DBV’ lead product candidate, Viaskin® Peanut, is being developed for the treatment of peanut allergies in adults and children.
On September 22nd, 2014, we have announced topline results for our VIPES (Viaskin® Peanut’s Efficacy and Safety) phase IIb clinical trial of Viaskin Peanut in peanut allergic patients.
The trial met its primary endpoint at the highest explored dose (Viaskin Peanut 250 µg), achieving statistical significance (p=0.0108) in desensitizing a higher proportion of patients versus placebo after 12 months of Epicutaneous Immunotherapy (EPIT®). Patients treated with Viaskin Peanut 250 µg also showed statistically significant changes in measured serological markers while placebo patients did not exhibit material differences. The safety profile was confirmed across all active arms with no serious treatment-related adverse events reported, and patient compliance with daily Viaskin Peanut application was above 97%. The trial drop-out rate was 6.4%, below the 15% rate initially anticipated. The VIPES trial is the largest clinical trial in peanut allergy desensitization ever completed, and full results of efficacy and safety will presented at future scientific meetings.
Viaskin® Peanut is an investigational product and has not been approved for any use in any country, including, but not limited to, the United States, Canada, the European Union or Australia.
Our second product candidate, Viaskin® Milk, is being developed for children (including infants) for the treatment of milk allergy and EoE.
Proof-of-concept data from a pilot clinical trial of Viaskin® Milk was published in The Journal of Allergy and Clinical Immunology in 2010.
In the second half of 2014, DBV Technologies intend to initiate MILES trial, a multi-center, double-blind, placebo-controlled, randomized Phase I/II safety and efficacy clinical trial of Viaskin® Milk in the pediatric patient population with CMPA. In the first half of 2015, with DBV Technologies assistance, the Children’s Hospital of Philadelphia intends to initiate a multi-center, double-blind, placebo-controlled, randomized trial to study safety and efficacy of Viaskin® Milk in pediatric patient populations with milk-induced EoE.
Viaskin® Milk is an investigational product and has not been approved for any use in any country, including, but not limited to, the United States, Canada, the European Union or Australia.
We are also developing Viaskin® Egg as a treatment that we believe can reduce the clinical manifestations of hen’s egg allergy.
We recently begun pre-clinical work for this product candidate with the goal of initiating a clinical program if these studies are successful.
Viaskin® Egg is a product under pre-clinical development and has not been approved for any use in any country, including, but not limited to, the United States, Canada, the European Union or Australia.