Ulcerative colitis (UC) new medicine! St. Squire oral S1P receptor regulator Zeposia III clinical success!

June 03, 2020 /
BiovalleyBIOON/ -- BMS recently released positive results for evaluating Zeposia (ozanimod) as an induction and maintenance therapy for moderate to severe ulcerative colonitis (UC) in adult patients with critical PHASE III NOW study (NCT02435992)The results showed that the study reached the main endpoint of induced clinical remission at the 10th week of induction and maintenance of clinical remission at the 52nd week of the induction periodIt is worth mentioning that, based on the results of this study, Zeposia is the first oral anitol-1-phosphate (S1P) receptor regulator to demonstrate clinical benefits in the treatment of moderate to severe UC in phase III studiesTRUE NORTH is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that investigated the efficacy and safety of Zeposia 1mg in moderate to severe UC patients who under-responded to previous treatmentsDuring the induction period, patients in Cohort 1 were randomly assigned at a 2:1 ratio and received Zeposia or placebo once a day for 10 weeksQueue 2 is an open label group, and the study was incorporated into the queue to allow a sufficient number of patients for a maintenance periodQueue 2 patients receivezes Zeposia once a day for 10 weekspatients who received Zeposia treatment in the 10th week of the induction period were reassigned at a 1:1 scale for the maintenance period, in queue 1 or in cohort 2, and received Zeposia or placebo treatment until week 52Patients who received placebo therapy at the induction stage and who achieved clinical remission at the 10th week continued to receive placebo during double-blind maintenanceAll eligible patients were included in an open label expansion trial, which is under way to assess the long-term efficacy of moderate to severe UC in Zeposia treatmentThe primary endpoint of thestudy was the proportion of patients with clinical remission determined by the 10th week of the induction period and the 52nd week of the maintenance period based on the comprehensive clinical and endoscopic score (3 Mayo scores)Secondary endpoints include the proportion of patients who achieved clinical responses in weeks 10 and 52, patients with endoscopy improvement in weeks 10 and 52 (endoscopic score of 1), and patients who sat for clinical remission at week 10 for clinical remissiondata showed that the study reached two major endpoints: induced clinical remission at the 10th week of the induction period, and maintenance of clinical remission at the 52nd week of the maintenance period showed high lyse results (p00001)In addition, in the 10th week of induction and the 52nd week of the maintenance period, the study also reached a critical secondary endpoint of clinical response and endoscopy improvement the study, Zeposia's safety was consistent with previous trials Boxei will complete a comprehensive assessment of the data from the TRUE NORTH study and work with investigators to release detailed results at a future medical meeting and discuss the results with regulators "It's very difficult for patients with ulcerative colitis to effectively control this often unpredictable and potentially debilitating disease," said Samit Hirawat, M.D., chief medical officer of perch The results of the TRUE NORTH study are very encouraging for patients with moderate to severe ulcerative colitis, as Zeposia exhibits consistent efficacy at key clinical and endoscopic endpoints, suggesting that Zeposia may address the need for new oral treatment stors with beneficial risks At Boxei Squibb, we are committed to researching innovative treatment seeking treatment to improve the care of patients with ulcerative colitis, with a focus on finding solutions that have the potential to transform the prognosis of the inflammatory bowel disease population "
currently, Bsusme is also conducting a Phase III YELLOWSTONE
clinical trial program to evaluate Zeposia for treatment of moderate to severe active Crohn's disease (CD) ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by an abnormal immune response that lasts for a long time and produces long-term inflammation and ulcers (ulcers) in the mucous membranes (lining) of the large intestine (colon) Symptoms include blood clots, severe diarrhea, and frequent abdominal pain, usually over time rather than suddenly UC has important impacts on patients' health-related quality of life, including physical function, social and emotional health, and ability to work Many patients have little or no response to the therapies currently available An estimated 12.6 million people worldwide suffer from IBD Zeposia's active pharmaceutical ingredient, ozanimod, is an oral pyridine-1-phosphate (S1P) receptor regulator selectively combined with S1P subtypes 1 (S1P1) and 5 (S1P5) with high affinity in the treatment of multiple sclerosis (MS), the selective binding of ozanimod S1P1 is thought to inhibit the migration of activated lymphocytes to the inflammatory region in a particular subgroup, reducing the levels of circulating T lymphocytes and B lymphocytes that can lead to anti-inflammatory activity, thereby relieving the immune system to attack the neuromyelin Due to the special mechanism of action of ozanimod, the patient's immunosurveillance function is maintained The combination of ozanimod and S1PR5 activates special cells in the central nervous system, promotes myelin regeneration, and prevents synaptic defects, ultimately preventing nerve damage With the combined effect of the two mechanisms of "reducing damage and strengthening repair", ozanimod has the potential to improve the symptoms of multiple immune diseases in March, Zeposia won the U.S FDA approved for the treatment of adult recurrent multiple sclerosis (RMS), including clinically isolated syndrome, recurrent recurrent diseases, and active secondary progressive diseases In May, Zeposia was approved by the European Commission for the treatment of adult patients with active diseases (defined as clinical or imaging characteristics) with recurrent-remission multiple sclerosis (RRMS) Zeposia was developed by Xinji, which also marks the first drug approved in the U.S and european Union by Shiguibao since it completed its acquisition of the new base, and will expand Its Shimigipot's franchise in the field of immunology Currently, St Squibb is developing Zeposia for a variety of immunoinflammatory conditions, including ulcerative colitis (UC) and Crohn's disease (CD) in addition to multiple sclerosis The mechanism by which Zeposia treats UC is unclear, but may be related to reducing the entry of lymphocytes into the inflammatory intestinal mucosa (BioValleyBioon.com) original origin: Bristol Myers Squibbs Announce Positive Topline From Pivotal Phase 3 True North Trial Ofing Zeposia (ozanimod) in Patient withs Moderate To Ulcer Severe Colitis