Montrouge, France, September 21, 2022
DBV Applied sciences Supplies Scientific Replace on VITESSE today techs Part 3 Trial
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 today techs – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, right now introduced that it obtained suggestions from the U.S. Meals and Drug Administration (FDA) within the type of a partial medical maintain on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safet, Simplicity and Efficacy) Part 3 medical research.
Within the partial medical maintain letter, the FDA specifies modifications to components of the VITESSE protocol with the intent for the trial to help a future BLA submission. Throughout the FDA’s communication, the modifications handle design components, together with the statistical evaluation of adhesion, minimal every day put on time and technical alignments in strategies of categorizing information, to fulfill research goals in addition to the whole variety of trial contributors on lively remedy.
DBV has not but begun the screening or recruitment of topics within the VITESSE research. The partial medical maintain is particular to VITESSE and doesn’t influence some other ongoing DBV medical research. The Firm expects to offer extra updates following session with the FDA.
“We are grateful for the FDA’s extra feedback reflecting cautious consideration to DBV’s VITESSE research,” mentioned Daniel Tassé, Chief Government Officer of DBV Applied sciences. “We’re happy that the feedback to the protocol are particular, clear and arrived previous to enrollment. We glance ahead to approaching discussions with key FDA personnel.”
VITESSE is a Part 3, double-blind, placebo-controlled, randomized research to evaluate the efficacy and security of epicutaneous immunotherapy with the modified Viaskin™ Peanut 250 µg patch in peanut-allergic kids ages 4 to 7 years.
About DBV Applied sciences
DBV Applied sciences is creating Viaskin™, an investigational proprietary know-how 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 via intact pores and skin. With this new class of non-invasive product candidates, the Firm is devoted to securely reworking the care of meals allergic sufferers. DBV Applied sciences’ meals allergy symptoms packages embrace ongoing medical trials of Viaskin Peanut. DBV Applied sciences has world headquarters today techs in Montrouge, France, and North American operations in Basking Ridge, NJ. The Firm’s extraordinary shares are traded on phase B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing one-half of 1 extraordinary share) are traded on the Nasdaq World Choose Market (Ticker: DBVT).
This press launch might include forward-looking statements and estimates, together with statements concerning the therapeutic potential of Viaskin™ Peanut as a remedy for peanut-allergic kids and the potential advantages of EPIT™, DBV Applied sciences’ medical improvement and regulatory plans, timing and projections of VITESSE research milestones, and timing and anticipated outcomes of interactions with regulatory companies. All statements about VITESSE research milestones, enrollment and anticipated outcomes contained herein are DBV’s finest estimates and projections are based mostly today techs on efficiency of earlier research and are topic to recognized and unknown dangers, uncertainties, and different elements that will trigger precise outcomes, efficiency and achievements with respect to the VITESSE research to vary materially from the estimates and projections contained herein. These forward-looking statements and estimates should not guarantees or ensures and contain substantial 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 U.S. Securities and Alternate Fee (“SEC”), and future filings and reviews made with the AMF and SEC. Present and potential buyers are cautioned to not place undue reliance on these forward-looking statements and estimates, which communicate solely as of the date hereof. Apart from as required by relevant regulation, DBV Applied sciences undertakes no obligation to replace or revise the data contained on this Press Launch.
DBV Applied sciences
DBV Applied sciences
Viaskin and EPIT are emblems of DBV Applied sciences.