Children in the phase 3 Pepites clinical trial were able to continue on the drug in an extension study called People. After three years of treatment, 75.9% of patients had increased their eliciting dose (ED) -- the amount of peanut protein a patient can take before having an allergic reaction -- and 51.8% of patients reached an ED of at least 1,000 mg peanut protein. Only 40.4% of the patients had reached that threshold after 12 months, suggesting that longer doses can help some patients gain greater immunity.
DBV Technologies also reported some data suggesting the drug has a lasting effect. Patients who reached the 1,000 mg threshold were taken off of Viaskin Peanut and retested two months later, when 77.8% of the 18 children continued to tolerate 1,000 mg of peanut protein.
The safety of the treatment is as important as its long-term efficacy given that Aimmune Therapeutics (NASDAQ:AIMT) has had some issues with reactions to its competing peanut allergy treatment AR101, where 14% of patients had to use epinephrine to treat an adverse event. DBV said the "safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients" and noted that one patient had a mild anaphylactic reaction that resolved without treatment.
The long-term data should help increase sales of Viaskin Peanut, but DBV Technologies first has to get the drug approved by regulators. The Food and Drug Administration accepted the marketing application in August 2019, following the withdrawal of the company's first application in December 2018 because it was missing some data on the manufacturing of the compound and some quality controls.
The FDA's acceptance of the application implies that DBV Technologies took care of the issues, but investors won't know for sure until the agency makes its final decision, which is expected on or before Aug. 5, 2020.