AZRX - AzurRx completes enrollment in mid-stage MS1819 combo cystic fibrosis trial
AzurRx BioPharma (AZRX) has completed enrollment in its Phase 2 trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme replacement therapy ((PERT)), for the treatment of severe exocrine pancreatic insufficiency ((EPI)) in patients with cystic fibrosis ((CF)).The Phase 2 combination clinical trial of MS1819 is a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of the treatment, in conjunction with a stable dose of PERT in order to increase the patient’s coefficient of fat absorption ((CFA)) levels and relieve abdominal symptoms.The study enrolled 18 patients, 12 years of age or older, with severe EPI.The primary efficacy endpoint of the trial is improvement in CFA; secondary endpoints of the study are improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.Previously reported results from the initial five patients in the trial revealed
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AzurRx completes enrollment in mid-stage MS1819 combo cystic fibrosis trial