- Next-generation and first oral TNF-α
inhibitor, which completed Phase 2 study for age-related condition
sarcopenia, represents a potentially groundbreaking advance in the
treatment of RA and disruption of a $41 billion industry
- Acceptance follows statistically significant
Phase 2 data in sarcopenia showing MYMD-1 reduced TNF-α and other
inflammatory markers common to RA, while demonstrating safety and
tolerability
- MyMD now advancing 3 clinical programs for
MyMD-1 in chronic inflammatory conditions including Sarcopenia, RA
and Hashimoto’s Thyroiditis
MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or
“the Company”), a clinical stage biopharmaceutical company
committed to developing novel therapies for age-related diseases,
autoimmune and inflammatory conditions, announced today that the
U.S. Food and Drug Administration (FDA) has accepted the Company’s
Investigational New Drug Application (IND) to evaluate the safety,
efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α
inhibitor MYMD-1® in patients with active rheumatoid arthritis
(RA). The application was based on preclinical data showing that
MYMD-1 significantly reduced swelling and other clinical arthritis
measures compared to widely used RA therapy, Enbrel® (etanercept).1
The Company plans to initiate discussions with CRO vendor IQVIA on
timing of a Phase 2 study in this indication.
MYMD-1 is an oral, next-generation TNF-α inhibitor with the
potential to transform the way TNF-α based diseases are treated due
to its selectivity and ability to cross the blood brain barrier.
Its ease of oral dosing is a significant differentiator compared to
currently available TNF-α inhibitors, all of which require delivery
by injection or infusion. MYMD-1 has also been shown to selectively
block TNF-α action where it is overactivated without preventing it
from doing its normal job of responding to routine infection.
MYMD-1 is doubly effective at inhibiting inflammation by blocking
both TNF-a and IL-6 activity, whereas currently approved anti-TNF
and anti-IL-6 treatments for RA can only target one or the other.
In addition, in early clinical studies it has not been associated
with serious side effects known to occur with traditional
immunosuppressive therapies that treat inflammation.
“FDA acceptance of an IND in RA for our next-generation oral
TNF-α inhibitor, MYMD-1, is our most significant milestone as it
adds substantial momentum to our clinical program with sufficient
funding and targets one of the largest potential market
opportunities,” said Chris Chapman, M.D., president, director, and
chief medical officer of MyMD. “We are excited to initiate
discussions with our CRO regarding a Phase 2 clinical trial in RA
and believe the statistically significant biomarker data from the
Phase 2 study in sarcopenia show MYMD-1 has the potential to
disrupt the TNF-α inhibitor market and offer therapeutic benefit to
patients with a range of chronic inflammatory conditions.”
Recently, MyMD announced positive, statistically significant
Phase 2 study results in participants with sarcopenia/frailty which
showed MYMD-1 reduced TNF-α, IL-6 and sTNFR1, biomarkers which are
common to a number of chronic inflammatory diseases, and met all
safety and tolerability endpoints. The Company plans to initiate
Phase 3 trials. If approved, MYMD-1 has the potential to be the
first drug approved by FDA for the sarcopenia, an age-related
decline in muscle mass and physical function which leads to greater
risk of hospitalization, disability, and death.
“This is significant news and suggests MYMD-1 may hold promise
to be the first oral TNF-α inhibitor and a potential future
treatment for rheumatoid arthritis,” said clinical researcher,
rheumatologist and past President of the Florida Society of
Rheumatology, Robert W. Levin, MD. “There remains a need for new
oral therapies with novel mechanism of action for patients not
served by current options and I look forward to leading upcoming
Phase 2 studies of MYMD-1 to determine its full potential in RA. I
look forward to reviewing the study outcomes.”
About Rheumatoid Arthritis
Rheumatoid arthritis, an autoimmune disorder characterized by
inflammation (painful swelling) and bone erosion, affects nearly 14
million people worldwide, including 1.5 million Americans.2
Although typically associated with older adults, RA can occur at
any age, and it is three times more likely to affect women than
men.3 TNF-α has played a central role in treatments for RA since
1998, all of which are administered via injection or infusion.
Furthermore, the burden to patients, care providers and society
is striking, with an estimated annual cost of $39.2 billion.4 The
price tag includes healthcare costs, loss of employment, costs to
employers, government and caregivers as well as costs associated
with a deterioration of quality of life, among other societal
costs.
About MYMD-1
MYMD-1, a next generation, oral selective inhibitor of tumor
necrosis factor-alpha (TNF-α), a driver of chronic inflammation,
and this drug is being studied to slow the aging process, prevent
sarcopenia and frailty, extend healthy lifespan, as well as treat
rheumatoid arthritis. Its ease of oral dosing is a significant
differentiator compared to currently available TNF-α inhibitors,
all of which require delivery by injection or infusion.
MYMD-1 has shown effectiveness in pre-clinical and clinical
studies in regulating the immune system. 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. In addition,
it has not been shown to cause serious side effects common with
traditional immunosuppressive therapies that treat
inflammation.
About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage
biopharma company developing groundbreaking therapies for the
treatment of serious and debilitating autoimmune and inflammatory
diseases. MyMD’s lead clinical candidate, MYMD-1®, is an
orally available next-generation TNF-α inhibitor with the potential
to transform the way that TNF-α based diseases are treated.
MYMD-1®, with its small molecule design, improved safety
profile and ability to cross the blood brain barrier, has the
promise to provide meaningful therapeutic solutions to patients not
served by current TNF-α inhibitors and as a potential therapy for
CNS-based inflammatory and autoimmune diseases. The company has
completed Phase 2 studies of MYMD-1® for sarcopenia/frailty,
a result of the aging process, as well as early-stage trials for
rheumatoid arthritis (RA), with the potential to expand into other
applications.
MyMD’s second therapeutic candidate is Supera-CBD, a novel,
synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times
more potent a CB2 agonist (activator) than plant-based CBD. The
U.S. Drug Enforcement Administration (DEA)’s scientific review
concluded Supera-CBD will not be considered a controlled substance
or listed chemical under the Controlled Substances Act (CSA) and
its governing regulations or require scheduling during development.
In addition to its potential role in managing addiction, anxiety,
chronic pain and seizures, Supera-CBD has also been shown to have
anti-inflammatory effects. 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 COVID-19 pandemic or
similar public health emergencies 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 Company’s
Annual Report on Form 10-K for the year ended December 31, 2022,
filed by MyMD on March 31, 2023, as may be supplemented or amended
by the Company’s Quarterly Reports on Form 10-Q. 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.
References:
1ENBREL ETANERCEPT is a registered trademark of Immunex
Corporation 2https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8352468/
3https://www.arthritis.org/diseases/rheumatoid-arthritis
4https://pubmed.ncbi.nlm.nih.gov/19908947/
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version on businesswire.com: https://www.businesswire.com/news/home/20230814042365/en/
Investor Contact: Robert Schatz (646) 421-9523
rschatz@mymd.com Media Contact: Andrea Cohen Sam Brown, Inc.
(917) 209 7163 andreacohen@sambrown.com
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