BALTIMORE–(BUSINESS WIRE)–MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical-stage pharmaceutical company focused on the development of novel therapies for age-related diseases, autoimmune diseases and inflammatory diseases, today announced the release of data in the Journal of Gerontology: Biological Sciences (JGBS) from a preclinical study of MYMD-1® It showed four times greater improvements than rapamycin in delaying aging and extending life in mice that started treatment at the human equivalent of 60 years. The study was led by the study leader Patrizio P. Caturegli, MD, MPH, Professor of Pathology at Johns Hopkins University School of Medicine.
“We are very pleased that this important early data on our lead compound MYMD-1 has been published in a prestigious medical journal,” said Chris Chapman, MD, President, Director and CMO of MyMD Pharmaceuticals. “These results further confirm the potential of MYMD-1 in delaying aging. Our ongoing Phase 2 study of MYMD-1 in sarcopenia/frailty secondary to pathologic aging is going well. Because TNF-alpha plays a key role in the aging process, we also believe that MYMD-1 has real potential to combat autoimmune and inflammatory diseases by modulating inflammation, even when initiated at an advanced age.”
MYMD-1, an oral selective inhibitor of tumor necrosis factor alpha (TNF-α), which drives chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and prolong healthy lifespans. A phase 2, multi-center, double-blind, placebo-controlled, randomized study (NCT05283486) is ongoing to evaluate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty. The company’s Scientific Advisory Board recently met and agreed to move the study to the next higher dose.
Aging is closely associated with multiple morbidities, frailty and death from conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic or autoimmune diseases.I Similarly, frailty, or a decline in physical function that leads to a higher risk of hospitalization, disability, and death, increases with age, regardless of underlying medical conditions or demographic characteristics.ii
Results of the JGBS study
The study compared MYMD-1, an oral inhibitor of TNF-α, to rapamycin, the best-characterized drug with anti-aging properties. in vivo, a longitudinal cohort of C57BL/6 mice, were randomized to receive either MYMD-1, high-dose rapamycin, or low-dose rapamycin plus metformin. Each of these three treatment arms with 18 mice (10 females and 8 males) was followed for 13 months or until death. Longevity was higher in the MYMD-1 group compared to rapamycin (p=0.019 versus high dose and p=0.01 versus low dose) in a Cox survival model that accounted for gender and serum levels of IL-6, TNF-α , significantly longer and IL-17A (see figure above). MyMD-1 also improved several health span characteristics in the study, resulting in less body weight loss, maintenance of greater muscle strength, and improvement in frailty progression.
Additionally, with a panel of 12 human primary cell systems (BioMAP Diversity PLUSTM), in which a total of 148 biomarkers were measured, MYMD-1 had antiproliferative, anti-inflammatory and antifibrotic properties. Many were shared with rapamycin, but MYMD-1 was more active at inhibiting pro-inflammatory cytokines and profibrotic biomarkers.
MYMD-1, an 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 prolong healthy lifespan. MYMD-1 has shown efficacy in regulating the immune system in preclinical and clinical studies. Unlike other therapies, these studies have shown that MYMD-1 selectively blocks TNF-α when it becomes overactivated in autoimmune disorders and cytokine storms, but does not prevent it from performing its normal role as a first responder for any type of routine moderation meet infection.
The ease of oral dosing of MYMD-1 is another differentiator compared to currently available TNF-α blockers, all of which require administration by injection or infusion. No approved TNF inhibitor has ever been administered orally. Additionally, the drug is not immunosuppressive and has not been shown to cause the serious side effects common to traditional therapies used to treat inflammation. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned as a potential treatment for brain disorders. Its mechanism of action and effectiveness in diseases such as multiple sclerosis (MS) and thyroiditis have been studied in collaboration with several academic institutions.
About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical-stage pharmaceutical company dedicated to developing novel therapies for autoimmune and inflammatory diseases, is focused on developing two novel therapeutic platforms that treat the causes of disease, rather than just fighting 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. 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 enhance the fast-growing CBD market, which includes both FDA-approved medicinal products and CBD products that are not currently regulated as medicinal products . Visit www.mymd.com for more information.
Cautionary Note 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 that could cause actual results, performance or achievements to differ materially from anticipated future results, performance or achievements. Forward-looking statements speak only as of the date on which they are made, and neither MyMD nor its affiliates undertake any obligation to update any forward-looking statements. Words like “anticipate”, “believe”, “could”, “estimate”, “expect”, “can”, “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 in such forward-looking statements include: the timing and ability of MyMD 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 funding MyMD requires for its pharmaceutical candidates; increased competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract executives and other key employees; MyMD’s ability to respond quickly and effectively to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, to operate without infringing on the proprietary rights of others, and to prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s operating results, business plan and global economy. A discussion of these and other factors relating to MyMD is contained 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 on which 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.
I St Sauver JL, Boyd CM, Grossardt BR, Bobo WV, Finney Rutten LJ, Roger VLet al. Risk of developing multimorbidity across all age groups in a historical cohort study: differences by gender and ethnicity. BMJ open. 2015;5:e006413.
ii Kochanek KD, Murphy SL, Xu J, Arias E. Deaths: Final Data for 2017. Natl Vital Stat Rep. 2019;68:1-77.