MyMD Pharmaceuticals Accelerates Pace of New Patient Dosing in Phase 2 Clinical Trial of MYMD-1 as a Therapy for Delaying Aging and Extending Healthy Lifespan
April 05 2022 - 9:15AM
Business Wire
28-day dosing regimen completed by several
patients to date
Efficacy data from fully funded Phase 2 trial
is expected in first half of 2022
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the
Company”), a clinical stage pharmaceutical company committed to
extending healthy lifespan, today announced an acceleration in the
pace of new patient dosing in the Company’s fully funded Phase 2
clinical trial of lead drug candidate MYMD-1 as a therapy for
delaying aging and expanding healthy lifespan. The Phase 2
double-blind, placebo controlled, randomized study (NCT05283486)
investigates the efficacy, tolerability and pharmacokinetics of
MYMD-1 in the treatment of participants aged 65 years or older with
chronic inflammation associated with sarcopenia/frailty.
MYMD-1 is a drug platform based on a clinical stage small
molecule that regulates the immune system to control tumor necrosis
factor-alpha (TNF-α), which drives chronic inflammation, and other
pro-inflammatory cell signaling cytokines. Chronic inflammation is
a common factor in aging and all aging-related diseases including
frailty, sarcopenia (loss of muscle tissue), and autoimmunity.
“We are encouraged by the pace of enrollment in our study and
pleased with the completion of the 28-day regimen by several
patients so far,” said Chris Chapman, M.D., President, Director and
Chief Medical Officer of MyMD. “Unlike similar therapies, none of
which are FDA approved for aging and aging-related diseases, MYMD-1
is selectively immunosuppressive, dosed orally rather than by
injection, and has not been shown to cause serious side effects
common with traditional treatments for inflammation. Based on these
key differentiators and earlier outcomes in pre-clinical and
clinical trials, we are optimistic that MYMD-1 could become a first
of its kind, high-value next-generation immune regulator for
autoimmune and age-related diseases.”
MyMD representatives have stated that there are no FDA-approved
drugs for treating aging disorders and extending healthy lifespan
in humans, a market 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 approximately $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 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 in
pre-clinical studies 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 and 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.
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 Company's Annual Report on Form 10-K for
the year ended December 31, 2021, filed by MyMD on March 31, 2022.
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
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
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version on businesswire.com: https://www.businesswire.com/news/home/20220405005376/en/
Investor: Robert Schatz (646) 421-9523 rschatz@mymd.com
www.mymd.com
Media: media@mymd.com
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