Montrouge, France, September 21 (11:45 p.m. CEST), 2022
DBV Technologies ftake stock of the study clinical phase 3 SPEED
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that it has received comments from the U.S. Food and Drug Administration (FDA) regarding its study SPEED Phase 3 clinical trial (VIaskin Peanut Immunotherapy Trial to Evalue Safety, Simplicitly and Eefficiency).
In the partial clinical suspension letter, the FDA outlines changes to be made to certain elements of the VITESSE protocol, as part of a future BLA submission. In order to achieve the objectives of the study, the elements of the protocol discussed in the letter concern: the statistical analysis of adherence, the duration of daily wearing of the patch, the data categorization methodologies, and the total number of trial participants receiving active treatment.
DBV has not yet started screening or recruiting subjects for the VITESSE study. This partial clinical suspension only concerns the VITESSE study; there is no impact on other ongoing clinical studies conducted by DBV. The company plans to provide an update after consultation with the FDA.
“NOTWe appreciate the additional comments from the FDA reflecting the study’s careful consideration. vsSPEED line,” said Daniel Tassé, CEO of DBV Technologies. “We appreciate that comments be clear and concise and that these have arrived before the start of recruitment. We look forward to further discussions with staff of Ito FDA.”
VITESSE is a phase 3, randomized, double-blind, placebo-controlled clinical study aimed at evaluating the efficacy and safety of epicutaneous immunotherapy with the modified Viaskin™ Peanut patch, in children aged from 4 to 7 years old with peanut allergy.
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, the timing and projections of key milestones in the VITESSE study, and the 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 of prior 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 herein. document. These forward-looking statements and estimates do not constitute promises or guarantees and involve significant risks and uncertainties and may be impacted 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 filings and reports with the US Securities and Exchange Commission (“SEC”), and future filings and reports with the AMF. Current and potential investors are cautioned not to place undue reliance on such forward-looking statements and estimates, which speak only as of the date hereof. Except as required by applicable law, DBV Technologies does not undertake to update or revise the information contained in this press release.
Investor contacts
Anne Pollack
DBV Technologies
+1 857-529-2363
[email protected]
Contact media
Angela Marcucci
DBV Technologies
+1 646-842-2393
[email protected]
Viaskin and EPIT are registered trademarks of DBV Technologies.
