Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52
Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit in moderate to severe ulcerative colitis in a Phase 3 study
PRINCETON, NJ, USA I June 02, 2020 IBristol Myers Squibb (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis. True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) 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 Zeposia in the True North trial was consistent with that observed in previously reported trials. The company will complete a full evaluation of the True North data and work with investigators to present detailed results at a future medical meeting, as well as discuss these results with health authorities.
“Patients with ulcerative colitis can struggle to effectively manage this often unpredictable and potentially debilitating disease. The True North results are encouraging for patients living with moderate to severe ulcerative colitis as Zeposia demonstrated consistency across key clinical and endoscopic endpoints, suggesting Zeposia may address the need for new oral therapy options with a favorable benefit to risk profile in the treatment journey,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “At Bristol Myers Squibb, we are committed to researching innovative treatment options that may elevate the standard of care for people living with ulcerative colitis, with a focus on finding solutions that have the potential to transform outcomes for the inflammatory bowel disease community.”
Bristol Myers Squibb is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.
About True North
True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia 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 randomized 2:1 to Zeposia 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 Zeposia for 10 weeks.
For the maintenance phase, patients on Zeposia from either cohort 1 or 2 who achieved clinical response in the induction phase at Week 10 were re-randomized 1:1 to Zeposia 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 Zeposia for the treatment of moderate to severe ulcerative colitis.
The primary endpoints are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 for the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score ≤1) at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10. More information can be found on www.clinicaltrials.gov, NCT02435992.
About Ulcerative Colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon). Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to work. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that 12.6 million people worldwide have IBD.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to egress from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa.
The U.S. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020. Zeposia is also in development for additional immune-inflammatory indications, including Crohn’s disease.
U.S. FDA-APPROVED INDICATION FOR ZEPOSIA
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
For additional safety information, please see the full Prescribing Information and Medication Guide.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
SOURCE: Bristol Myers Squibb
Post Views: 23
Study met primary endpoints of clinical remission in induction at Week 10 and in maintenance at Week 52
Zeposia is the first oral sphingosine-1-phosphate (S1P) receptor modulator to demonstrate benefit in moderate to severe ulcerative colitis in a Phase 3 study
PRINCETON, NJ, USA I June 02, 2020 IBristol Myers Squibb (NYSE:BMY) today announced results from True North, a pivotal Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy for adult patients with moderate to severe ulcerative colitis. True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) 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 Zeposia in the True North trial was consistent with that observed in previously reported trials. The company will complete a full evaluation of the True North data and work with investigators to present detailed results at a future medical meeting, as well as discuss these results with health authorities.
“Patients with ulcerative colitis can struggle to effectively manage this often unpredictable and potentially debilitating disease. The True North results are encouraging for patients living with moderate to severe ulcerative colitis as Zeposia demonstrated consistency across key clinical and endoscopic endpoints, suggesting Zeposia may address the need for new oral therapy options with a favorable benefit to risk profile in the treatment journey,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “At Bristol Myers Squibb, we are committed to researching innovative treatment options that may elevate the standard of care for people living with ulcerative colitis, with a focus on finding solutions that have the potential to transform outcomes for the inflammatory bowel disease community.”
Bristol Myers Squibb is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.
About True North
True North is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of Zeposia 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 randomized 2:1 to Zeposia 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 Zeposia for 10 weeks.
For the maintenance phase, patients on Zeposia from either cohort 1 or 2 who achieved clinical response in the induction phase at Week 10 were re-randomized 1:1 to Zeposia 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 Zeposia for the treatment of moderate to severe ulcerative colitis.
The primary endpoints are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 for the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score ≤1) at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10. More information can be found on www.clinicaltrials.gov, NCT02435992.
About Ulcerative Colitis
Ulcerative colitis, a chronic inflammatory bowel disease (IBD), is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers (sores) in the mucosa (lining) of the large intestine (colon). Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to work. Many patients have an inadequate response or do not respond at all to currently available therapies. It is estimated that 12.6 million people worldwide have IBD.
About Zeposia (ozanimod)
Zeposia (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. Zeposia reduces the capacity of lymphocytes to egress from lymph nodes, reducing the number of circulating lymphocytes in peripheral blood. The mechanism by which Zeposia exerts therapeutic effects in ulcerative colitis is unknown but may involve the reduction of lymphocyte migration into the inflamed intestinal mucosa.
The U.S. Food and Drug Administration (FDA) approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020. The European Commission approved Zeposia for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features in May 2020. Zeposia is also in development for additional immune-inflammatory indications, including Crohn’s disease.
U.S. FDA-APPROVED INDICATION FOR ZEPOSIA
ZEPOSIA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
For additional safety information, please see the full Prescribing Information and Medication Guide.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
SOURCE: Bristol Myers Squibb
Post Views: 23
