Anthera screens first patient in pivotal Sollpura study
Wednesday, May 17, 2017
Anthera Pharmaceuticals has commenced screening in the RESULT phase III clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis. Based on feedback from the FDA, this non-inferiority study will compare the efficacy of Sollpura, a biologically manufactured pancreatic enzyme replacement therapy (PERT), to Pancreaze, a porcine-extracted PERT, as assessed by CFA after four weeks of treatment. Topline data are expected at the end of 2017 or early 2018, depending on the speed of patient enrollment.
“As a key investigator in the SOLUTION study and now participating in the RESULT study, I am excited to be part of this important study for Cystic Fibrosis patients with exocrine pancreatic insufficiency. Sollpura has the potential to address an unmet need for PERTs with a reduction in pill burden, as well as the benefit of a product that is not extracted from pigs,” shared Dr. Steven R. Boas, M.D., FAAP, FACSM president and CEO, The Cystic Fibrosis Institute, Glenview, IL.
The RESULT clinical study builds upon data from the previous Sollpura trial (SOLUTION) and allows for more frequent and higher dose adjustments based upon clinical signs and symptoms. As with current practice with porcine enzymes, the RESULT study allows patients to increase their daily dose to an individualized dose that achieves maximum therapeutic benefit, while maintaining a potential reduction in daily pill burden as compared to porcine PERTs.
“We are very pleased to achieve this important milestone for Sollpura,” shared William Shanahan, chief medical officer, “and we appreciate the input from the US FDA and members of the CF Community in the design of RESULT. There is enthusiasm within patient and provider communities for a non-porcine derived product and we look forward to this important study.”
The phase III RESULT study is designed to evaluate the non-inferiority of Sollpura at individualized doses compared to approved, porcine-derived, enteric-coated PERT when administered to patients with exocrine pancreatic insufficiency due to cystic fibrosis. The study will enroll patients (N˜150) with exocrine pancreatic insufficiency due to cystic fibrosis who are well controlled on stable porcine PERT at screening, as demonstrated by a minimum CFA. The primary efficacy variable will evaluate the change from baseline in CFA following four weeks of treatment with either Sollpura or Pancreaze. Patients randomized to Sollpura will then be followed for an additional 20-Week extension period (total of 24 weeks on study) for additional assessments of weight, height, BMI, and safety.