Looks promising
RAPID IMPROVEMENT AND REMISSION IN PATIENTS WITH REFRACTORY ULCERATIVE COLITIS AND CROHN’S COLITIS AFTER DIRECT INJECTION OF REMESTEMCEL-L BY COLONOSCOPY
Results of First Patient Cohort from Randomized Controlled Study Presented at Congress of European Crohn’s and Colitis Organisation (ECCO)
Melbourne, Australia; February 21, and New York, USA; February 20, 2022: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced positive results from an interim analysis of the first patient cohort in the randomized, controlled study of remestemcel-L by direct endoscopic delivery to areas of inflammation in patients with medically refractory ulcerative colitis or Crohn’s colitis. A single local delivery of remestemcel-L by colonoscopy resulted in rapid mucosal healing and disease remission in these refractory patients at high risk of progression to surgery.
The results of the first cohort of patients were presented at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO), February 16-19, by the trial’s lead investigator Dr. Amy L. Lightner, Associate Professor of Surgery in the Department of Colon and Rectal Surgery at Cleveland Clinic and were published in the Journal of Crohn's and Colitis. 1,2
“Mesenchymal stromal cells (remestemcel-L) offer a safe therapeutic for the treatment of medically refractory Ulcerative Colitis and Crohn’s colitis,” said Dr. Lightner. “Early data suggests improved clinical and endoscopic scores as early as two weeks following remestemcel-L delivery.”
The study at Cleveland Clinic will randomize up to 48 patients with medically refractory ulcerative colitis or Crohn’s colitis in a 2:1 fashion to receive a single intervention with remestemcel-L at a dose of 150-300 million cells or placebo delivered via direct injection using a 23 G sclerotherapy needle at the time of colonoscopy. Medically refractory ulcerative colitis and Crohn’s colitis patients are defined as having active disease for at least 6 months and having lost response to at least one monoclonal antibody (anti-TNF or anti-integrin). Medically refractory Crohn’s colitis patients exclude small bowel involvement and colorectal strictures. Outcomes are evaluated by validated endoscopic and clinical scoring systems at 2 weeks, 6 weeks, and 3 months post intervention. 3,4
Key results of the interim analysis performed in the first 12 enrolled patients were as follows:
• Colonoscopic delivery of remestemcel-L was not associated with any treatment-related adverse events
• All ulcerative colitis patients treated with remestemcel-L had improved clinical and endoscopy scores within two weeks, as defined by the Mayo clinical score and Mayo endoscopic severity (MES) score, and all achieved clinical and endoscopic remission by six weeks
• All ulcerative colitis patients were extremely satisfied or satisfied with remestemcel-L treatment at three months, based on the inflammatory bowel disease patient reported treatment impact (IBD-PRTI), and response was described as excellent or good in all patients
• All Crohn’s colitis patients treated with remestemcel-L showed treatment remissions or responses by three months, as measured by the Simple Endoscopy Score for Crohn’s Disease (SES-CD) (mean score 17 at baseline decreased to 5 at three months)
• Remestemcel-L treatment resulted in reduction of fecal calprotectin, a validated biomarker of disease activity, 5 from mean of 231 at baseline to 67 at three months, indicative of remission
• In controls with ulcerative colitis and Crohn’s colitis over three months, endoscopy scores increased, fecal calprotectin levels increased from a mean of 330 to 505, and clinical responses were described as poor or unchanged
Mesoblast Chief Medical Officer, Dr. Eric Rose said, “We are delighted to be involved with Dr. Lightner and her team at Cleveland Clinic in this latest cutting-edge study. This randomized controlled trial is the first to evaluate local delivery of remestemcel-L directly into the inflamed colon, using objective endoscopic measures of mucosal healing, in patients with colitis who are at high risk of surgical resection of their colon.”
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