- Early data from the first EPI patients enrolled in clinical studies utilizing AzurRx’s MS1819 therapy shows positive results
- Data indicates that MS1819, a recombinant lipase derived from the yeast Yarrowia Lipolytica, is showing a favorable safety profile and encouraging signs of efficacy and drug tolerance
- The study is being performed at four sites in Australia and New Zealand
New York-based AzurRx BioPharma Inc. (NASDAQ: AZRX) is a biopharmaceutical company focused on the development of recombinant protein therapies for the treatment of gastrointestinal diseases and microbiome-related conditions. Patients with exocrine pancreatic insufficiency (EPI) related to chronic pancreatitis and cystic fibrosis are the focus of the company’s clinical trials now underway.
Yesterday, the company announced it has reached the 6th patient enrollment point in the ongoing 12-15 patient open-label phase IIa trial of MS1819. Results from the first six EPI patients enrolled in the study are slated to be released in September.
“We are pleased to reach this point in enrollment of this important clinical trial,” Thijs Spoor, CEO of AzurRx BioPharma, Inc., stated in a news release.
There are approximately 100,000 patients in the U.S. with EPI caused by chronic pancreatitis, according to the National Pancreas Foundation, with another estimated 30,000 patients with EPI caused by cystic fibrosis, the Cystic Fibrosis Foundation reports. When the pancreas can’t properly break down foods, poor digestion and malnutrition are the results. Patients with this condition are currently treated with porcine (derived from pig) pancreatic enzyme replacement pills.
The National Institutes of Health, analysts on Wall Street and the National Pancreas Foundation estimate the yearly market for pancreatic enzyme replacement therapy to be well over $800 million in the U.S. and at least $1.5 billion globally.
For more information, visit the company’s website at www.AzurRx.com
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