Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult patients with moderate to severe ulcerative colitis (UC). True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 (18.4% versus 6.0%; p-value<0.0001) and in maintenance at Week 52 (37.0% vs 18.5%; p<0.0001). The study also met key secondary endpoints, including clinical response, endoscopic improvement and mucosal healing in induction at Week 10 and in maintenance at Week 52. Significantly more patients treated with Zeposia compared to placebo achieved clinical response at Week 10 (47.8% vs 25.9%; p<0.0001) and at Week 52 (60.0% vs 41.0%; p<0.0001) with consistent results across sub-analyses. The overall safety observed was consistent with the known safety profile for Zeposia and patients with moderate to severe UC.
Efficacy and safety results from the 10-week induction period (Abstract LB02, UEG Research Prize 2020 Session) and from the maintenance period at Week 52 (Abstract LB10) from True North will be presented on October 11 at 12:32 CEST and at 15:24 CEST, respectively, in two late-breaking oral presentations at UEG Week Virtual 2020.
All key secondary efficacy endpoints showed statistically significant improvements for patients treated with Zeposia compared to placebo at Week 10 and Week 52. Findings include:
- At Week 10, key secondary endpoints were highly statistically significant and showed more patients treated with Zeposiaachieved clinical response, endoscopic improvement and mucosal healing compared to placebo.
- In patients with prior TNF-inhibitor exposure, clinical remission results favoured Zeposiaover placebo, but findings were not significant at Week 10. A nominally statistically significant difference was observed for clinical response (p=0.008).
- At Week 52, highly statistically significant results were achieved for patients treated with Zeposiacompared to placebo, including clinical response, endoscopic improvement, maintenance of remission, corticosteroid-free remission, mucosal healing and durable remission.
- Clinical remission and response improved with Zeposiaregardless of previous TNF-inhibitor use at Week 52.
In the induction period, the most common treatment-emergent adverse events (TEAEs) for patients who received Zeposia versus placebo, respectively, were anaemia (4.2% vs 5.6%), nasopharyngitis (3.5% vs 1.4%) and headache (3.3% vs 1.9%). In the maintenance period, the most common TEAEs for Zeposia versus placebo, respectively, were alanine aminotransferase increase (4.8% vs 0.4%; no serious events), and headache (3.5% vs 0.4%).