DBV Technologies and Viaskin® : a great success

In a recent post (Allergies: Epidemic in sight, Research needed or the allergies_ Les allergies_ épidémie en vue, recherche indispensable), I mentioned the challenge posed by the explosion of allergies and the need for research to understand the cause and find remedies. I would like to mention a superb french success in an area which has not so much: Viaskin^® from DBV technologies, a promising technology in the treatment of food allergies

Viaskin^® Peanut :

In July 2010, DBV launched the first clinical trial of Viaskin^® Peanut in the United States. Viaskin^® Peanut is a patch, which applies to the upper arm, designed to treat allergies to peanuts and peanut-containing products desensitizing patients. Early October 2015, results from phase 2 clinical (study Olfus) confirmed the hopes of the company and of patients. In 12 months of treatment with Viaskin Peanut 250 μg, answering patients rate is passed to 70% from 50% compared to the shorter initial study – which was already not bad.  'Responder' patients have been defined by their ability to reach a dose reactive protein of peanut equal to or greater than 1000 mg of protein of peanut or by an increase of ≥ 10 times the initial reactive dose. Viaskin peanuts desensitization works well, it works even better, what is important, in children from 4 to 11 years. Safety is perfect, no serious adverse effects were observed, which is reflected in the excellent rate of adherence to treatment (96%), a parameter also very important to successful desensitization.

The early hopes placed in Viaskin ® Peanut are therefore confirmed, making it the most effective treatment and best tolerated to treat peanut allergy. Efficacy in children is an important asset; more it desensitizes early, better it is. "Viaskin could become a revolutionary treatment for children with Peanut Allergy." (Dr. James R. Baker, Director of Fare, main food allergic patients association in the United States)

Viaskin^® - EPIT ® technology

 Viaskin^® is an electrostatic patch which uses electrostatic forces to keep the dry active principle (Antigen) on the surface of the patch which is in contact with the skin. It is easy to use, can be self-administered, requires no special preparation of the skin and is not invasive. It is based on EPIT^® technology (Epicutaneous immunotherapy). EPIT^® targets epidermal Langerhans cells that have the potential to induce an immune response, while posting a profile highly tolerogenic. Applying the allergen directly at the level of the lymph through the Langerhans cells, EPIT^® activates (Tregs) regulatory T cells able to regulate the Th2 reaction to the allergen. EPIT^® safety relates to the lack of passage of allergens into the bloodstream, while its effectiveness is attributable to activity present in the lymph node. Administration of the allergen by Viaskin^® results in its release into the superficial layer of the skin, avoiding any passive passage in the dermis, the lymphatic system or bloodstream. The epicutaneous immunotherapy can treat patients without inducing systemic allergic reactions such as anaphylaxis, extremely serious and sometimes fatal. The safety profile of the method and immunomodulation induced by EPIT^® could allow the treatment of allergies very early in life.

This technology had to be implemented in a practical way, and this is what does the Viaskin^® patch. Viaskin^®, an innovative pharmaceutical process, uses an electrospray for spraying layers of homogeneous protein, fine and dry on the patch, allowing it to deliver proteins through intact skin. The Viaskin^® patch contains the antigen in dry form, which provides an optimal preservation of its chemical properties. It creates a condensation chamber with the skin which increases the skin's natural moisture and solubilizes the antigen, allowing it to penetrate into the upper layers of the epidermis. The antigen is then close to antigen-presenting Langerhanss cells, without going into the bloodstream.

 A significant public health issue.  And Europe?

 Approximately 3 to 5% of Americans suffer from food allergies, and the situation is worsening, with a growing proportion of children affected: up to 8% of children have a food allergy. Patients developing this type of allergy are particularly at risk to major disruption in their daily lives and early treatment of allergies may prevent the progression of the disease or the development of poly-allergies. However, no approved treatments are currently on the market for young allergic children.

That predicts a beautiful deserved success for Viaskin^® Peanut and little brothers less advanced: Viaskin^® Milk, for the treatment of allergy to milk cow,  and Viaskin^® Egg, for the treatment of allergy to eggs, and for the company DBV Technologies. And a question: why market introduction of such innovative treatments seems to be more difficult in Europe than in the USA, even when the inventor company is European ? There is, in the field of therapeutic innovation, something that does not work well