Development Program:
VIASKIN® milk patch

PROGRAM & INDICATION
DEVELOPMENT STAGE
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
Food Allergy
VIASKIN® peanut patch
(DBV712)
Peanut Allergy
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
Ages 1-3 years and 4-7 years
Ages 1-3 years
Ages 4-7 years
Ages 4-11 years
Food Allergy
VIASKIN® milk patch
(DBV135)
Cow's Milk Allergy
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
Ages 2-17 years
Food Allergy
VIASKIN® milk patch
Eosinophilic Esophagitis*
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
Ages 4-17 years
Autoimmune & Inflammatory Disorders
Multiple Programs
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3
Vaccines
Multiple Programs
Discovery
Pre-Clinical
Phase 1
Phase 2
Phase 3

Cow’s Milk Protein Allergy (CMPA) is often the first allergy that appears during early childhood and affects approximately 2-3 percent of the population in developed countries.

We have completed a Phase 1/2 trial to study the safety and efficacy of VIASKIN® milk patch in pediatric and adolescent patients.

Clinical Trials (IgE-mediated Cow’s Milk Allergy)

MILES (VIASKIN® milk patch Efficacy and Safety )

MILES is a multi-center, double-blind, placebo-controlled, randomized Phase 1/2 trial to study the safety and efficacy of VIASKIN® milk patch conducted at 17 sites in North America. The study was divided into two consecutive parts. Part A of the MILES trial was completed with no safety concerns. Part B was designed to determine a safe and effective dose in two age groups: children ages 2 to 11 and adolescents ages 12 to 17 with IgE-mediated cow’s milk protein allergy, or CMPA.

External Collaborations

Pilot Clinical Trial of Epicutaneous Immunotherapy in Cow’s Milk Allergy with Assistance Publique Hopitaux de Paris (AP-HP)

In 2006 a double-blind, placebo-controlled pilot clinical trial was initiated with AP-HP to evaluate the safety of VIASKIN® milk patch in children. This pilot trial enrolled 21 infants (starting at three months) and children (up to age 15) with cow’s milk allergy.

Learn more

* VIASKIN® milk patch is an investigational product and has not been approved for any use in any country.

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