Bristol Myers Squibb's just-launched MS drug Zeposia makes the cut in key ulcerative colitis trial
In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.
The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.
In the over 1,000 patient trial, christened True North, Zeposia was tested against a placebo as an induction and maintenance therapy in adults with moderate-to-severe ulcerative colitis who did not derive enough benefit from previous therapy. The drug is the first S1P receptor modulator to demonstrate benefit in this category of patients in a late-stage study, Bristol Myers Squibb said on Tuesday.
The trial met both primary endpoints: the proportion of patients in clinical remission based at week 10 in the induction phase, and at week 52 for the maintenance phase. Zeposia’s effect was highly statistically significant (p-value < 0.0001) the company said, adding that the drug also met key secondary endpoints.
Detailed data from the trial, as is custom, were not provided at this stage.
Ulcerative colitis is a chronic inflammatory bowel disease and is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers in the lining of the large intestine. Apart from steroids and immunosuppressants, other treatment options include immunomodulators such as the blockbuster TNF inhibitors Remicade and Humira.
Zeposia, known chemically as ozanimod, was approved in March but was only launched days ago due to the Covid-19 outbreak. Unlike the first crop of S1P modulators that included requirements for dose titration, first dose cardiac monitoring, and other forms of clinical evaluation and/or laboratory testing, the drug’s label was relatively benign with no black box warning but with contraindications for some patients with pre-existing heart conditions.
But the MS market is crowded, and the pace of approvals in recent years has picked up, including Biogen’s Vumerity, Novartis’ Mayzent and EMD Serono’s Mavenclad. So it may be be difficult for Zeposia to make a big splash in the market. So as is the case with many other immunomodulators, the drug is being trialed for a host of other immune diseases, including ulcerative colitis and Crohn’s disease.