Montrouge, France, September 21 (11:45 PM CEST), 2022
DBV Technologies fevaluate 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 US Food and Drug Administration (FDA) regarding the SPEED Phase 3 clinical trial. (INIaskin Peanuts meimmunotherapy Trial to Evalue WITHsafety, WITHimplicitly a 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. To achieve the study objectives, protocol elements 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 started screening or recruiting subjects for the VITESSE study. This partial clinical suspension only applies to the VITESSE study; it has no impact on other ongoing clinical trials conducted by DBV. The company plans to provide an update after consulting with the FDA.
“NOTWe appreciate FDA’s additional comments that reflect careful consideration of the study. vsSPEED line,” said Daniel Tassé, CEO of DBV Technologies. “we appreciate that comments be clear and concise a that these Arrived before the start of recruitment. We look forward to further discussions with the staff from meto the FDA.”
VITESSE is a randomized, double-blind, placebo-controlled phase 3 clinical trial to evaluate 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 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 Viaskin Peanut clinical trials. 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 the B segment 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, the timing and projection of key milestones in the VITESSE study, and the timing and expected outcomes of interactions with regulatory agencies. All statements regarding VITESSE study milestones, recruitment and expected results herein are DBV’s best estimates and projections and are based on the results 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 identified in DBV Technologies’ regulatory filings with the Autorité des marchés financiers (“AMF”), DBV Technologies’ filings and reports to the US Securities and Exchange Commission (“SEC”) and future filings and reports from 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.
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Viaskin and EPIT are registered trademarks of DBV Technologies.