Posted by Michael Wonder on 03 Jan 2019
ImmusanT secures fast track designation for lead therapeutic vaccine candidate Nexvax2 for patients with celiac disease
2 January 2019 - Nexvax2 has been designed to potentially restore immune tolerance to gluten in patients with celiac disease.
ImmusanT announced today the U.S. FDA has granted fast track designation to the company’s lead therapeutic candidate, Nexvax2, being developed to protect celiac disease (CeD) patients who carry the HLA-DQ2.5 immune recognition genes, from inadvertent gluten exposure. Patients with the HLA-DQ2.5 genes account for more than 90% of the CeD population. A global Phase 2 study assessing Nexvax2 is currently recruiting patients.
ImmusanT’s Phase 2 RESET trial is a randomised, double-blind, placebo-controlled study in HLA- DQ2.5+ adults with CeD to assess the effect of Nexvax2 on symptoms after masked gluten food challenge. The trial intends to enrol approximately 150 patients across the U.S., Australia and New Zealand.
