used today.”
“The power of the BioMAP Platform lies in the ability to compare
a compound’s biological profile, or fingerprint, against a large
reference database of profiles from approved drugs and tool
compounds,” said Alison O’Mahony, Ph.D., Vice President of
Translational Biology at Eurofins Discovery. “These advanced
analytics provide a human-centric, data-driven approach to
phenotypic discovery for clients.”
The study was completed using the BioMAP® Diversity PLUS® Panel
for broad phenotypic profiling and screening from Eurofins
Discovery. The BioMAP Diversity PLUS Panel provides biologically
relevant in vitro models of human disease and is used to analyze
drug candidate compounds, from discovery to preclinical safety.
BioMAP Diversity PLUS systems are made of human primary cell-based
assays modeling complex tissue and disease biology of organs.
BioMAP Diversity PLUS informs a drug candidate’s potency,
selectivity, safety, mechanism of action and disease indication.
Additionally, these findings can provide actionable insights to
help progress the right molecules to further clinical testing.
MyMD will continue conducting studies with Eurofins to determine
the efficacy of MYMD-1 and its key differentiators when compared to
current drugs on the market. These efforts continue to support
MyMD’s efforts to move forward in Phase 2 clinical studies.
About MyMD Pharmaceuticals, Inc.
MyMD is a clinical stage pharmaceutical company committed to
extending healthy lifespan 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. Supera-CBD is a drug platform based on a
novel (patent pending) 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.
About Eurofins – the global leader in bio-analysis
Eurofins is testing for life. Eurofins is a global leader in
food, environment, and pharmaceutical product testing. It is also
one of the market leaders in testing and laboratory services for
genomics, discovery pharmacology, forensics, advanced material
sciences and has a rapidly developing presence in highly
specialised and molecular clinical diagnostic testing.
With over 50,000 staff across a network of more than 800
laboratories in over 50 countries, Eurofins’ companies offer a
portfolio of over 200,000 analytical methods.
Eurofins Shares are listed on Euronext Paris Stock Exchange.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210707005497/en/
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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