Ozanimod, a drug developed at San Diego-based Scripps Research that won FDA approval last year for relapsing forms of multiple sclerosis, has been approved for a second high-need medical condition — ulcerative colitis.
The once-daily oral drug, sold by Bristol Myers Squibb under the name Zeposia, can now be prescribed to treat adults with moderate to severe forms of the inflammatory bowel disease.
It’s the first drug in a new class of immune-modulating compounds to be approved for ulcerative colitis, which affects about 1 million people in the United States.
“For patients with ulcerative colitis, this oral drug offers a better and more convenient option to control disease progression and improve quality of life,” said Hugh Rosen, who developed ozanimod along with fellow Scripps Research professor Edward Roberts and their laboratory colleagues.
“The hope is that this will lead to fewer dangerous complications or serious infections than current treatment options, providing a steadier path for newly diagnosed patients as well as those failing other treatments,” Rosen said.
Ulcerative colitis is a relapsing, chronic autoimmune disease of the large intestine and rectum, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. The condition, as with other inflammatory bowel diseases, is driven in large part by an overactive immune response.
Ozanimod is the first in a class of drugs known as “sphingosine 1-phosphate receptor modulators” to be approved for ulcerative colitis. The drug works by binding to receptors on immune cells’ surface in the large intestine, diminishing the immune system’s ability to inflict damage.
The drug is also in late-stage clinical trials for the treatment of Crohn’s disease, another type of inflammatory bowel disease.
“It has been tremendously emotionally and intellectually satisfying for us to see this drug advance from discovery and early lab studies to regulatory approvals for multiple sclerosis, ulcerative colitis and hopefully Crohn’s disease in the future,” Rosen said. “The impact of these diseases on patients and their families cannot be overstated.”
Additional molecules developed by Rosen and Roberts at Scripps Research are currently in phase 2 clinical trials for major depressive disease and anxiety, and phase 1 studies for treatment of autism.