AzurRx BioPharma shares rise after positive result in test to treat chronic pancreatitis

AzurRx BioPharma Inc (NASDAQ:AZRX) stock climbed on Monday after announcing along with European pharma company Mayoly Spindler that it has reached the primary and secondary endpoints in its Phase 2a trial to treat exocrine pancreatic insufficiency caused by chronic pancreatitis, a disease that mainly results from heavy drinking.

The Phase 2a study’s primary endpoint was to evaluate the safety of escalating doses of MS1819-SD in patients with chronic pancreatitis. The secondary endpoint for the study was to investigate the efficacy of MS1819-SD in these patients by analysis of any change from the baseline. 

Shares of the New York-based company were up 17% to $3.10 at the start of trade following the news. They rose 26.42% in the premarket to trade at $3.35, having closed on Friday up 6% at $2.65.

A total of 11 chronic pancreatitis patients were enrolled in France, Australia and New Zealand. During the course of the trial, patients “washed-out” of their standard of care treatment for EPI to establish a baseline and then were subsequently treated with escalating doses of the study drug in two-week increments.

Final data from the Phase 2a study show a favorable safety profile with no severe adverse events, a statement said.

READ: AzurRx BioPharma reports positive results in its Phase 2a trial of pancreatitis drug

Exocrine Pancreatic Insufficiency (EPI) is a condition characterized by a deficiency of the exocrine pancreatic enzymes, resulting in the inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss.

“The statistically significant improvement of MS1819-SD on CFA in patients with chronic pancreatitis is very encouraging,” said Doctor James Pennington, the chief medical officer of AzurRx.  “We look forward to initiating our Phase 2b trial of MS1819-SD in cystic fibrosis patients later this year.”

Favorable trends were also observed on other evaluated endpoints, including the Bristol stool scale, number of daily evacuations and stool weight, which were consistent with the CFA results.

“We are very pleased that the Phase 2a data show a statistically significant improvement in CFA of 21.8% at the highest dose, which compares quite favorably with historical data for the currently available porcine agents in patients with chronic pancreatitis1,” said Thijs Spoor, the CEO of AzurRx. “These results support our confidence in the next phase of MS1819’s clinical development as a new therapy for patients suffering from cystic fibrosis.”

AzurRx BioPharma is engaged in the research and development of non-systemic biologics for the treatment of patients with gastrointestinal disorders. The company is based in Brooklyn, New York.

Story by ProactiveInvestors