New Trial Tests Cannabis-Imitating Drug That Could Replace Prednisone

An ongoing clinical trial is testing a drug that mimics the anti-inflammatory benefits of cannabis in people with lupus. The lead researcher behind the trial is hopeful the new drug may replace prednisone for lupus patients (and others with autoimmune conditions) — with way less side effects.

What Is Lupus?

Lupus is an autoimmune condition that causes the immune system to mistakenly attack healthy tissues and organs in the body such as the joints, skin, kidneys, heart and lungs, among others. While lupus causes a wide range of symptoms, the most common include fatigue, joint pain and a butterfly rash on the face. There are several forms of lupus, the most common type being systemic lupus erythematosus (SLE).

Like other autoimmune diseases, patients with lupus often rely on steroids like prednisone for its anti-inflammatory or immunosuppressive properties to help manage their symptoms. For many people, drugs like prednisone make a world of difference in their quality of life. Prednisone, however, also causes a range of difficult side effects that can be difficult to live with and cause permanent damage to the body over time. As Mighty contributor Rosie Koina shared:

I consider prednisone to be a necessary evil in my life. It is essential but the cost is rather monstrous. It is a wonderful, indispensable drug with quite awful side effects. I so wish I didn’t need to take it!

Some of the most common short- and long-term side effects of prednisone include:

• Swelling
• Weight gain
• Difficulty sleeping
• Acne
• Tremors
• Mood changes
• Eye problems
• High blood pressure
• Bone thinning or bone loss
• Lowered immunity and increased risk of infection

Finding a way to reduce the need for prednisone is one reason why Meggan Mackay, M.D., professor and rheumatologist at the Feinstein Institutes Lupus Center of Excellence, said she’s been working to get lenabasum into clinical trials for lupus since 2005.

What Is Lenabasum?

Led by Mackay, the new clinical trial is testing a medication called lenabasum (ajulemic acid/JBT-101). Lenabasum is a drug with a chemical structure similar to tetrahydrocannabinol (THC) found in marijuana, except it doesn’t cause psychotropic effects or a “high.” According to Mackay, lenabasum has been in development for 20 to 30 years, and is based on the long-standing knowledge that cannabis has anti-inflammatory properties.

“It’s a drug that’s synthesized in the laboratory, so it’s not from the plant,” Mackay told The Mighty. “But it does have similar, if not more powerful, anti-inflammatory effects. And that’s actually been known about cannabis, the plant, going back a long, long, long time. Even in old Chinese literature, there’s evidence that people have used it as an anti-inflammatory medication.”

Lenabasum works by binding to type 2 cannabinoid receptors throughout your body. From there, it packs a one-two punch: It prevents and shuts down the release of proteins that cause a big inflammatory response. Lenabasum also “turns on different pathways that work in a very natural way to promote the resolution of inflammation,” Dr. Mackay said. The drug reduces inflammation and turns on anti-inflammatory responses with, so far, fewer side effects than steroids like prednisone.

“The drug appears to be very stable and it has powerful anti-inflammatory properties,” Mackay said. “From my perspective, it seems to me that this drug may have a role in being used almost as a steroid alternative in those patients who can never get off the prednisone.”

Lenabasum Clinical Trial for Lupus

Mackay and her team at the Feinstein Institutes Lupus Center of Excellence began recruiting lupus patients for an ongoing lenabasum clinical trial in late 2017. The clinical trial is funded by the National Institutes of Health (NIH). Across 16 study sites, participants with lupus and active arthritis will either take lenabasum or a placebo (they won’t know which they are getting) throughout the three-month study period. The primary metric Mackay’s team tracks is patient-reported pain levels.

“The primary outcome measure is actually pain, so we’re relying on our patients,” Mackay said. “They call in every night, tell us zero to 10, what is their highest level of pain that day, and that will be our primary outcome measure. Then we’re also measuring obviously the physician’s assessment and their joint counts, other lupus activity and safety parameters.”

Though lenabasum sounds like a promising development for people with lupus and autoimmune diseases, it will likely be at least seven years before the drug could be available to patients, if it makes it through clinical trials. There are three phases of clinical trials a drug must move through in order to reach the Food and Drug Administration (FDA) for approval. Mackay’s double-blind, placebo trial is a phase 2 investigation.

One other challenge researchers face is that even though lenabasum is not made from cannabis, the drug is still classified like marijuana by the Drug Enforcement Administration (DEA). Lenabasum has been lumped in with other schedule 1 drugs, which includes not only marijuana but also heroin, ecstasy and LSD. Mackay needed special approval and licenses for all the trial’s site locations to administer lenabasum.

The maker of lenabasum, Corbus Pharmaceuticals, is also supporting clinical trials of the drug for other inflammatory conditions. This includes the autoimmune condition systemic sclerosis (scleroderma), the inflammatory muscle condition dermatomyositis, and cystic fibrosis. Corbus trials to test lenabasum for scleroderma and dermatomyositis are currently in phase 3. This means if the drug succeeds, lenabasum could be FDA-approved sooner for these conditions.

How You Can Help

Currently, Mackay’s team has enrolled 86 out of the 100 patients needed to start crunching the numbers on lenabasum for lupus to determine if they can move to the next step toward getting the drug FDA-approved. Patient participation in clinical trials is critical to the process of getting new treatments approved.

“The health and quality of life for millions has been improved because of advances resulting from the willingness of people to take part in clinical research,” Nikita Curry, MHA, supervisor of the Office of Patient Recruitment at the National Institutes of Health (NIH) Clinical Center, previously told The Mighty. “I can’t emphasize enough that they are both our patients AND our partners in the quest for cures.”

Mackay is hopeful that lenabasum will prove to be an effective treatment for lupus and other conditions impacted by an overactive immune system and inflammation. And, of course, she hopes it can reduce how much prednisone patients need to take in the future.

“That would be huge for our patients,” she said.

If you have lupus and active arthritis and want to learn how you can participate in Mackay’s lenabasum trial, call lead coordinator Andrew Shaw at 516-562-2591 for more info. You can also view details about the trial on ClinicalTrials.gov.