Therapy Areas: Central Nervous System
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
6 April 2022 - - US-based clinical stage pharmaceutical company MyMD Pharmaceuticals, Inc. (NASDAQ: MYMD) has accelerated the pace of new patient dosing in its fully funded Phase 2 clinical trial of lead drug candidate MYMD-1 as a therapy for delaying aging and expanding healthy lifespan, the company said.

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.

MyMD representatives have said that there are no FDA-approved drugs for treating aging disorders and extending healthy lifespan in humans, a market expected to be at least USD 600bn by 20251 according to a major investment bank.

TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately USD 40bn per year, and, according to Nature Aging journal, a slowdown in aging that would increase life expectancy by one year is worth USD 38tn and by 10 years is worth USD 367tn.

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, 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 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.

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 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.


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