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AzurRx's shares dive as cystic fibrosis drug fails to match replacement therapy

AzurRx BioPharma Inc.'s experimental treatment MS1819 did not perform as well as enzyme replacement therapies during a mid-stage study in cystic fibrosis patients who cannot digest food properly.

The stock price of the Brooklyn, N.Y.-based company was down nearly 18% to 73 cents as of 12:47 p.m. ET on Sept. 25.

Cystic fibrosis is a genetic disorder that affects mostly the lungs but can also have an impact on the pancreas, liver, kidneys and intestines. In cystic fibrosis, the body produces thick and sticky mucus that clogs the organs and can be life-threatening. Patients can experience difficulty digesting food due to the deficiency of certain enzymes produced by the pancreas.

AzurRx compared a 2-gram daily dose of oral MS1819 with porcine pancreatic enzyme replacement therapies, or PERT, in 32 patients during the phase 2 trial called Option. Patients received either treatment for three weeks and were then crossed over to the alternative treatment arm for another three weeks.

The biotech company found that patients taking MS1819 did not absorb fat as well as the PERT treatments, but had similar results for nitrogen absorption.

AzurRx plans to meet with the U.S. Food and Drug Administration before the end of the year to discuss the design of a phase 2b/3 trial with higher doses of the drug, the company said in a Sept. 25 press release.

The company released final data from a phase 2a trial in September 2018 that showed MS1819-SD was safe and effective in patients with exocrine pancreatic insufficiency caused by chronic pancreatitis. About 90,000 patients in the U.S. have this disorder, caused by chronic pancreatitis, while more than 30,000 experience it because of cystic fibrosis, according to the company's release.