Q&A: Zeposia may be efficacious oral therapy for UC
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Zeposia may be an efficacious new oral therapy option with a favorable risk-benefit profile for patients with ulcerative colitis.
Bristol Myers Squibb recently announced results from the pivotal phase 3 trial, True North, which assessed oral Zeposia (ozanimod, Bristol Myers Squibb) as an induction and maintenance therapy for adult patients with moderate to severe UC, according to a press release
True North met the primary endpoints at week 52 and demonstrated statistically significant results for induction and maintenance in adults with UC. Healio Gastroenterology spoke with William J. Sandborn, MD, chief of the division of gastroenterology, University of California, San Diego, regarding the design of the trial and its results.
Healio: What was the purpose/design of the trial?
Sandborn: The True North study was a pivotal phase 3 trial evaluating ozanimod as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis.
Regarding study design, True North was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of ozanimod 1mg in patients with moderate to severe ulcerative colitis who did not adequately respond to prior treatment. In the induction phase, cohort 1 patients were randomly assigned 2:1 to ozanimod or placebo and treated once daily for 10 weeks. Cohort 2 was an open label arm and included to allow adequate patient numbers for the maintenance phase of the trial. Cohort 2 patients were treated once daily with ozanimod for 10 weeks.
For the maintenance phase, patients on ozanimod from either cohort 1 or 2 who achieved clinical response in the induction phase at week 10 were re-randomized 1:1 to ozanimod or placebo through week 52. Patients on placebo who achieved clinical response in the induction phase at week 10 remained on placebo during this blinded maintenance phase.
All eligible patients were rolled into an open-label extension trial, which is ongoing and designed to assess the longer-term profile of ozanimod for the treatment of moderate to severe ulcerative colitis.
Healio: What were the results and conclusion of the study?
Sandborn: True North met both primary endpoints, demonstrating highly statistically significant (P < .0001) results for induction of clinical remission at week 10 and in maintenance at week 52. The study also met key secondary endpoints of clinical response and endoscopic improvement in induction at week 10 and in maintenance at week 52. The safety profile of ozanimod in the True North trial was consistent with that observed in previously reported trials.
Findings show that ozanimod demonstrated consistent improvements across clinical and endoscopic endpoints including induction (week 10) and maintenance (week 52). These findings suggest ozanimod may address the need for a new oral therapy option with durable efficacy and a favorable risk-benefit profile in ulcerative colitis patients.
Healio: Did the results impact treatment of UC?
Sandborn: The results are encouraging for patients living with moderate to severe UC, who may struggle to effectively manage this often unpredictable and potentially debilitating disease. Results show that ozanimod demonstrated consistency across clinical and endoscopic endpoints, suggesting that ozanimod may address the need for a new oral therapy option with durable efficacy and a favorable risk-benefit profile.
Healio: What is the take-home message?
Sandborn: UC is a chronic disease that often requires multiple therapies to manage. There is a need for effective, durable therapies that offer an improved safety profile and convenient administration in the treatment journey. Study results suggest that ozanimod may address the need for a new oral therapy option with durable efficacy and a favorable risk-benefit profile.
Healio: What is the next step in research?
Sandborn: As a next step, based on a full evaluation of the True North data, I will work with Bristol Myers Squibb and other investigators to present detailed results at a future medical meeting. From there, as disclosed by Bristol Myers Squibb, the company will discuss the study findings with health authorities.
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