DBV Technologies will be making another attempt at gaining US Food and Drug Administration (FDA) approval for its peanut allergy patch following new Phase III data.
In the VITESSE trial (NCT05741476), which enrolled 654 children aged between four and seven years old, the VIASKIN Peanut patch demonstrated a statistically significant treatment effect, with 46.6% of children in the VIASKIN Peanut arm tolerating exposure to peanut protein after 12 months, compared to 14.8% of children in the placebo arm.
Responders were defined as children with a baseline eliciting dose (ED) of less than 30mg who achieved an ED of more than 300mg of peanut protein, or a child with a baseline ED of 100mg who achieved an ED of more than 600mg of peanut protein after 12 months of treatment. ED is the amount of peanut protein that induced an allergic reaction.
Despite having made changes to the patch based on a complete response letter (CRL) from the FDA in 2020, safety results remained consistent with previous studies of the patch, with the most common treatment-emergent adverse events (TEAEs) being mild-to-moderate local skin reactions at the patch application site. Treatment-related anaphylaxis occurred in two children, but both were able to continue treatment.
Dr David Fleischer, professor of paediatrics at Children’s Hospital Colorado and principal investigator of the VITESSE study, said: “The levels of desensitisation achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into paediatric care.”
After the data announcement, DBV’s stock rose by 42.99%, from a €3.07 ($3.60) close on 16 December to a €4.39 open on 17 December. The French company has a market cap of €803.7m.
Based on this study, DBV is moving forward with plans for a biologics licence application (BLA) submission to the FDA in the first half of 2026.
This will mark the third attempt by DBV to gain approval of its patch. The first was actually withdrawn by DBV in December 2018 after it discovered issues with manufacturing and quality control in its submission. This previous attempt was made despite the Phase III PEPTITES trial failing to meet its primary endpoint.
The company resubmitted but was issued a CRL in August 2020 due to efficacy concerns related to patch adhesion issues. As a result, the company redesigned the patch before conducting the VITESSE trial.
Also in 2020, the FDA approved the first drug for peanut allergy – Stallergenes Greer’s Palforzia. The drug was developed by Aimmune Therapeutics before being acquired by Nestlé in August 2020. Stallergenes Greer took ownership of the candidate in September 2023; however, it has since announced that it will discontinue commercialisation of the drug in July 2026.
GlobalData valued the global food allergy market at $213.8m in 2020, and forecasts it will be worth $2.7bn by 2030 at a compound annual growth rate (CAGR) of 28.8%.
GlobalData is the parent company of Clinical Trials Arena.
