- MYMD-1 significantly reduced serum levels of
chronic inflammatory markers and met all primary pharmacokinetic
and secondary safety and tolerability endpoints across multiple
doses over 28 days of treatment
- MYMD-1 demonstrated statistical significance
across three biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6
(P=0.03)
- First Oral TNF-α inhibitor, if approved,
would offer potential patient benefit in large markets
- Company to present the data to FDA and
intends to advance the clinical program for MYMD-1; will hold
conference call on August 2, 2023, at 4:30 PM Eastern Time
MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or the
“Company”), a clinical stage pharmaceutical company committed to
developing novel therapies for age-related diseases, autoimmune and
inflammatory conditions, today announced statistically significant
positive topline results from its randomized Phase 2 study of oral
TNF-α inhibitor, MYMD-1® in patients with chronic inflammation
associated with sarcopenia, or age-related frailty. The study met
its primary endpoints of significantly reducing chronic
inflammatory markers in participants treated with MYMD-1. MYMD-1
has the potential to be the first drug approved by the United
States Food and Drug Administration (FDA) for sarcopenia, an
age-related decline in physical function which leads to greater
risk of hospitalization, disability, and death.
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The study met both of its primary endpoints, significantly
reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1
(P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma
concentrations and parameters in pharmacokinetic evaluations. The
study also achieved all secondary endpoints related to safety and
tolerability. There were no treatment-related adverse events (AEs)
or serious adverse events (SAEs) over the course of the study.
“We are very excited about these results indicating MYMD-1
demonstrated statistically significant reductions in all three
inflammatory markers and met all additional pharmacokinetic and
safety endpoints needed to advance our sarcopenia clinical program,
with guidance from the FDA,” said Chris Chapman, M.D., President,
Director, and Chief Medical Officer at MyMD. “These results support
the unique advantages of MYMD-1 as the first oral, selective TNF-α
inhibitor candidate and potential future treatment option for
sarcopenia and other autoimmune conditions such as rheumatoid
arthritis.”
The Phase 2 multi-center double-blind, placebo controlled,
randomized study (NCT05283486) was designed to investigate the
efficacy, tolerability and pharmacokinetics of MYMD-1 in
participants aged 65 years or older with chronic inflammation
associated with sarcopenia/frailty, a condition linked to elevated
levels of proinflammatory cytokines. Patients in the study were
dosed weekly with MYMD-1 or placebo over a 28-day period. The study
consisted of four dosing cohorts versus placebo (600mg, 750mg,
900mg and 1050mg).
“We are encouraged by the reduction of inflammatory markers
along with the favorable safety profile demonstrated in this study
of an oral TNF-α inhibitor,” continued Dr. Chapman. “Sarcopenia can
significantly affect people as they age, and there are currently no
approved treatments for the condition. A selective, oral treatment
that reduces TNF-α and inflammation and does not require infusion
or injection would be a welcome advance for this population.”
Full results from the study will be presented or published at a
later date to be determined. The company plans to initiate
discussions with the FDA regarding a Phase 3 study of MYMD-1 in
sarcopenia.
Conference Call Information MyMD management will host a
conference call on Wednesday, August 2, 2023, at 4:30 PM ET. The
webcast can be accessed under the ‘Events & Presentations’
section on the Investors page at www.MYMD.com. A replay of the
webcast will be archived on the MyMD website for 30 days. Dial-in
information for conference participants may be obtained by
registering for the event here.
About MYMD-1 MYMD-1, a next generation, oral selective
inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of
chronic inflammation, is being studied to slow the aging process,
prevent sarcopenia and frailty, and extend healthy lifespan. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230731983609/en/
Investors: Robert Schatz (646) 421-9523
rschatz@mymd.com
Media: Christy Curran Sam Brown, Inc. (615) 414-8668
christycurran@sambrown.com
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