AzurRX BioPharma Inc. (NASDAQ:AZRX) has announced the dosing of the first two patients in Turkey for the Phase 2 study. The study is evaluating MS1819, its experimental drug in combination with the existing standard of care therapy, porcine-derived pancreatic enzyme replacement therapy (PERT) in severe exocrine pancreatic insufficiency treatment in cystic fibrosis patients.
AzuRX doses first patients in Turkey
James Sapirtein, AzurRx CEO and President said that despite the challenges the pandemic presented the company is delighted to see the combination therapy study move to clinical trials in Turkey. He said that the company expects to release topline study data in Q2 2021. Sapirtein said that they are optimistic that the results will build on the positive results received at the beginning of this year. This will put the company a step closer to delivering a therapy that can improve the lives of several cystic fibrosis patients.
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Recently the company announced the activation of additional clinical sites in Turkey following Hungary as the second country where the company has doses patients in the Combination study. Currently, there are already five clinical sites activated in Turkey screening patients.
The second phase Combination Trial is evaluating the efficacy and safety of MS1819 given for 15 days in increasing doses of 700mg, 1,200mg, and 2,240mg daily in combination with PERT. According to previous study results, the combination therapy resulted in clinically significant improvements in five patients in the primary efficacy endpoint, coefficient of fat absorption as well as a significant improvement in secondary endpoints. The secondary endpoints include stool consistency, body weight, and the number of bowel movements reductions.
Combination therapy to solve the problem of fat absorption
Currently, the only commercially available digestive standard of care for chronic pancreatitis and CF patients with EPI are PERTs. Normally a stable PERT daily dose will allow patients to eat a high-fat diet and reduce gastrointestinal discomfort. However, in most cases, some CF patients do not achieve normal fat absorption with PERTs and this is where the MS1819 Combination Therapy will help. It will eliminate abdominal symptoms, correct micronutrient, and macronutrient maldigestion, and sustain optimal nutrition status.