Viaskin Peanut (DBV712): Non-Invasive Epicutaneous Patch for Peanut Allergy – Regulatory Updates in the U.S. and EU

October 27, 2021 /BioonBIOON/ -- DBV Technologies is a clinical-stage biopharmaceutical company currently developing the Viaskin platform, a proprietary technology platform with broad potential applications in immunotherapy.Viaskin is based on epicutaneous immunotherapy (EPIT) and delivers bioactive compounds to the immune system through intact skin.. With this novel non-invasive product candidate, DBV Technologies is committed to safely transforming the care of patients with food allergies.

Currently, DBV is developingPeanut Allergy Patch Viaskin Peanut (DBV712), this product is a`Non-invasive, once-daily skin patch`, be able toGradually training the human immune system to develop tolerance to peanuts, for use in children aged 4 to 11 yearsTreatment of Peanut Allergy. In 2015, the United StatesFDAGranted for Viaskin Peanut for the Treatment of Peanut AllergyBreakthrough Therapy Designation (BTD)。

The Viaskin Peanut patch, developed using DBV Technologies' Viaskin platform, gradually trains the human immune system to develop tolerance to peanuts.Viaskin is an electrostatic patch that delivers bioactive substances (including allergens) through intact skin without disrupting it. Based on the principle of epicutaneous immunotherapy (EPIT), it delivers allergens directly to the superficial layers of the skin, activating the host immune system by specifically targeting antigen-presenting cells (APCs) without allowing allergens to enter the bloodstream.In addition to Viaskin Peanut, DBV Technologies is also developing Viaskin patches for the treatment of dust mite allergy and milk allergy.

Recently, DBV disclosed regulatory updates for Viaskin Peanut in the US and Europe in its Q3 financial report:

——Regarding US regulatory affairs: On October 14, 2021, DBV received a letter from the FDA concerning the STAMP trial protocol submitted on May 6, 2021.FDAA stepwise approach has been requested for the development program of DBV's modified Viaskin Peanut (mVP) (stepwiseapproach"). Prior to providing supplementary comments on the design of the STAMP trial protocol, the FDA wishes to review the data from DBV's protein uptake and release study. In its communication, the FDA indicated that guidelines will soon be issued regarding the optimal approach to demonstrate the comparability of protein uptake between the mVP and the reference or current patch (cVP). Upon DBV's receiptFDAThe STAMP trial will not be initiated until the complete feedback is received.

—— Regarding EU regulatory affairs: In accordance with established EMA procedures and ongoing dialogue with the Agency, the EMA is reviewing the Marketing Authorization Application (MAA) for Viaskin Peanut. DBV is preparing its response to the Day 180 letter and evaluating how best to address the objections, including the remaining major objection concerning data limitations, such as the clinical relevance and effect size supported by a single pivotal study. The Company anticipates further discussions with the EMA. DBV estimates that the EMA may issue a decision regarding the potential marketing authorization for Viaskin Peanut in the first quarter of 2022.

DBV Technologies Chief Executive Officer Daniel Tasse stated: “DBV is actively working to identify an efficient and timely path forward. Currently, the peanut allergy patient community is urgently awaiting therapeutic advancements in this field, and DBV will continue its efforts to bring Viaskin Peanut to the food allergy community.”

Peanut allergy is one of the most common food allergies globally,In the United States alone, more than 1.6 million children and adolescents have a peanut allergy. Historically, the standard of care for children and adolescents with peanut allergy has been a strict peanut elimination diet, along with the prompt administration of rescue medication in the event of an allergic reaction triggered by accidental peanut ingestion. Despite maintaining a high level of vigilance, accidental ingestion can still occur, resulting in allergic reactions of unpredictable severity and a lifelong risk of severe allergic reactions.

In February 2020, Aimmune Therapeutics'Peanut Allergy Oral Immunotherapy Palforzia (Peanut Allergen Powder-dnfp, AR101) Receives U.S.FDA, becoming the world's first approved therapy for the treatment of peanut allergy, as well as the world's first approved therapy for the treatment of any food allergy.

Palforzia utilizes Aimmune Therapeutics' proprietaryOral Desensitization Immunotherapy (CODIT) Therapeutic PlatformThe first product developed, this platform aims to desensitize patients using well-defined, precise doses of key allergens, thereby providing a meaningful level of protection against immune responses triggered by accidental ingestion of food allergens.

Palforzia is a fixed-composition powder composed of key allergens extracted from peanuts., packaged in pull-apart color-coded capsules (for dose escalation and titration) and sachets (300 mg/sachet, for maintenance therapy). For administration, remove the powder from the capsule or sachet, mix with a small amount of semi-solid food (such as applesauce, yogurt, or pudding), and consume.

The peanut allergy market is valued at $3 billion.。As the first drug for the treatment of peanut allergy, the industry is highly optimistic about Palforzia's commercial prospects. Pharmaceutical market research firm EvaluatePharma previously projected that Palforzia's sales in 2024 are expected to reach $1.75 billion. (Bioon.com)

Original Source:DBV Technologies Reports Third Quarter 2021 Financial Results and Recent Regulatory Developments