Perspective

ImmusanT discontinues phase 2 trial of celiac disease vaccine

ImmusanT announced that it will discontinue its phase 2 global study of Nexvax2, a peptide-based immunomodulatory vaccine intended to treat celiac disease, according to a company press release.

Although Nexvax2 has been found to be safe and well-tolerated, an interim analysis demonstrated that the vaccine did not provide statistically meaningful protection from gluten exposure for patients with celiac disease compared with placebo.

When reached for comment, ImmusanT said that it “is continuing to compile and analyze information regarding the outcome of this study and will be providing an update accordingly.”

ImmusanT announced that it will discontinue its phase 2 global study of Nexvax2, a peptide-based immunomodulatory vaccine intended to treat celiac disease, according to a company press release.

Although Nexvax2 has been found to be safe and well-tolerated, an interim analysis demonstrated that the vaccine did not provide statistically meaningful protection from gluten exposure for patients with celiac disease compared with placebo.

When reached for comment, ImmusanT said that it “is continuing to compile and analyze information regarding the outcome of this study and will be providing an update accordingly.”

    Perspective
    Peter H.R. Green, MD

    Peter H.R. Green, MD

    It is a great shame that the vaccine did not appear to induce tolerance of gluten for the study participants. There was a lot of hope that this would work as an immunotherapy for celiac disease. It takes $1 billion and 10 years to get a drug on the market and there are a lot of different groups that are looking at different drug targets for celiac disease.

    Most early drugs fail in the beginning and that leads to better drugs later. It’s part of the process, and without smart ideas there wouldn’t be advances. ImmusanT likely has a lot of information that we can learn from.

    Several years ago, I participated in a double-blind, placebo, randomized trial in which a candidate drug for celiac disease was trialed, it didn’t work, and the company folded the day after the announcement of the study result. Now that drug has been repackaged and will be studied in a different population of people with celiac disease.

    It’s surprising when studies don’t work. But we will learn from each study. Modulating the immune system may be a potential therapeutic area. This first attempt in modulating the immune system didn’t appear to work so the researchers stopped the study. We’ll eventually see if anything can be resurrected with this drug and/or we will move on to different drugs.

    • Peter H.R. Green, MD, MD
    • Phyllis and Ivan Seidenberg Professor of Medicine
      Director, Celiac Disease Center
      Columbia University Medical Center

    Disclosures: Green reports serving on a scientific advisory board for ImmusanT.