US based biotechnology company ImmusanT Inc. has announced it will discontinue its international Phase 2 clinical trials of Nexvax2®, a therapeutic vaccine for coeliac disease.
ImmusanT has reported that the results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for coeliac disease patients when compared with placebo.
Similar to earlier Phase 1 results, Nexvax2 was found to be safe and generally well tolerated. There were no concerning safety issues identified during the study.
ImmusanT will be actively investigating data gathered from the trial to further understand this outcome. The company will provide further information once available.
About the Trial
The ‘RESET CeD’ trial was designed to test the safety, tolerability and efficacy of the vaccine in adults with coeliac disease who have the common HLA-DQ2.5 gene seen in approximately 90% of people with coeliac disease.
Nexvax2 was administered as a series of injections designed to target and reprogram the T cells that trigger an inflammatory response to gluten. By suppressing inflammation, the therapy was aiming to prevent the adverse symptoms caused by gluten ingestion in people with coeliac disease.
In prior Phase 1 studies, Nexvax2 was shown to be safe and well-tolerated when administered at its highest dose levels.
On behalf of Wesley Medical Research, we want to express our sincere appreciation to all patients that participated in the RESET CeD clinical trial.
Their important contributions have helped significantly advance the global understanding of coeliac disease and the science underlying this condition.
While on this occasion, the trial did not achieve the desired outcome, we believe the study will generate valuable data that will help inform the field on improving treatment for patients with coeliac disease.
We encourage people who suffer with coeliac disease to remain hopeful and engaged in coeliac disease research.
To learn more about this outcome – read the ImmusanT Inc. media release here