Full Press Release Details
Pharmaceuticals Announces Positive Clinical Data in Advance of Upcoming Phase 2 Trial of MYMD-1 for Extending Healthy Lifespan
| Phase 1 dose-ranging study results meet primary endpoints | ||
| Drug demonstrates statistically significant efficacy in reducing levels of the root cause of aging, TNF- , in the blood | ||
| Data from fully funded Phase 2 trial anticipated in first half of 2022 |
MD. - February 8, 2022 - MyMD Pharmaceuticals, Inc. (Nasdaq:
MYMD) ("MyMD" or "the Company"), a clinical stage pharmaceutical company committed to extending healthy lifespan,
today announced Phase 1 clinical trial data demonstrating MYMD-1's reduction of tumor necrosis factor-alpha (TNF- ), the
molecules that are the root cause of aging, in the blood of healthy human subjects.
the Phase 1 study, subjects were treated with MYMD-1 or placebo and TNF-
levels were measured pre and post treatment. There was a statistically significant decrease in
TNF-alpha levels (p-value <0.05) found in MYMD-1 treated subjects, but no change in the levels in subjects given placebo. While consistent
with all of the preclinical studies of MYMD-1, this is the first demonstration in humans of the ability of MYMD-1 to decrease TNF-
Chapman, M.D., President, Director and Chief Medical Officer of MyMD, stated, "We believe that our drug's statistically significant
reduction of TNF- in the blood of healthy subjects is a great achievement in medicine because the TNF- levels in
this population were not elevated to begin with. Having demonstrated the drug's mechanism of action and efficacy in Phase 1, we
are pleased that the FDA has approved TNF- reduction as the primary endpoint for our Phase 2 trial. MYMD-1's oral delivery,
selectivity, and low toxicity as compared with other TNF- blockers, none of which are FDA-approved for aging, offers a distinctive
drug profile that we believe is vastly superior to any TNF- blocker on the market today."
Phase 1 aging data is consistent with outcomes from pre-clinical models pointing to the drug's potential role in reducing both
frailty and inflammatory cytokines. Details of the Phase 1 clinical trial design are available at clinicaltrials.gov.
has 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.
The U.S. Patent and Trademark Office (USPTO) issued U.S. Patent 11,179,382 B2, titled "Methods of Reversing Normal Aging Process
and Extending Lifespan." The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual.
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.
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.
has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis
factor-alpha (TNF- ), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these pre-clinical studies
to selectively block TNF- 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- 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.
MyMD Pharmaceuticals, Inc.
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- , 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.
October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market, Acumen Research and Consulting
Nature Aging | VOL 1 | July 2021 | p. 616-623
Statement Regarding Forward-Looking Statements
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 September 30, 2021,
filed by MyMD on November 12, 2021 (as amended on November 15, 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.