DOR has announced that it has received Protocol Assistance feedback from the European Medicines Agency (EMEA) on the design of its confirmatory, pivotal, Phase-III clinical trial. The trial is meant to evaluate its lead product orBec, for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD).
EMEA agreed that should the new confirmatory Phase-III study produce positive results, the data would be sufficient to support a marketing authorization approval in all 27 EU member states. In doing so, EMEA agreed to the primary endpoint and other principal design features of the new study.
The EMEA’s response is consistent with feedback previously received from FDA, paving the way for potential approval in the US and EU.
Based on data from the prior Phase-III study of orBec, the upcoming confirmatory Phase-III clinical trial will be a highly powered, double-blind, randomized, placebo-controlled, multicenter trial.
Christopher Schaber, President and CEO of DOR, said: We are very pleased to obtain a positive response from the EMEA regarding the design of our upcoming confirmatory, pivotal Phase 3 study.
The depth and strength of our available Phase 3 data have allowed us to design and power a pivotal trial that we believe maximizes orBec’s chances for success. With our primary endpoint of the treatment failure rate at Study Day 80, we expect to replicate statistical significance in this clinically meaningful endpoint with orBec, he said.