MyMD Pharmaceuticals Announces Positive Clinical Data in Advance of Upcoming Phase 2 Trial of MYMD-1 for Extending Healthy Lifespan

Rhea-AI Summary

MyMD Pharmaceuticals announced positive results from a Phase 1 study of MYMD-1, demonstrating a statistically significant reduction in TNF-α levels, a key driver of aging, in healthy subjects. The study met its primary endpoints, confirming MYMD-1's efficacy. The FDA has approved TNF-α reduction as a primary endpoint for an upcoming Phase 2 trial, anticipated to start in the first half of 2022. With a growing market for aging therapies projected to exceed $600 billion by 2025, MYMD-1 may offer a distinct profile compared to existing TNF-α blockers.

Positive

• Phase 1 study results show significant TNF-α reduction (p-value <0.05).
• FDA approval of TNF-α reduction as a primary endpoint for Phase 2 trial.
• Potential market for aging therapies is expected to exceed $600 billion by 2025.

Negative

• None.

• Phase 1 dose-ranging study results meet primary endpoints
• Drug demonstrates statistically significant efficacy in reducing levels of the root cause of aging, TNF-α, in the blood
• Data from fully funded Phase 2 trial anticipated in first half of 2022

BALTIMORE--(BUSINESS WIRE)-- 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-α), the molecules that are the root cause of aging, in the blood of healthy human subjects.

In the Phase 1 study, subjects were treated with MYMD-1 or placebo and TNF-α 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-α levels.

Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD, stated, “We believe that our drug’s statistically significant reduction of TNF-α in the blood of healthy subjects is a great achievement in medicine because the TNF-α 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-α reduction as the primary endpoint for our Phase 2 trial. MYMD-1’s oral delivery, selectivity, and low toxicity as compared with other TNF-α blockers, none of which are FDA-approved for aging, offers a distinctive drug profile that we believe is vastly superior to any TNF-α blocker on the market today.”

MYMD-1’s 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.

MyMD 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.

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 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 pre-clinical 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 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.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20220208005537/en/

Investor Contact:

Robert Schatz

(646) 421-9523

rschatz@mymd.com

www.mymd.com



Media Contact:

media@mymd.com

Source: MyMD Pharmaceuticals, Inc.

FAQ

What were the Phase 1 trial results for MYMD-1?

The Phase 1 trial results for MYMD-1 demonstrated a statistically significant reduction in TNF-α levels in healthy subjects, indicating its efficacy.

What is the significance of TNF-α in aging?

TNF-α is a cytokine linked to inflammation and aging. Lowering its levels may slow the aging process and improve health span.

When is the Phase 2 trial for MYMD-1 expected to begin?

The Phase 2 trial for MYMD-1 is anticipated to start in the first half of 2022.

How does MYMD-1 compare to existing TNF-α blockers?

MYMD-1 is designed for oral delivery and aims to selectively inhibit TNF-α without the side effects common to traditional TNF-α blockers.

What is the market potential for MYMD-1?

The market for therapies targeting aging is expected to reach at least $600 billion by 2025, providing a significant opportunity for MYMD-1.