Montrouge, France, March 7 (10:30 p.m. CET) 2023
DBV Technologies announces the screening of the first patient of the VITESSE phase 3 clinical trial in children aged 4 to 7 years old allergic to peanuts.
Screening of the first patient at Midwest Allergy Sinus Asthma in Normal, Illinois
SPEED is DBV’s Phase 3 clinical study evaluating the modified Viaskin Peanut Patch in children aged 4-7 years with peanut allergy.
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the screening of the first patient in the Phase 3 clinical study VITESSE (
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fficacy)) which will evaluate the modified Viaskin™ Peanut 250 μg patch (DBV712) in children aged 4 to 7 years old with peanut allergy.
Viaskin Peanut 250 μg is a new treatment designed to re-educate the immune system by introducing microgram amounts of peanut allergen into the immune system through intact skin. The VITESSE study will use the modified Viaskin Peanut 250 μg patch and will enroll 600 subjects, randomized double-blind (2:1) to placebo. The study will involve approximately 80 clinical sites in the United States, Canada, Australia and Europe. The main measure of effectiveness is the percentage of people responding to treatment in the active arm compared to the placebo arm at 12
th
month. Secondary efficacy endpoints include changes in Cumulative Reactive Dose, Reactive Dose and severity of allergic reaction upon oral challenge at 12
th
month.
“I am happy that the first patient in the VITESSE study has been screened”,
said Dr. David Fleischer, MD, FAAAAI, FACAAI, Children’s Hospital Colorado and worldwide principal investigator of the VITESSE study,
“These peanut-allergic children represent a cohort of patients who are eagerly awaiting potential treatment options. I am excited to lead the team of highly skilled investigators and their collaborators engaged in the VITESSE study. to generate this critical data that could one day potentially support a BLA application for Viaskin Peanut.”
Last year, following constructive discussions with the US Food and Drug Administration (FDA), DBV finalized the VITESSE protocol and received support from the FDA to move the study forward. Previously, the FDA had requested changes to certain elements of the VITESSE protocol so that the study could support a future Biological License Application (BLA).
” T he initiation of the Phase 3 VITESSE study in children aged 4 to 7 years with peanut allergy represents the culmination of years of research and collaboration between DBV, the FDA, patient associations, investigators from sites, the clinical sites and, of course, the unwavering support and encouragement of families with food allergies”,
said Pharis Mohideen, Medical Director of DBV Technologies.
“DBV is proud to see that patient screening commenced in the first quarter of 2023. This milestone reflects the incredible work of the DBV team in preparing for the launch of the study, and the promptness to begin recruitment of key investigators like Dr. Dareen Siri and others. We are very grateful for the strong collaboration that will continue throughout the VITESSE study.”
Principal Investigator Dr. Dareen Siri, FAAAAI, FACAAI of Midwest Allergy Sinus Asthma, Normal and Springfield, Illinois, was the first to perform the screenings for these potential new patients.
“I am delighted that our talented team of clinicians were the first to screen a patient for the VITESSE clinical study”
said Dr. Dareen Siri, Midwest Allergy Sinus Asthma, Normal, Illinois.
“The initiation of patient recruitment in the VITESSE study reinforces our commitment to peanut allergic children and their families and is an important step in generating the data necessary for the eventual commercialization of Viaskin Peanut. I am pleased that children with peanut allergies have the opportunity to participate in a trial that could one day help other children living with peanut allergy like them. era that our team is an integral part of it”.
DBV expects the screening of the last patient in the first half of 2024 and the announcement of the first results in the first half of 2025.
About SPEED
The VITESSE study will include 600 patients, randomized in a 2:1 ratio to receive either active treatment or placebo. The study will involve approximately 80 clinical sites in the United States, Canada, Australia and Europe. David Fleischer, MD, of Children’s Hospital Colorado, will be the global principal investigator.
The primary efficacy endpoint is the percentage of people responding to treatment in the active group compared to the placebo group at 12
th
month. The primary efficacy analysis includes a success criterion with a lower limit of the confidence interval, of the difference in response rates between the active and placebo groups, greater than or equal to 15%.
A responder is defined as a patient with a baseline reactive dose (RD) ≤ 30 mg who achieves an RD ≥ 300 mg peanut protein at month 12, or a patient with a baseline RD = 100 mg who achieved an DR of ≥600 mg peanut protein at month 12. A double-blind, placebo-controlled oral challenge (DBPCFC, Double-Blind, Placebo-Controlled Food Challenge) will be administered at study entry and at month 12 to determine a patient’s DR at both time points.
During the screening period, patients will undergo an initial screening visit with an eligibility assessment based on peanut skin test (PT) and anti-peanut serum IgE assay. Those who meet these criteria will complete a double-blind, placebo-controlled oral peanut challenge test (DBPCFC) to confirm their peanut allergy and establish a DR at study entry. The starting dose for eligibility will be 1 mg of peanut protein and will be increased to a single highest dose of 100 mg of peanut protein.
Patients who respond with a DR at 100 mg peanut protein or lower and who meet all other inclusion and exclusion criteria are considered eligible. At 12
th me
months, a post-treatment oral challenge test (DBPCFC) will be performed, with a starting dose of 3 mg peanut protein, with gradual increase to the highest dose of 1000 mg peanut protein according to the following scheme: 3, 10, 30, 100, 300, 600, 1000 mg. Secondary efficacy endpoints include changes in cumulative reactive dose, reactive dose, and severity of allergic reaction in the 12-month oral challenge test.
About DBV Technologies
DBV Technologies is developing Viaskin™, an experimental proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on Epicutaneous Immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company aims to safely transform the treatment of patients with food allergies. DBV Technologies’ food allergy programs include ongoing clinical trials of Viaskin Peanut. DBV Technologies’ global headquarters are located in Montrouge, France, and its North American operations are based in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (symbol: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing half an ordinary share) are traded on the Nasdaq Global Select Market ( symbol: DBVT).
Forward-looking statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin™ Peanut as a treatment for children with peanut allergy and the potential benefits of EPIT™, clinical development and DBV Technologies’ regulatory plans, timing and projections of VITESSE study milestones, and timing and anticipated results of interactions with regulatory agencies. All statements regarding VITESSE study milestones, recruitment, and expected outcomes contained herein are DBV’s best estimates and projections and are based on performance from prior studies. They are subject to known and unknown risks, uncertainties and other factors that could cause actual results, performance and achievements of the VITESSE study to differ materially from the estimates and projections contained herein. document.
These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties and may be affected by market conditions as well as other risks and uncertainties set forth in DBV Technologies’ regulatory filings with the ‘Autorité des Marchés Financiers’ (“AMF”), DBV Technologies’ documents and reports filed with the US Securities and Exchange Commission (“SEC”) and future documents and reports filed with the AMF and the SEC. Current and potential investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date of this document. Except as required by applicable law, DBV Technologies does not undertake to update or revise the information contained in this press release.
Contact Investor Relations
Anne Pollack
+1 (857) 529-2363
Media contacts
Angela Marcucci
+1 (646) 842-2393
[email protected]
Viaskin and EPIT are registered trademarks of DBV Technologies
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