:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/tronc/OE2PF5VRXZE2LITKLOTCLKXX6E.jpg)
About 1.5 million Americans suffer from rheumatoid arthritis, a chronic disease in which the immune system attacks healthy cells, typically around the joints, causing swelling and deformity.
Generally, doctors prescribe the drug methotrexate, which reduces pain and swelling and can also slow joint damage and disease progression over time. But it doesn’t work for everyone.
Next, doctors often prescribe drugs such as Humira and Enbrel — from the seemingly ubiquitous TV ads — that block a molecule called tumor necrosis factor alpha, which regulates the body’s inflammatory responses. But such immunosuppressive medications can result in serious infections.
Scientists at a Baltimore-based pharmaceutical company with less than a dozen full-time employees think they’ve developed a new TNF-α blocker that is safer than others on the market because it doesn’t completely hamper the body’s immune system.
In August, the company, MyMD, announced that the U.S. Food and Drug Administration accepted its application for the new medication. That gives MyMD the green light to start planning a Phase 2 clinical trial, where it will evaluate the medication’s safety and efficacy on human patients.
The medication, MYMD-1, can be taken as a tablet, rather than injection or infusion, and its molecules are small enough to cross the blood-brain barrier and access the central nervous system. The TNF-α inhibitors currently on the market can’t cross the blood-brain barrier and have been shown to worsen central nervous system autoimmune conditions like multiple sclerosis, Dr. Adam Kaplin, MyMD’s chief scientific officer, said.
In March, the company shared data from a preclinical trial that showed that its drug more effectively reduced swelling in mice than Humira and Enbrel.
“That’s what got us the FDA approval,” Kaplin said.
:quality(70)/cloudfront-us-east-1.images.arcpublishing.com/tronc/OYMIWZBI6RGJBNGYER4KIWLKNA.jpg)
Kaplin, who has held various roles at the Johns Hopkins University since 2002 and is now an adjunct professor there, joined MyMD’s leadership team in 2020. Dr. Chris Chapman, an anesthesiologist with experience managing clinical trials around the world, is the company’s president and chief medical officer, and Jenna Brager, the former director of clinical research and scientific grants for LifeBridge Health, is its executive vice president of drug development.
MyMD started out as a small company in Florida about six years ago, before it merged with a public New York-based company to be able to trade on Wall Street, Chapman said. The company’s shares trade on the NASDAQ market and currently swap hands for about 50 cents each, though they have been well over $1 a share earlier this year.
It’s now headquartered at Johns Hopkins University’s Science and Technology Park in East Baltimore, though it isn’t affiliated with the university, and works with research laboratories elsewhere in the country.
Beyond treating autoimmune and inflammatory conditions, MyMD also aims to develop medications for age-related diseases like frailty, Kaplin said.
“One of the things I learned as a medical student is, if you used your magic wand and got rid of all cancer,” he said, “you’d extend the human life span by three years.
“You say, ‘Three years! There are all of these people dying. How is that possible?’” Kaplin continued. “It’s because once you get to a certain age, the risk of cancer goes up — but right behind it is cardiac illness and then pulmonary disease. So when one falls, the other just kicks in. It’s aging that kills us. It’s not any one thing.”
Over the summer, MyMD shared promising preliminary results from another Phase 2 clinical trial that evaluated the efficacy of MYMD-1 on treating frailty. According to a July news release, the medication could be the first to be approved by the FDA to treat the condition, which leads to greater risk of hospitalization, disability and death among older adults.
MyMD anticipates it will be able to share more detailed results from the frailty Phase 2 clinical trial in December, Chapman said. At that point, the company will decide whether to pursue a Phase 3 clinical trial for the medication — the final trial MyMD must complete before applying for FDA approval — or a Phase 2 clinical trial for the rheumatoid arthritis treatment.
Market characteristics, like the fact that there would be no competition for a drug to treat frailty, compared with the crowded field of rheumatoid arthritis treatments, will factor into the company’s decision, Chapman said.
“We are doing an assessment now, an evaluation of the company,” he said. “It’s like, ‘What is the best direction to go for the company?’ We’re taking a look at all [options].”
The Morning Sun
There has been a significant improvement in the past several years in the early diagnosis and treatment of rheumatoid arthritis, though doctors are always looking for more therapies that treat the disease with little or no side effects, said Dr. Jamal Mikdashi, a rheumatologist at the University of Maryland Medical Center and an associate professor of medicine at the University of Maryland School of Medicine.
While it’s too early to say what kind of role MYMD-1 could play in treatment of the condition, Mikdashi said he’s been following its progress. He’s especially interested in seeing data on the drug’s long-term safety and viability.
Considering the drug targets not just TNF-α, but two other molecules that regulate inflammation, it’s a “promising medicine,” Mikdashi said.
Another factor that may determine whether MYMD-1 disrupts the market for rheumatoid arthritis treatments is the price at which it will be sold to patients.
The federal government recently took action to lower the price for Humira and Enbrel, two popular TNF-α inhibitors that often retail for more than $7,000, according to GoodRx. Enbrel is on the list of drugs that will be subject to Medicare price negotiation under the Inflation Reduction Act, and the maker of Humira will be required to pay a penalty to Medicare because its price has risen faster than the rate of inflation.
At this stage in the process, it’s difficult to say exactly how affordable MYMD-1 will be for patients, Kaplin said, especially considering that a larger pharmaceutical company with the sales force needed to market the drug likely would purchase the company down the road.
But, he said, the medication should be much simpler to make, compared with other drugs on the market. Because of that, he can think of “no reason for it to be astronomically expensive.”