Anthera Pharmaceuticals announced that the RESULT Phase 3 clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis has been approved by the European Cystic Fibrosis Society Clinical Trial Network (ECFS CTN) Executive Committee.
The aim of the ECFS CTN is to intensify clinical research in the area of cystic fibrosis and to bring new medicines to patients as quickly as possible. Enrollment in RESULT, in both the US and EU, is on schedule and inclusion of the study in the ECFS CTN may further expedite patient recruitment for the RESULT clinical study. Topline data are expected at the end of 2017 to early 2018, depending on the speed of patient enrollment.
"We are very pleased to receive approval by the ECFS Executive Committee for inclusion of the RESULT trial in the ECFS CTN,” said Craig Thompson, President & CEO of Anthera. “This achievement, in combination with the earlier approval from the Cystic Fibrosis Foundation Therapeutics Development Network, represents another key milestone for the RESULT trial.”
The RESULT clinical study design evolved from the data in 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 dose increases on an individualized basis to achieve maximum therapeutic benefit, while maintaining a potential reduction in daily pill burden due to Sollpura’s significantly more compact formulation technology.
