French biopharma company DBV Technologies released their Q3 results yesterday, and the news is not good for those hoping for FDA approval of their Viaskin Peanut therapy any time soon.
Viaskin is the company’s immunotherapy platform that aims to desensitize a patient with a food allergy by introducing small quantities of allergen via the skin.
Viaskin Peanut, the first Viaskin candidate submitted for consideration to the US Food and Drug Administration, is aimed at children 4-11 years of age coping allergic to peanuts. The company also has therapies for milk and eggs in its pipeline.
The treatment, which utilizes Epicutaneous Immunotherapy (EPIT), consists of a series of quarter-sized patches that are worn by the patient, providing a steadily increasing dose of the allergen.
Back in August of 2020, the FDA denied Viaskin’s Investigational New Drug Application (IND) citing concerns that adhesion of the patch would affect the efficacy of the therapy, indicated the need for modifications and a new human factor study. The FDA also indicated that supplementary clinical data would need to be generated to support the modified patch and requested additional Chemistry, Manufacturing and Controls (CMC) data as well.
In their quarterly report, DBV provided more insight into the approval process with regard to STAMP, their protocol to test their modified patch:
The FDA has requested a stepwise approach to DBV’s modified Viaskin Peanut (mVP) development program. The FDA would like to review the data from DBV’s protein uptake release study prior to providing additional comments on the STAMP protocol design.
In its communication, FDA stated that guidance is forthcoming on how best to demonstrate the protein uptake comparability of the mVP to the reference or current patch (cVP).
The STAMP trial will not be initiated until DBV receives complete feedback from the FDA.
That means further delays before trials of the modified patch can even begin.
Said Daniel Tassé, CEO of DBV:
DBV is working hard to find an efficient and timely path forward. On behalf of patients and providers urgently awaiting a therapeutic advancement in treating peanut allergy, DBV will continue to pursue our goal of bringing Viaskin Peanut to the food allergy community.
Meanwhile, the European approval process for Viaskin Peanut is on track according to the company, which hopes to receive approval from the European Medicines Agency in 2022Q1.
As US approval delays mount, DBV is facing competition from another entrant into the EPIT market. Moonlight Therapeutics, a biotechnology company developing treatments for food allergies based on an immunotherapy patch utilizing microneedles, announced a $1.9 million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The grant will enable the company to complete its pre-clinical activities and submit an Investigational New Drug Application for the peanut allergy treatment with the FDA.