ImmusanT completes phase 1b clinical trial of Nexvax2.
M2 EQUITYBITES-February 24, 2017-ImmusanT completes phase 1b clinical trial of Nexvax2
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ImmusanT, a clinical-stage company developing Nexvax2, has completed a phase 1b clinical trial assessing the safety and tolerability of Nexvax2 in celiac disease, it was reported yesterday.
The trial met its objectives and identified a Phase two dose regimen.
Nexvax2 is an epitope-specific immuno-therapy that consists of three immunodominant peptides, designed to protect against gluten exposure. The study was a randomised, double-blind, placebo-controlled, dose titration trial to assess the safety and tolerability of gradual dose escalation before increased maintenance doses of Nexvax2 in patients with celiac disease. The study enrolled 38 patients with celiac disease who were stratified by HLA-DQ2.5 genotype and randomly assigned to one of three cohorts. All cohorts were then randomised to escalating doses of intradermally-administered Nexvax2 or placebo followed by maintenance doses higher than those earlier tested for a period of 46 or 60 days.
The results of this clinical trial support a dosing regimen for a planned Phase two clinical trial of Nexvax2 in patients with celiac disease.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Feb 24, 2017|
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