Teva Pharmaceuticals said on Wednesday that its experimental treatment for the disease is showing positive results. In a trial, adults with the disease were meaningfully protected from harm caused by gluten.
Celiac disease is an autoimmune disease affecting about one in every hundred people, damaging the small intestine when the sufferer is exposed to gluten. Currently, the only accepted treatment for the disease is a gluten-free diet.
The Israeli pharmaceutical giant, whose stocks rose about 2 percent after the announcement, is running a trial for its new antibody, “TEV ‘408.” In the trial, it gave the antibody to 50 gluten-free celiac adults, and two weeks later, they began a daily gluten challenge for six weeks.
At the end of the eight weeks, the trial reported statistically significant and clinically meaningful prevention of gluten-induced damage. In a statement, the company said that the antibody “was well-tolerated, with no safety signals observed to date.”
In a call with Wall Street analysts, Teva CEO Richard Francis said the company has no intention of developing the drug with partners.
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Analysts were interested in the differences between Teva’s trial and those of competing developments, in which higher doses of gluten were given to trial participants. Teva explained that it was important to give participants gluten doses they could tolerate, or else they might drop out of the trial.
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In the next phase of the study, which is meant to provide sufficient data to the U.S. Food and Drug Administration (FDA) for approval, Teva expects it will need to give participants more gluten per day in a longer trial.
In July, Teva announced successful results in a trial for an experimental drug that treats the skin condition vitiligo.