ImmusanT cans phase 2 celiac trial after interim efficacy review

ImmusanT has stopped a phase 2 trial of its lead candidate in celiac disease after an interim analysis. The analysis found Nexvax2 was no better than placebo at protecting patients from gluten exposure, prompting the Arch Venture Partners-backed biotech to stop the study.

Massachusetts-based ImmusanT tapped Arch and Vatera Healthcare Partners for $40 million in 2017 and embarked on a phase 2 trial designed to demonstrate the potential of Nexvax2 in the protection of people with celiac disease. The trial randomized 146 people to receive either therapeutic vaccine Nexvax2 or placebo and put them through food challenges containing gluten.

ImmusanT is yet to share data from the trial, but whatever researchers saw at the interim review was bad enough to convince them it would be futile to continue the study. The action suggests the vaccine was no better than placebo at reducing gastrointestinal symptoms associated with gluten.

In a brief statement, ImmusanT said the vaccine was safe and generally well tolerated and that it is now going over the data in an attempt to understand why the trial failed.

If the discontinuation marks the end of the line for Nexvax2, ImmusanT has little to fall back on. The only other publicly disclosed candidate in ImmusanT’s pipeline is a preclinical stage Type 1 diabetes vaccine. ImmusanT also has two earlier-stage candidates against undisclosed indications.

The celiac and diabetes vaccines are both based on the same technology, dubbed epitope-specific immunotherapy. The idea is to use peptides to target and modify T cells, thereby making the immune system tolerant of antigens at the heart of autoimmune diseases.

ImmusanT saw celiac disease as a good proving ground for the approach but has been knocked back by the failure of Nexvax2 to clear an early test of its efficacy.