Development of the world’s leading potential coeliac disease vaccine, Nexvax2®, has progressed, with the company ImmusanT Inc. initiating a Phase 2 study in people with coeliac disease living in Australia and New Zealand. The study aims to further assess safety, tolerability and efficacy of its proprietary peptide-based compound.
Administered subcutaneously, Nexvax2® is intended to reprogram T cells that trigger an inflammatory response to gluten, thereby suppressing inflammation in patients with coeliac disease. It has been in development for over a decade, and is currently the only disease-modifying therapeutic approach for coeliac disease in clinical development. ImmusanT Inc maintain it has the potential to enable patients to return to a normal diet.
In multiple Phase 1 trials, Nexvax2® was demonstrated to be safe and tolerable at therapeutically-relevant dose levels. The Phase 2 trial, RESET CeD, intends to enrol approximately 150 patients across the United States, Australia and New Zealand. In Australia, trials will start in Melbourne and then roll out in Perth, Adelaide, Brisbane, Mackay and the Sunshine Coast.
A factsheet published by ImmusanT provides additional information including an overview of coeliac disease and the way in which the Nexvax2® compound can offer protection for up to 80% of those with coeliac disease.
For more information about the RESET CeD trial, including details on how to participate, visit www.clinicaltrials.gov.