Bristol Myers Squibb’s Zeposia shows promising results in phase 3 True North trial for ulcerative colitis treatment

Bristol Myers Squibb (BMS) has reported significant success in its phase 3 True North clinical trial, evaluating the efficacy of Zeposia (ozanimod) as an oral therapy for patients with moderate to severe ulcerative colitis (UC). The trial, a placebo-controlled study involving 645 adult participants, focused on both induction and maintenance treatment for this chronic inflammatory bowel disease (IBD). The results are seen as a major breakthrough for UC treatment, which has long been challenging to manage effectively with existing therapies.

Zeposia’s phase 3 trial results: A turning point for ulcerative colitis management

Zeposia, a sphingosine-1-phosphate (S1P) receptor modulator, was approved by the US Food and Drug Administration (FDA) in March 2020 for the treatment of relapsing forms of multiple sclerosis (MS). The True North clinical trial marks a significant expansion of Zeposia’s clinical applications, now targeting ulcerative colitis, a debilitating condition characterized by chronic inflammation in the colon and rectum.

The trial’s results were highly promising, with Zeposia meeting both its primary and key secondary endpoints. At week 10, induction therapy with Zeposia resulted in 18.4% of patients achieving clinical remission, compared to only 6.0% of those receiving a placebo. The gap widened at week 52, with 37.0% of patients in the Zeposia group achieving clinical remission versus 18.5% in the placebo group.

In addition to these impressive remission rates, Zeposia also demonstrated significant improvements in secondary endpoints, such as clinical response, endoscopic improvement, and mucosal healing. By week 10, 47.8% of Zeposia-treated patients had a clinical response, compared to 25.9% in the placebo group. At week 52, this response rate increased to 60.0% for Zeposia-treated patients, compared to 41.0% for placebo.

Expert insights on Zeposia’s potential in ulcerative colitis treatment

The clinical significance of Zeposia’s results has garnered praise from leading experts in the field. Dr. William Sandborn, Chief of the Division of Gastroenterology and Director of the Inflammatory Bowel Disease Center at University of California, San Diego Health, emphasized the importance of these findings. According to Dr. Sandborn, the data from the True North trial “demonstrate clinically meaningful improvements in key clinical, endoscopic, and mucosal healing endpoints for patients with moderate to severe ulcerative colitis.”

Dr. Sandborn also highlighted the significance of the observed endoscopic and histologic benefits, which can be particularly difficult to achieve in this patient population. These findings suggest that Zeposia could address a critical need for a safe and effective oral treatment for ulcerative colitis, offering a potentially game-changing option for patients who currently face limited treatment choices.

Safety profile and next steps for Zeposia

Regarding safety, Zeposia demonstrated a safety profile consistent with its known profile in other indications, such as multiple sclerosis. No new safety concerns were raised during the True North trial, with the overall safety being in line with expectations for patients with moderate to severe ulcerative colitis.

Bristol Myers Squibb is optimistic about the potential for Zeposia to transform the treatment landscape for ulcerative colitis. Mary Beth Harler, Head of Immunology and Fibrosis Development at BMS, expressed the company’s commitment to bringing Zeposia to patients with UC, especially those who have not responded to current therapies. Harler noted, “These 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.”

Zeposia’s future in ulcerative colitis treatment

As the results of the True North trial are reviewed by regulatory authorities, BMS looks forward to expanding Zeposia’s indications to include ulcerative colitis. This development is expected to significantly enhance treatment options for patients suffering from this chronic condition.

The success of Zeposia in this trial aligns with the increasing demand for effective oral therapies for inflammatory bowel diseases, which often require patients to endure complex, invasive treatments. Zeposia’s ability to offer both induction and maintenance treatment in a single oral dose could revolutionize the way UC is managed, giving hope to millions of patients worldwide.