Not Science Fiction Anymore? MyMD Moves Into Phase 2 Research For A Pill To Reportedly Slow Down Aging

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This post contains sponsored advertising content paid for by MyMD. This content is for informational purposes only and is not intended to be investing advice.

This month, MyMD Pharmaceuticals Inc. MYMD released data from its Phase 1 clinical trial of its immunotherapy drug candidate, MYMD-1, which is being developed as an oral treatment to slow the aging process by helping to block the process that causes loss of muscle mass and function as people get older. As the company is getting ready to enter Phase 2 clinical trials of the drug candidate, it hopes to move closer toward making MYMD-1 the first treatment to be approved by the Food and Drug Administration (FDA) to treat aging.

The Emerging Anti-Aging Drug Market

The average human lifespan is increasing, and as global populations start to live longer, consumers are demanding treatments that not only treat the conditions that can come with age but also the process of aging itself, contributing to a global anti-aging drug market that is projected to become a $600 billion market by 2025.

With high growth potential and a fragmented landscape made up of many early-stage or small biotech and pharmaceutical companies, this market has the potential to become a hotbed of innovation with some big investors.

Just this December, Brian Armstrong, co-founder of Coinbase Global Inc. COIN, and Blake Byers, a venture capitalist, pooled $105 million to found NewLimit, a startup anti-aging biotech that will focus on epigenetics and tissue regeneration in hopes of developing treatments that can “cure” aging. Last month, Altos Labs officially launched with $3 billion from a large investor base that includes Amazon.com Inc. AMZN founder Jeff Bezos.

While those companies are focused on epigenetics and cellular reprogramming—approaches to aging that might still be years away from reality because of serious concerns about safety and efficacy—one example of another possible research path is the study of Tumor Necrosis Factor alpha (TNF alpha) inhibitors to slow the aging process.

TNF Alpha Inhibitors for Aging

TNF alpha is an inflammatory cytokine that the body produces during acute inflammation. It triggers two kinds of cell death: apoptosis (an intentional and controlled “suicide” of specific cells) and necrosis (untargeted, accidental death of cells). 

In acute cases, TNF alpha is a helpful part of the body’s immune response because it can kill off infected cells before they have a chance to infect other cells. However, in chronic cases, like arthritis or inflammatory bowel disease (IBD), long-term inflammation can end up doing more harm than good — such as causing the flare-ups that make both of those chronic conditions so painful. 

However, they also play a role in aging in general, specifically in sarcopenia, the progressive loss of muscle mass and function that comes with getting older.

TNF alpha inhibitors like MYMD-1 are formulated to block these cytokines to stop the inflammation that is the root cause of so many age-related conditions and aging itself. 

The FDA has already approved some TNF inhibitors for common conditions like Crohn’s disease and plaque psoriasis. Humira, for example, is a TNF inhibitor manufactured by AbbVie Inc. ABBV approved for the treatment of both of those conditions along with a few other indications.

However, none have yet been approved for the treatment of sarcopenia, and the potential there is reportedly substantial, as the initial clinical data from MYMD-1 shows.

MYMD-1 Is Meant to Be a Better TNF Inhibitor

Existing TNF inhibitors come with some key drawbacks that make widespread adoption difficult, especially for healthy patients who would be using them to treat general aging, rather than a specific inflammatory condition. 

For one, all of the currently FDA-approved options are administered via injection or infusion. In addition to being inconvenient, injections and infusions carry a higher risk of infection and irritation. Second, because they work by blocking an immune response, they can weaken the body’s ability to naturally fight off infections, making patients more at risk of catching viral or bacterial infections. 

MYMD-1 is a TNF alpha inhibitor that isn’t immunosuppressive. The drug has been formulated to selectively block cytokine only when it becomes over-activated. At moderate levels, when it’s just doing its normal job of fighting off infections, MYMD-1 won’t block it. 

It’s also an oral drug, making it much easier to take and helping to eliminate the risks of adverse reactions to injections and infusions.

The recently released data from the Phase 1 study showed that MYMD-1 significantly decreased TNF-alpha levels in healthy human patients. The findings might represent an important breakthrough because, until now, data on TNF blockers has largely been concentrated on patients with existing conditions, like the inflammatory diseases it’s currently approved to treat. That MYMD-1 can lower TNF alpha levels in healthy patients without causing severe adverse side effects suggests that it might be safe and effective as an anti-aging treatment, even for people without chronic conditions.

These positive results along with the company’s preclinical data showing similar results have led to the FDA approving the use of TNF alpha reduction as a primary endpoint for the company’s Phase 2 trial, meaning that the drug candidate is one step closer to being specifically approved for the indication of aging. 

That Phase 2 trial is already fully funded and the company expects to have data from it during the first half of this year. 

This post contains sponsored advertising content paid for by MyMD. This content is for informational purposes only and is not intended to be investing advice.