Anthera starts Phase III RESULT trial of Sollpura

Anthera Pharmaceuticals Inc. (NASDAQ:ANTH) began the Phase III RESULT trial to evaluate oral Sollpura liprotamase (LY3031642) for 4 weeks to treat exocrine pancreatic insufficiency due to cystic fibrosis (CF). Top-line data from the trial are expected by year end 2017 or early 2018.

The open-label, U.S. trial will enroll about 150 patients ages ≥7 who are well controlled on stable porcine-derived pancreatic enzyme replacement therapy (PERT). The primary endpoint will assess whether Sollpura is non-inferior to an approved porcine-derived PERT on the change from baseline in coefficient of fat absorption (CFA). Secondary endpoints will measure coefficient of nitrogen absorption and safety. Patients will be allowed to increase their daily dose of Sollpura to an individualized dose. Anthera said RESULT allows for more frequent and higher dose adjustments based upon clinical signs and symptoms than the previous Phase III SOLUTION trial of Sollpura (see BioCentury, Jan. 9). RESULT includes a 20-week extension period for patients randomized to the Sollpura arm...