Dive Brief:
- DBV Technologies shares soared Wednesday after the company said its Viaskin peanut allergy patch succeeded in a Phase 3 trial.
- The results represent a comeback for the patch, which was rejected by the Food and Drug Administration in August 2020. At the time, regulators said the patch needed modifications to fully adhere to the skin and called for more data to support its efficacy.
- With the results of the trial, dubbed Vitesse, in hand, DBV now plans to submit an application to the FDA in the first half of next year to clear the patch for children between the ages of 4 and 7. The FDA has previously awarded the treatment a breakthrough therapy designation, and it may qualify for a priority review, DBV said Tuesday.
Dive Insight:
DBV has persevered through a number of setbacks for its peanut allergy patch. The French biotech’s shares plunged in 2017 after a study of Viaskin fell just short of its main goal. The company then plowed ahead with an FDA application, only to withdraw it in late 2018 after discussions with regulators on manufacturing and quality controls. DBV then tried again and failed in 2020.
In late 2021, DBV announced plans for a new Phase 3 clinical trial to address the FDA’s concerns. The company weathered a temporary partial clinical hold on the study in 2022 and last year, released its plans for pursuing approvals in the U.S. and Europe for children between the ages of 1 and 7. Earlier this year, DBV announced a financing of as much as $307 million to support the development.
Viaskin works by delivering a small amount of peanut antigen through the skin. The idea is to “re-educate” the immune system, desensitizing it to peanuts and allowing for greater exposure without the potentially debilitating effects that can accompany an allergy.
Vitesse is the largest study ever conducted of an immunotherapy for a food allergy, DBV said. It included 654 children who received either the active treatment or a placebo. Researchers then tested how much exposure to peanuts the children could take before an allergic reaction. After 12 months, about 47% of patients in the Viaskin group met the response criteria, compared with 15% in the placebo arm.
The most common side effects in the study were mild-to-moderate skin reactions to the patch, DBV said. Two children experienced treatment-related anaphylaxis and both continued with the therapy. Overall, there were no serious adverse events related to the treatment, the company said.
Palforzia, developed by Aimmune Therapeutics, became the first FDA-approved peanut allergy treatment in January 2020. But the COVID-19 pandemic, concerns about allergic reactions and the requirements for dosing hampered its uptake. Nestlé Health Science scooped up Aimmune in August 2020 believing it could boost the therapy, then sold Palforzia to Stallergenes Greer three years later.
Stallergenes Greer continued to develop Palforzia, winning approvals in the U.S. and Europe for treatment of children between the ages of 1 and 3. However, a notice on the drug’s website states that the company will discontinue Palforzia as of July 31, 2026. A spokeswoman for Stallergenes Greer didn’t immediately return a request for comment by email from BioPharma Dive.
DBV’s American depositary receipts spiked at more than $25 early Wednesday, a marked increase after trading below $3 late last year.
