Montrouge, France, September 21 (23:45 CEST) 2022
sum up the research
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical stage biopharmaceutical company, announced today that it has received comments from the U.S. Food and Drug Administration (FDA) regarding its study SPEED Phase 3. (
In the partial clinical suspension letter, the FDA describes the changes that need to be made to some elements of the VITESSE protocol as part of a future BLA submission. To achieve study objectives, the elements of the protocol discussed in the letter relate to: statistical analysis of adherence, duration of daily patch wear, data categorization methodologies, and total number of study participants receiving active treatment.
DBV has not yet begun screening or recruiting subjects for the VITESSE study. This partial clinical suspension applies only to the VITESSE study; this does not affect other ongoing clinical studies conducted by DBV. The company plans to provide an update after consultation with the FDA.
We are grateful to the FDA for additional comments reflecting the thoroughness of the study.
said Daniel Tasse, CEO of DBV Technologies. “
clear and concise
as well as
before the start of the set.
We look forward to further discussions with staff
to the FDA
VITESSE is a Phase 3, randomised, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of skin immunotherapy with Viaskin™ Modified Peanut Patch in children aged 4 to 7 years with peanut allergy.
About DBV Technologies
DBV Technologies is developing Viaskin™, an experimental patented technology platform with broad application potential in immunotherapy. Viaskin is based on cutaneous immunotherapy, or EPIT™, and is a method of delivering biologically active compounds to the immune system through intact skin developed by DBV Technologies. With this new class of non-invasive product candidate, the company aims to safely transform the treatment of patients with food allergies. DBV Technologies’ food allergy programs include an ongoing Viaskin peanut clinical trial. DBV Technologies’ global headquarters is located in Montrouge, France, and its North American operations are based in Basking Ridge, New Jersey. The Company’s ordinary shares are traded on the B segment of Euronext Paris (symbol: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing half of a common 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 about the therapeutic potential of Viaskin™ Peanut as a treatment for children with peanut allergy and the potential benefits of EPIT™, DBV Technologies’ clinical developments and regulatory plans, timing and milestone projections VITESSE studies, as well as the timing and expected results of interaction with regulatory authorities. All statements regarding the VITESSE study milestones, recruitment, and expected results contained herein are DBV’s best estimates and predictions and are based on previous studies. They are subject to known and unknown risks, uncertainties and other factors that could cause the actual results, performance and achievements of the VITESSE study to differ materially from the estimates and projections contained in this document. These forward-looking statements and estimates are not promises or guarantees and involve significant risks and uncertainties and may be affected by market conditions and other risks and uncertainties set out in DBV Technologies’ regulatory documents in Autorité des Marchés financiers (“AMF”). ”), DBV Technologies documents and reports to the US Securities and Exchange Commission (“SEC”), and future documents and reports to AMF. Current and potential investors are cautioned not to place undue reliance on such forward-looking statements and estimates, which are valid only as of the date hereof. Except as required by applicable law, DBV Technologies makes no commitment to update or revise the information contained in this press release.
Viaskin and EPIT are registered trademarks of DBV Technologies.