21, 2016 (GLOBE NEWSWIRE) — AzurRx BioPharma, Inc. ( AZRX ) (AzurRx or the Company), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, announced today that in partnership with Mayoly Spindler, a European pharmaceutical company,that the first three patients in the Phase IIa clinical trial with MS1819-SD for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) have been enrolled. you can check hereThe open-label, dose escalation Phase II study is being conducted in two sites in Australia, The Royal Adelaide Hospital and Linear Clinical Research in Perth, as well as two sites in New Zealand, P3 Research in Wellington and CCST in Christchurch. The study is projected to complete 12-15 patients with EPI caused by chronic pancreatitis over the next several months. The primary objective of this Phase II study is to investigate the safety of escalating doses of MS1819-SD in patients with CP. The secondary objective is to investigate the efficacy dose response of MS1819-SD in these patients by analysis of the coefficient of fat absorption (CFA) and its change from baseline. http://hudsonalexandertime.azcra.org/2016/12/07/a-quick-a-z-on-speedy-tactics-for-examination-for-paediatricsSafety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests. The Company anticipates reporting data periodically during this trial, with results from the first group of patients enrolled expected to be reported in the first half of 2017. Thijs Spoor, President and CEO of AzurRx, said The enrollment of the first patient/first patients in our Phase II study is a significant milestone in the clinical development of MS1819. We look forward to further demonstrating MS1819s effect in reducing the conditions associated with chronic pancreatitis and improving the lives of EPI patients. We are excited to play an instrumental role in helping to develop new therapies for a range of human conditions said Dr. Richard Stubbs, Managing Director of P3 Research, in Wellington, New Zealand. We are committed to being a leader in trialling medicines that have significant potential to change patient care. MS1819-SD, an oral non-systemic biologic capsule, is a recombinant enzyme that is derived from the yarrowica lipolytica lipase, and is entirely plant-based/vegan.
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