Montrouge, France, 21 September (23:45 CEST), 2022.
DBV Technologies ftake a look at the study clinical phase 3 SPEEDS
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that it has received comments from the US Food and Drug Administration (FDA) regarding the SPEED tri Phase 3 clinical study (VIaskin Peanut Iimmunotherapy Trial to Evalue Ssafety, 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 study objectives, the protocol elements discussed in the letter concern: statistical analysis of adherence, duration of daily patch wear, data categorization methodology, and 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 applies only to the VITESSE study; no impact on other ongoing clinical studies conducted by DBV. The company plans to provide an update after consulting with the FDA.
“NOWe appreciate the FDA’s additional comments reflecting careful consideration of the study. vsSPEED line,” said Daniel Tassé, CEO of DBV Technologies. “We appreciate that comments be clear and concise and yes these have arrived before the start of employment. We look forward to further discussions with the staff of Ito the FDA.”
VITESSE is a phase 3, randomized, double-blind, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of epicutaneous immunotherapy with a modified Viaskin™ peanut patch in children aged 4 to 7 years with peanut allergy.
About DBV Technologies
DBV Technologies is developing Viaskin™, an experimental proprietary technology platform with broad application potential 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 located 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 of an ordinary share) are traded on the Nasdaq Global Select Market (symbol: DBVT).
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™, DBV Technologies’ clinical development and regulatory plans, timing and projections of key milestones in the VITESSE study, and the timeline and expected 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 the performance of 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 herein. These forward-looking statements and estimates do not constitute promises or guarantees and involve significant 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’ filings and reports with the US Securities and Exchange Commission (“SEC”), and future filings and reports with the AMF. Current and prospective 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 undertakes no obligation to update or revise the information contained in this press release.
Viaskin and EPIT are registered trademarks of DBV Technologies.