- Encouraging results noted for pancreatitis patients with exocrine pancreatic insufficiency
- Early data shows favorable safety profile, positive dose tolerance
- Favorable trends observed in other identified markers
- Study is being performed at four sites in Australia and New Zealand
New York-based AzurRx BioPharma Inc. (NASDAQ: AZRX), a biopharmaceutical company engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders, recently announced positive results from its ongoing clinical trials of MS1819-SD, a recombinant lipase, developed for the treatment of exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis.
In an update issued last week (http://dtn.fm/njK0J), AzurRx BioPharma said clinical trials of the first six patients being treated with MS1819-SD underway in Australia and New Zealand are showing encouraging results. Importantly, the company said patients showed a positive dose response curve and a 21% improvement in the coefficient of fat absorption in evaluable patients. The response rate went as high as 57% in one of the patients, and higher response rates were noted in patients with lower baseline CFA levels. Favorable trends were also observed in other endpoints with no serious adverse events reported.
“We are encouraged by these Phase IIa data,” Thijs Spoor, CEO of AzurRx BioPharma, stated in the news release. “They further confirm the activity of MS1819-SD and also demonstrate its dose response characteristics. Additionally, secondary efficacy endpoints are consistently aligning with the CFA data and the safety profile of MS1819-SD remains favorable.”
The primary objective of the phase IIa study is to investigate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary objective is to investigate the efficacy of MS1819-SD in these patients by analysis of the coefficient of fat absorption and its change from baseline. Patient safety is of paramount importance and is assessed at the end of each treatment period, with attention being paid to immunoallergic effects, digestive symptoms and clinical laboratory results.
AzurRx Biopharma expects to enroll 12-15 patients in this open-label phase IIa trial of MS1819-SD, which is being conducted in partnership with Mayoly Spindler, a European pharmaceutical company. 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 is the result. 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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