Montrouge, France, September 21 (11:45 p.m. CEST), 2022
DBV Applied sciences ftake inventory of the examine clinique de part 3 VITESSE
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, as we speak introduced that it has acquired feedback from the U.S. Meals and Drug Administration (FDA) concerning its examine SPEED Part 3 scientific trial (Viaskin Peanut Immunotherapy Trial to Evaluate Safet, Simplicity and Efficacy).
Within the partial scientific suspension letter, the FDA outlines modifications to be made to sure parts of the VITESSE protocol, as a part of a future BLA submission. So as to obtain the targets of the examine, the weather of the protocol mentioned within the letter concern: the statistical evaluation of adherence, the period of every day carrying of the patch, the information categorization methodologies, and the full variety of trial contributors receiving lively remedy.
DBV has not but began screening or recruiting topics for the VITESSE examine. This partial scientific suspension solely issues the VITESSE examine; there isn’t a affect on different ongoing scientific research carried out by DBV. The corporate plans to offer an replace after session with the FDA.
“NWe’re grateful for the extra feedback from the FDA reflecting the cautious consideration paid to the examine. cSPEED line,” mentioned Daniel Tassé, CEO today techs of DBV Applied sciences. “We respect that feedback be clear and concise et that these have arrived earlier than the beginning of recruitment. We stay up for additional discussions with employees of la FDA.”
VITESSE is a part 3, randomized, double-blind, placebo-controlled scientific examine geared toward evaluating the efficacy and security of epicutaneous immunotherapy with the modified Viaskin™ Peanut patch, in kids aged from 4 to 7 years outdated with peanut allergy.
About DBV Applied sciences
DBV Applied sciences is today techs creating Viaskin™, an experimental proprietary expertise platform with broad potential functions in immunotherapy. Viaskin relies on Epicutaneous Immunotherapy, or EPIT™, and is DBV Applied sciences’ methodology of delivering biologically lively compounds to the immune system by means of intact pores and skin. With this new class of non-invasive product candidates, the Firm goals to securely remodel the remedy of today techs sufferers with meals allergy symptoms. DBV Applied sciences’ meals allergy applications embrace ongoing scientific trials of Viaskin Peanut. DBV Applied sciences’ international headquarters are situated today techs in Montrouge, France, and its North American operations are based mostly in Basking Ridge, NJ. The Firm’s extraordinary shares are traded on phase B of Euronext Paris (image: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing half an extraordinary share) are traded on the Nasdaq International Choose Market ( image: DBVT).
This press launch could comprise forward-looking statements and estimates, together with statements concerning the therapeutic potential of Viaskin™ Peanut as a remedy for youngsters with peanut allergy and the potential advantages of EPIT™, scientific growth and DBV Applied sciences’ regulatory plans, the timing and projections of key milestones within the VITESSE examine, and the timing and anticipated outcomes of interactions with regulatory companies. All statements concerning VITESSE examine milestones, recruitment, and anticipated outcomes contained herein are DBV’s greatest estimates and projections and are based mostly on efficiency of prior research. They’re topic to identified and unknown dangers, uncertainties and different elements that might trigger the precise outcomes, efficiency and achievements of the VITESSE examine to vary materially from the estimates and projections contained herein. doc. These forward-looking statements and estimates don’t represent guarantees or ensures and contain important dangers and uncertainties and could also be impacted by market circumstances in addition to different dangers and uncertainties set forth in DBV Applied sciences’ regulatory filings with the Autorité des marchés financiers (“AMF”), DBV Applied sciences filings and reviews with the US Securities and Change Fee (“SEC”), today techs and future filings and reviews with the AMF. Present and potential traders are cautioned to not place undue reliance on such forward-looking statements and estimates, which converse solely as of the date hereof. Besides as required by relevant regulation, DBV Applied sciences doesn’t undertake to replace or revise the data contained on this press launch.
DBV Applied sciences
DBV Applied sciences
Viaskin and EPIT are registered emblems of DBV Applied sciences.