ImmusanT cans phase 2 celiac trial after interim efficacy review

stopsign
ImmusanT saw celiac disease as a good proving ground for its approach. (Pixabay)

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.

Webinar

Lipid-based Formulations for Early Stage Clinical Trials

Liquid-filled capsule technology has a proven record for addressing complex API formulation challenges, but also offers a simple and effective pathway to the clinic. Register now to learn more about lipid-based formulations.

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.

Suggested Articles

A new clinical hold is the latest setback for Solid Biosciences and the development of its gene therapy for Duchenne muscular dystrophy.

VBI's Sci-B-Vac protected twice as many people than GSK's Engerix-B did after the second dose.

The notice comes weeks after Amgen revealed it was retreating from its East Coast neuroscience operations.