Zeposia met both primary and secondary efficacy endpoints in the clinical trial and showed statistically significant improvements


Bristol-Myers Squibb in research campus in Lawrenceville, New Jersey. (Credit: Coolcaesar/Wikipedia.)

Bristol Myers Squibb has unveiled results from its Phase 3 True North clinical trial, evaluating Zeposia (ozanimod) as an oral induction and maintenance therapy for moderate to severe ulcerative colitis (UC) in adults.

The US drugmaker said that the late-stage clinical trial has met both primary endpoints, showing statistically significant and clinically meaningful results compared to placebo across induction at Week 10 and in maintenance at Week 52.

Also, the clinical trial met important secondary endpoints, including clinical response, endoscopic improvement and mucosal healing in induction at Week 10 and in maintenance at Week 52.

University of California (UC) San Diego school of medicine professor of medicine William Sandborn said: “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.

“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.”

True North is a Phase 3, multicentre, randomised, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Zeposia 1mg in patients with moderate to severe ulcerative colitis who did not adequately respond to prior treatment.

A total of 645 patients were randomised to receive Zeposia or placebo in the induction phase, and 457 patients were re-randomised for maintenance treatment.

Zeposia was effective in UC patients with consistent results across sub-analyses

In the True North study, treatment using Zeposia was effective in more number of patients with moderate to severe UC than placebo, with consistent results across sub-analyses. The overall safety was consistent with the known safety profile for the drug.

The most common treatment-emergent adverse events (TEAEs) in patients who received Zeposia, in the induction period include anaemia, nasopharyngitis and headache, while alanine aminotransferase increase and headache in the maintenance period.

Bristol Myers Squibb immunology and fibrosis development head Mary Beth Harler said: “These Zeposia True North results represent a meaningful achievement for patients living with ulcerative colitis, many of whom have an inadequate response or do not respond at all to currently available therapies.

“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.”

Zeposia was approved in US to treat RMS, and in EU to treat RRMS

Zeposia (ozanimod) is an oral, sphingosine-1-phosphate (S1P) receptor modulator, designed to bind to S1P receptors 1 and 5, with high affinity, to reduce the lymphocytes’ capacity to leave from lymph nodes, and lower their number in peripheral blood.

In March 2020, the US Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

In May 2020, the drug has received the EC approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

Furthermore, the company is currently studying Zeposia for the treatment of moderately to severely active Crohn’s disease in the Phase 3 YELLOWSTONE clinical trial programme.