Nexvax2 is being developed to protect celiac disease (CeD) patients who carry the HLA-DQ2.5 immune recognition genes, from inadvertent gluten exposure.
This vaccine will be administered subcutaneously.
Patients with the HLA-DQ2.5 genes account for more than 90% of the CeD population.
Update June 25, 2019:
ImmusanT, Inc. has discontinued the Phase 2 global study for Nexvax2, intended as a treatment for celiac disease.
The results from an interim analysis revealed Nexvax2 did not provide statistically meaningful protection from gluten exposure for celiac 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.
Clinical Trial NCT03644069: A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
- A phase 2, randomized, double-blind, placebo-controlled clinical study of Nexvax2, in adult subjects with confirmed CeD who have been following a gluten-free diet for at least 12 consecutive months prior to screening.
- This study will evaluate the efficacy of Nexvax2 administered subcutaneously.
- The study plan consists of 3 periods: a screening period of 6 weeks, an approximately 16 week treatment period, and a 4-week post-treatment observational follow-up.