ULCERATIVE COLITIS

Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential

Retrieved on: 
Tuesday, March 29, 2022
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The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23.

Key Points: 
  • The positive 12- and 52-week results from ELEVATE UC 52 follow the recent announcement of positive 12-week findings from the ELEVATE UC 12 trial on March 23.
  • Etrasimod demonstrated a safety profile consistent with previous studies, including the Phase 2 OASIS trial.
  • These data underscore etrasimods potential, if approved, as a best-in-class therapy, said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
  • Etrasimod can potentially provide a new, once-daily, oral option with a rapid onset of action and without first dose titration.

Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

Retrieved on: 
Wednesday, March 23, 2022
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In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo.

Key Points: 
  • In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo.
  • These positive results demonstrate that etrasimod, if approved, could be a potential breakthrough option for patients with ulcerative colitis who arent able to experience improvement on current therapies, said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.
  • These data along with results from ELEVATE 52 are expected to form the basis for planned future regulatory filings.
  • Available at: Quality of life of patients with ulcerative colitis: Past, present, and future | Inflammatory Bowel Diseases | Oxford Academic (openathens.net) .

Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Thursday, February 17, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Other Health, True North, Ulcerative Colitis, Zeposia (ozanimod), Bristol Myers Squibb, TRUE NORTH, ULCERATIVE COLITIS, ZEPOSIA (OZANIMOD), BRISTOL MYERS SQUIBB

Bristol Myers Squibb (NYSE: BMY) today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC).

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced interim results from the True North open-label extension study evaluating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with moderately to severely active ulcerative colitis (UC).
  • Visit this page on BMS.com for more information on Bristol Myers Squibbs scientific approach and resources on gastrointestinal immune-mediated diseases.
  • In the maintenance phase, the overall safety profile was consistent with the known safety profile for Zeposia and patients with moderate to severe UC.
  • For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .

Bristol Myers Squibb Receives European Commission Approval of Zeposia (ozanimod) for use in Adults with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Tuesday, November 23, 2021
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The most common adverse reactions leading to discontinuation were related to liver enzyme elevations (1.1%) in the MS clinical studies.

Key Points: 
  • The most common adverse reactions leading to discontinuation were related to liver enzyme elevations (1.1%) in the MS clinical studies.
  • Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.
  • Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active UC.
  • The company is also investigating Zeposia for the treatment of moderately to severely active Crohns disease in the ongoing Phase 3 YELLOWSTONE clinical trial program.

Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (ozanimod) as a Treatment for Adult Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Friday, October 15, 2021
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The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.

Key Points: 
  • The CHMP adopted this positive opinion based on data from True North, a pivotal Phase 3 trial evaluating Zeposia as an induction and maintenance therapy versus placebo in adult patients with moderately to severely active UC.
  • The U.S. Food and Drug Administration approved Zeposia for the treatment of adults with moderately to severely active UC on May 27, 2021.
  • Bristol Myers Squibb thanks the patients and investigators involved in the True North clinical trial.
  • Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.

Bristol Myers Squibb Provides Update on Phase 2 Study of Deucravacitinib in Patients With Moderate to Severe Ulcerative Colitis

Retrieved on: 
Thursday, October 7, 2021
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Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.

Key Points: 
  • Bristol Myers Squibb would like to thank the patients and investigators who were involved in the LATTICE-UC clinical trial.
  • Bristol Myers Squibb continues to expect greater than $4 billion non-risk adjusted revenue target for deucravacitinib in 2029.
  • LATTICE-UC (IM011-024) is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety and efficacy of deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
  • IM011-127 is a Phase 2, randomized, placebo-controlled, multicenter study evaluating the safety, efficacy and biomarker response of deucravacitinib in participants with moderate to severe ulcerative colitis (UC).

Bristol Myers Squibb Presents New Data at Digestive Disease Week® on Zeposia (ozanimod) Highlighting Clinical Benefits and Safety Profile in Patients with Ulcerative Colitis

Retrieved on: 
Sunday, May 23, 2021
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Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.

Key Points: 
  • Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.
  • Patients discontinuing treatment due to TEAEs included 3 patients receiving Zeposia and 6 patients receiving placebo; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation.
  • 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.
  • The European Medicines Agency validated Bristol Myers Squibb\xe2\x80\x99s Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.