After successfully proving efficacy to the Food and Drug Administration as well as European authorities, DBV Technologies plans to move ahead with Phase 3 trials for its Viaskin Peanut allergen patch product.
“We are very pleased with the outcome of our regulatory discussions with the EMA and the FDA, and we are thankful for both Agencies’ desire to move forward the development of what may be the first in class treatment for patients suffering from peanut allergy,” said Dr. Pierre-Henri Benhamou, Chairman and CEO of DBV.
Anticipated Phase III trial will test efficacy and safety in children aged 4-11 years.
The company is currently completing their Phase III testing protocols for submission to the FDA in order to begin clinical trials. They anticipate that this will happen late this year. The company plans to conduct the trials in several countries in order to win approval in multiple markets. Separate trials will also be conducted for younger and older patients upon approvals.
The Viaskin Peanut product is a skin patch, similar to a nicotine patch, which gives measured, controlled doses of the peanut proteins related to allergies. Over time, most patients develop a tolerance for higher levels of peanut allergen. The patch is hoped to be an alternative to traditional outpatient immunotherapy, which requires office visits and high associated costs.
Viaskin is one of several biotechnology companies researching allergy treatments utilizing a similar approach. Other solutions include sublingual drops, pills, and food additives.