Phase 2 Trial of Celiac Disease Vaccine Cancelled by ImmusanT

ImmusanT, a company creating a vaccine therapy for patients with celiac disease, has discontinued the phase 2 global study for its lead vaccine candidate, Nexvax2, it announced on Wednesday.

“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,” a press release stated. 

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Similar to the results in phase 1 of the trial, Nexvax2 was found to be safe and generally well tolerated. According to ImmusanT, no safety issues were identified during the trial. The company will investigate data from the trial to further understand the outcome. 

Currently, there is no cure for celiac disease (following a strict gluten-free diet is the only treatment). Nexvax2 was the only disease-modifying approach for celiac in clinical development right now. The vaccine was designed to reprogram the T cells that are trigged by a person’s immune response to gluten.

Nexvax2 aimed to restore immune tolerance to gluten, reduce inflammation in the small intestine and ultimately, allow those with celiac disease to resume eating a diet with gluten in it. Phase 2 of this trial enrolled 150 patients in Australia, New Zealand and the U.S. Read Gluten-Free Living’s interview with one of those patients here. 

Phase 1 of the trial was considered successful, as the vaccine was shown to be safe and well-tolerated, even when given at its highest doses. The goal of phase 2 was to confirm the effectiveness of the vaccine and broaden ImmusanT’s understanding of the impact of immunotherapies.

ImmusanT also uses its platform to develop peptide-based immune therapies for people with other autoimmune diseases, including type 1 diabetes. The company also focuses on developing highly specific diagnostics and are developing their first diagnostic which diagnoses celiac disease through an in vitro blood test that measures T-cell markers.  

Click here for more information on celiac disease and its symptoms.

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