DBV Technologies will study its experimental allergy skin patch Viaskin® as a potential new treatment for Crohn’s disease in a collaboration launched with Icahn School of Medicine at Mount Sinai. The value of the collaboration was not disclosed.
The collaboration will explore a first-in-class approach to treating Crohn's through delivery directly to the skin with Viaskin. The treatment is designed to induce tolerance through regulatory cells (Treg) such as those examined previously by Mount Sinai researchers, as well as decrease gut inflammation.
In a series of activities and studies expected to last 12 months, DBV and Mount Sinai will evaluate the ability of epicutaneous tolerance induction with Viaskin to treat inflammatory colitis; and demonstrate the functional ability of antigen-specific Tregs induced by direct-to-skin exposure with Viaskin in suppressing inflammatory responses in the gut.
The studies are also designed to acquire better knowledge of cellular mechanisms involved. Sinai researchers have previously shown the safety and efficacy of Tregs administered to patients with severe Crohn's disease.
“We believe this new research area with such a center of excellence further emphasizes the potential of the Viaskin platform, positioning it as a technology enabling a deep and durable modulation of the immune system," Pierre-Henri Benhamou, M.D., DBV’s chairman and CEO, said in a statement.
In several pre-clinical studies, DBV showed that repeated epicutaneous immunotherapy (EPIT™) leads to increase natural and induced immune regulatory cells. Preliminary studies already showed that these immune regulatory cells protect the gut from inflammation.
Established in 2002, publicly-traded DBV has developed two products. Viaskin Milk enjoyed promising pilot study results in 2009 showing that after only three months of treatment, the dose of milk tolerated by patients had increased 12-fold. The other product, Viaskin Peanut, won FDA’s Fast Track designation for its clinical development of Viaskin Peanut after showing in a Phase Ib study of 100 patients that it was safe and well-tolerated by adults, adolescents and children with peanut allergy, regardless of the severity of the allergy.
Later this year, DBV expects to read out topline results from the worldwide Phase II Viaskin Peanut’s Efficacy and Safety (VIPES) study of 220 peanut-allergic child and adult patients in Europe and North America.
“This new technology could offer to our patients' new opportunities and pave the way for an original approach aiming at amplifying the effect of immune regulatory cells instead of targeting immune suppression and its associated potential side effects,” added Jean-Frédéric Colombel, M.D., director of The Leona M. and Harry B. Helmsley Charitable Trust Inflammatory Bowel Disease Center at Mount Sinai.
Dr. Colombel participated in the identification of NOD2 as a susceptibility gene for Crohn's, in the identification of a new subtype of Escherichia coli associated with the disease, as well as the development of the Anti-Saccharomyces Cerevisiae Antibody test, the most sensitive and specific marker for Crohn's disease.