Nexvax2 trial discontinued

Vaccine provided no more protection than placebo

By Amy Ratner, Medical and Science News Analyst

A clinical trial investigating Nexvax2 has been discontinued due to results that showed the vaccine to treat celiac disease did not provide protection from gluten exposure when compared to a placebo.

ImmunsanT announced its decision to end the RESET CeD trial Tuesday in a message to patients who participated in the study. About 150 patients had been enrolled from across the United States, Australia and New Zealand with the first patient beginning the trial last September.

An interim analysis of the Phase 2 study revealed the lack of statistically meaningful protection from gluten exposure compared to a placebo, according to ImmusanT.

“As such, the company has made the difficult decision to discontinue the RESET CeD study,” ImmusanT said. “While we did not achieve the desired outcome, we believe the study will generate valuable data that will help inform the field on improving treatment for patients with celiac disease.”

When the trial started, Ken Truitt, MD, chief medical officer of ImmusanT, said it would be “important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet.” He said the company anticipated that the study would provide “new insights that will further our ability to demonstrate specific suppression of the immune response to gluten epitopes and associated effects of celiac disease.”

The announcement of the discontinuation of the RESET CeD trial comes on the heels of encouraging results of a separate Phase 1 study presented at the recent Digestive Disease Week indicating Nexvax2 induced tolerance of even high doses of gluten peptides in celiac disease patients.

The smaller, seven-week study described at DDW involved 12 patients and was done to compare the effectiveness of subcutaneous injection of the vaccine to intradermal injection.

Nexvax2 is designed to target the cells that react to gluten and turn off the response in the 90 percent of celiac disease patients who have the HLA-DQ2.5 gene.

Nexvax2 is one of several celiac disease drugs that had reached Phase 2 clinical trials. ImmusanT noted that the RESET CeD study found that the vaccine was safe and generally well tolerated. Phase 2 trials involve more study participants and are conducted for a longer period of time. Nearly 70 percent of drugs that reach this phase fail, according the U.S. Food and Drug Administration.

The company has not commented on the future of Nexvax2 but will investigate the trial to further understand the outcome. The company will provide further information once available, said Leslie Williams, ImmusanT president and CEO.