May 11, 2011 — ImmusanT Inc., a privately held biotechnology start-up that's focusing initially on a treatment for celiac disease, says its Phase 1 study involving a potential vaccine for celiac shows promising results.
The study results, revealed at the Digestive Diseases Week conference, indicate that the vaccine, Nexvax2, is well tolerated and seems to have the right biological activity to help desensitize peoples' immune systems to the toxic effects of gluten, according to ImmusanT.
ImmusanT tested the potential vaccine in 34 healthy adults with confirmed celiac disease who follow a strict gluten-free diet and who carry the so-called celiac disease gene HLA DQ2, but not the less-common celiac gene HLA-DQ8. Participants received small, medium or large doses of Nexvax2 or a placebo once a week for three weeks.
The study found that the Nexvax2 vaccine was well-tolerated, although people who received larger doses experienced problems more often with nausea and vomiting; seven of the 19 subjects receiving medium and large doses of the vaccine reported nausea, including two who took anti-emetics and two who vomited after the first dose, and one subject receiving the largest possible dose of the vaccine withdrew from the study because of severe gastrointestinal symptoms.
However, Nexvax2 didn't appear to cause abdominal pain, diarrhea or abnormal bowel movements, since the incidence of those potential side effects was similar between the vaccine-treated and placebo groups, the study said.
Specific immune system activity related to the Nexvax2 vaccine was detected in four of the study subjects, indicating that the treatment can elicit the type of immune system response that ImmusanT believes ultimately may treat celiac disease.
ImmusanT expects to advance the potential celiac vaccine to a Phase 2a clinical trial in the next 10 months, said company chief scientific and medical officer Dr. Bob Anderson in a statement, adding, "we hope to demonstrate a dramatic reduction of the body's rejection of dietary gluten so patients can resume a normal diet and return to good health."
At the Digestive Diseases Week conference, Dr. Anderson and collaborating researchers also presented results from the first population-based study that supports the use of a combination of genetic tests and celiac blood tests to determine the prevalence of celiac disease.
Right now, celiac disease is diagnosed through a biopsy showing damage to the small intestine. However, biopsies are expensive and invasive, and researchers are examining whether accurate diagnoses can be made through alternative testing.
Dr. Anderson's study concluded that the cost per diagnosis could be reduced by up to 50% by introducing genetic tests to reduce biopsies, making celiac disease diagnosis more cost-effective and efficient. ImmusanT is collaborating with INOVA Diagnostics to develop improved serologic tests for celiac disease, and also is working to develop its own diagnostic tools.