Bristol Myers Squibb’s MS Drug Helps Ulcerative Colitis Patients

October 15, 2020 - Bristol Myers Squibb recently announced results from a pivotal, placebo-controlled Phase 3 clinical trial evaluating its MS drug, Zeposia (ozanimod), in patients with ulcerative colitis (UC). 

The trial, True North, enrolled 645 patients to randomly receive 1 milligram of Zeposia  or a placebo. All patients had moderate to severe UC and have not adequately responded to prior treatment.

True North met both primary endpoints, showing statistically significant and clinically meaningful results for clinical remission (18.4 percent) compared to the placebo (6 percent) at induction at Week 10 and in maintenance at Week 52.

Additionally, Zeposia met secondary endpoints, such as clinical response, endoscopic improvement, and mucosal healing in induction at Week 10 and in maintenance at Week 52.

Specifically, nearly half of patients (47.8 percent) treated with Zeposia achieved clinical response at Week 10 and Week 52, while 25.9 percent of patients treated with the placebo reported the same.

But over half (54.6 percent) of patients who received Zeposia completed the study. The most common reason for discontinuation was disease relapse. 

“The data from the Zeposia True North trial demonstrate patients with moderate to severe ulcerative colitis achieved clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints,” William Sandborn, MD, chief of the division of gastroenterology and director of the inflammatory bowel disease center at University of California (UC) in San Diego Health, said in the announcement. 

“Notably, the endoscopic and histologic benefits, which can be difficult to achieve, suggest Zeposia has the potential to address the need for a safe and effective oral treatment option for this serious, chronic disease,” said Sandborn, who is also a professor of medicine at UC San Diego School of Medicine.

In patients with prior-inhibitor exposure, clinical remission was mainly seen in patients who received Zeposia over a placebo. Researchers noted that these results were not significant at Week 10. 

But at Week 52, clinical remission and response improved with Zeposia regardless of previous TNF-inhibitor use at Week 52.

In the induction period, the most common treatment-emergent adverse events for patients who received Zeposia versus the placebo were anemia, (4.2 versus 5.6 percent), nasopharyngitis (3.5 versus 1.4 percent), and headache (3.3 versus 1.9 percent).

And in the maintenance period, the most common treatment-emergent adverse events for Zeposia versus the placebo  were alanine aminotransferase increase (4.8 versus 0.4 percent) and headaches (3.5 versus 0.4 percent). 

“We look forward to working with health authorities to bring Zeposia to this patient population and remain committed to pursuing new scientific advances to help deliver transformational medicines for the gastroenterology community,” said Mary Beth Harler, MD, head of Immunology and fibrosis development, Bristol Myers Squibb.

Zeposia, developed by Celgene, is the only approved sphingosine-1-phosphate (S1P) receptor modulator that provides treatment for patients with no genetic test. Additionally,  no label-based first-dose observation is required for patients. 

Bristol Myers Squibb acquired Celgene last year.

At the beginning of June, Bristol Myers Squibb announced that Zeposia 0.92 mg for the treatment of relapsing multiple sclerosis (MS) is now commercially available in the US.

The medication is used for the treatment of relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

For people with MS, the immune system attacks the protective myelin sheath that covers the nerves, creating damaging lesions that make it harder for signals to travel between each nerve cell. 

Occasionally, the signal breakdown may lead to relapses. Zeposia blocks the capacity of lymphocytes to escape from the lymph nodes, which reduces the number of lymphocytes in the blood, Bristol Myers Squibb stated.