Aimmune and DBV Eye the Finish Line for Peanut Allergy Treatments
An estimated 15 million people in the United States have allergies to more than 170 different foods, according to the non-profit Food Allergy Research and Education. New health data suggests the frequency of food allergies in children under 18 has risen 70 percent since 1997, CNBC reported.
With the rise in food allergies, there are a number of biopharma companies driving forward with medications that can help people augment their immune systems to avoid or minimize allergic reactions to certain foods. This year several companies are expected to file for regulatory approval of medications aimed at addressing these issues, particularly peanut allergies. There are currently no approved treatments for peanut allergies, which is the leading cause of food-induced allergic death in the United States.
By the end of the year, Brisbane, Calif.-based Aimmune intends to file a Biologics License Application for its peanut allergy treatment, AR101. Aimmune’s AR101 is an oral biologic desensitization therapy that is sprinkled over food before eating. In February, Aimmune released Phase III trial data that showed its peanut allergy therapy was effective in more than 67 percent of juvenile patients. Aimmune said 67.2 percent of juveniles ages four to 17 who were administered AR101 in the Palisade trial could tolerate exposure of at least a 600-mg dose of peanut protein in the exit food challenge. Only 4 percent of patients on the placebo could tolerate that amount, the company said.
This morning, CNBC noted that if Aimmune’s therapy is approved by the FDA, the company could see peak sales of $1.3 billion by 2025.
Days after Aimmune announced its positive late-stage peanut allergy data, French company DBV Technologies announced it saw positive outcomes from its milk allergy trial. Milk allergies are among the most common in children, affecting between 2 to 3 percent of the population. Reactions can range from mild to severe.
The mid-stage trial showed that DBV Technology’s Viaskin Milk product yielded successful results in patients suffering from IgE-mediated cow's milk protein allergy. Data showed that children on DBV’s Viaskin treatment had a statistically significant desensitization to milk after 12 months of treatment. Viaskin is an electrostatic patch, based on Epicutaneous Immunotherapy, which administers an allergen directly onto the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.
Last year DBV reported its Phase III peanut allergy trial failed to show a statistically significant response against placebo. However, in February, the company received permission to seek approval from the FDA, despite the Phase III problems. At the time, Bloomberg reported the FDA “agreed that the available efficacy and safety data” supports the submission of an application that, if approved, would let DBV bring its Viaskin patch to market.
In addition to Aimmune and DBV, pharma giants Regeneron and Sanofi are also eying treatments for peanut allergies. The companies are working with their IL-4 and IL-13 inhibitor Dupixent as a potential treatment for the allergy. Last year perennial development partners Sanofi and Regeneron teamed up with Aimmune to pair AR101 with Dupixent