DBV Technologies announced that the first patient has been enrolled in EPITOPE ( EPIT in TO ddlers with PE anut Allergy), a global, Phase III clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic patients one to three years of age.
Viaskin Peanut is the company's lead product candidate, which is based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that delivers biologically active compounds to the immune system through the skin.
" With results from our ongoing Phase III trial of Viaskin Peanut in peanut-allergic children four to 11 years of age expected later this year, the launch of EPITOPE, our second Viaskin Peanut Phase III program, highlights our commitment to accelerating innovation in the field of food allergies," said Dr. Hugh Sampson , Chief Scientific Officer of DBV Technologies, Director of the Jaffe Food Allergy Institute at Mount Sinai, and the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai. " Recent studies in the field suggest that treating patients from a younger age may lead to significant therapeutic benefit, and Viaskin may be able to offer a safe, effective and convenient treatment for these younger children."
EPITOPE is a two-part, pivotal, double-blind, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut in children one to three years of age. Part A of the trial will assess the safety of two doses of Viaskin Peanut, 100 µg and 250 µg in approximately 50 patients for three months. Based on the results from Part A, the highest safe dose will be studied in Part B, which will enroll approximately 281 additional patients to evaluate the safety and efficacy of the identified dose versus placebo for 12 months. The primary efficacy endpoint of the study is based on a responder analysis after 12 months of treatment of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC).
Dr. Wesley Burks , Curnen Professor of Pediatrics, University of North Carolina School of Medicine, and Principal Investigator of the EPITOPE study, said: " Seeing the first patient enrolled in this trial represents another important step forward towards exploring treatments for patients suffering from peanut allergy. We have seen an increase in the diagnosis of this disease within the first few years of life, representing a high unmet medical need for these young children."
EPITOPE is expected to enroll approximately 331 patients (50 in Part A and 281 in Part B) in approximately 20 - 40 centers across North America (Canada and the United States), Ireland, and Australia.
The EPITOPE trial is a two-part trial: Part A is designed to assess the safety of Viaskin Peanut 100 µg and 250 µg to determine the highest safe dose, and Part B is designed to assess the safety and efficacy of the highest safe dose selected in Part A. In Part A, patients are randomized 1:2:2 to receive either placebo or Viaskin Peanut 100 mcg or 250 mcg for three months. A safety analysis will be performed after three months to determine the highest safe dose to be studied in Part B. If there are no safety concerns with either of the two doses, patients will continue on their respective treatment and remain on the same active dose or placebo they received in Part A. In Part B, patients will be randomized 2:1 to receive the selected dose of Viaskin Peanut or placebo.
The primary endpoint is based on a responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo controlled food challenge (DBPCFC). For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder is defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), will also be evaluated in EPITOPE to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
About DBV Technologies
DBV Technologies is developing Viaskin®, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV's method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV's food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical study of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases.
DBV Technologies has global headquarters in Montrouge, France and New York, NY. Company shares are traded on segment A of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing one-half of one ordinary share) (Ticker: DBVT). For more information on DBV Technologies, please visit our website: www.dbv-technologies.com