AzurRx BioPharma has enrolled the sixth patient in a Phase 2 clinical trial of MS1819 as a treatment for a digestive disorder known as exocrine pancreatic insufficiency that is associated with cystic fibrosis.
The company hopes to enroll 12-15 patients in the study (ACTRN12616000962437), which it is conducting in Australia and New Zealand. To try to obtain the number of participants it wants, it recently added a trial site in Australia.
Exocrine pancreatic insufficiency, or EPI, makes it difficult to digest food. It involves the pancreas not making enough of the enzymes the body needs to break down and absorb nutrients.
“We are pleased to reach this point in enrollment of this important clinical trial,” Thijs Spoor, CEO of AzurRx BioPharma, said in a press release. “The additional clinical site in Australia is expected to drive enrollment in both this study and other future planned clinical trials. Following the positive interim data we reported in the second quarter on the first three patients in the Phase 2a study, we look forward to the availability of additional results from the first six patients in September.”
MS1819 is a recombinant lipase — or enzyme that helps break down fats — that is derived from the yeast Yarrowia Lipolytica. Researchers are looking at MS1819 as a potential replacement for the pancreatic lipase deficiency that is common in people with exocrine pancreatic insufficiency.
All of the trial participants will receive MS1819. The drug will be delivered in four escalating doses over 48-60 days, with patients participating a total of 74-93 days.
A Phase 1b study proved MS1819 to be safe. In a Phase 2a trial, the treatment led to a more than 20 percent increase in patients’ ability to absorb fat. The yardstick was their scores on a test called the coefficient of fat absorption.
MS1819 also proved safe in the Phase 2a study, with no moderate or severe adverse events.
AzurRx expects to report findings on the study’s first six patients in September 2017.
The Cystic Fibrosis Foundation reports that more than 30,000 Americans have exocrine pancreatic insufficiency due to CF. Patients receive pancreatic enzyme replacement pills derived from pigs to overcome their nutrient absorption problems. Pig-based drugs carry risks, however — so researchers are trying to develop new therapies.