Oct 20 (Reuters) - Drug developer DBV Technologies SA said on Friday its peanut allergy treatment did not meet the main goal in a highly anticipated late-stage study.
The trial, which tested a 250 microgram stick-on patch called Viaskin Peanut, in 356 children between the ages of 4-11, missed the main goal of achieving a certain tolerance to peanut protein. (bit.ly/2xbQD5H)
Preliminary results show 12 months of the treatment resulted in 35.3 percent of patients achieving a certain tolerance, versus a higher-than-expected 13.6 percent response from a placebo group.
However, DBV said the results showed a statistically significant response with a favorable tolerability profile.
Plans to submit a marketing application for the patch to the U.S. Food and Drug Administration (FDA) next year remain unchanged, the French drug developer said.
There are currently no U.S. regulator-approved treatments for peanut allergies, the leading cause of death from food-induced allergic reactions in the United States.
The market is desperate for recourse, experts say, as peanut allergies have more than doubled in children from 1997 to 2008, and affect about two percent American children.
Those afflicted risk potentially fatal anaphylaxis, a severe allergic reaction, even if exposed to trace amounts of peanut protein.
Viaskin Peanut, which must be replaced daily, delivers peanut protein to patients’ immune systems via the skin, desensitizing them to small doses of the allergen over time.
Unlike an oral drug, the patch avoids contact with the blood stream, lessening the risk of adverse reactions, DBV told Reuters.
Aimmune Therapeutics Inc, which is developing an oral peanut allergy pill, is expected to announce results of its late-stage trial early next year. (Reporting by Tamara Mathias in Bengaluru; Editing by Shounak Dasgupta)