Dr Robert P Anderson MBChB BMedSc PhD FRACP
Chief Scientific Officer
ImmusanT, Cambridge, MA
MedicalResearch.com: What is the background for this study?
Response: The 2 Phase 1 trials were randomized, double-blind, placebo-controlled, multi-center studies evaluating the safety, tolerability, and relevant bioactivity of Nexvax2 in HLA-DQ2.5+ patients with celiac disease. In one study, patients received three fixed doses of Nexvax2 or placebo once per week over a three-week period. In the other study, patients received 16 fixed doses of Nexvax2 or placebo twice per week over an eight-week period. Both studies evaluated a range of fixed, intradermal dose administrations in a series of ascending dose cohorts, which included a crossover, double-blind, placebo-controlled oral gluten challenge in the screening and post-treatment periods. The primary outcome measures were the number and percentage of adverse events in the treatment period.
MedicalResearch.com: What are the main findings?
Response: The studies met their primary endpoints and modifies the T cells reactive to gluten. After the first dose, some participants experienced nausea and vomiting, similar to symptoms observed following gluten ingestion in celiac disease. Later doses of Nexvax2 had clinical effects similar to placebo. The acute immune response stimulated by Nexvax2 after the first dose was similar to eating gluten, but was reduced and absent after later doses. There was no apparent difference between placebo and Nexvax2 in duodenal histology following twice-weekly dosing at the maximum tolerated dose for eight-weeks.
MedicalResearch.com: What should readers take away from your report?
Response: This is the first report of a therapeutic vaccine for celiac disease. This provides hope for those living with Celiac Disease.
The results demonstrate encouraging clinical and biologic effects for Nexvax2 consistent with its potential to protect against gluten exposure.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: In total, four Phase 1 clinical studies with Nexvax2 have supported the safety, tolerability and relevant bioactivity of Nexvax2 as an antigen-specific immunotherapy in celiac disease. This provides a strong basis for advancing the clinical development, Phase 2, of Nexvax2 which is the first therapeutic vaccine designed for patients with celiac disease on a gluten free diet.
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Epitope-specific immunotherapy targeting CD4-positive T cells in coeliac disease: two randomised, double-blind, placebo-controlled phase 1 studies
Goel, Gautam et al.
The Lancet Gastroenterology & Hepatology , Volume 0 , Issue 0 ,
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