Two weeks in the past, we reported that DBV Applied sciences was launching a Part 3 medical examine of their redesigned Viaskin Peanut patch in 4-7 year-olds, a remedy supposed to desensitize sufferers to their peanut allergy. DBV was compelled to revamp the patch when the US Meals and Drug Administration (FDA) voiced issues concerning the patch’s adhesion in 2020.
Now the FDA has stepped in once more to situation a partial maintain on the trial, dubbed “VITESSE”. It isn’t recognized how lengthy the FDA’s response will delay the VITESSE trial as DBV will likely be compelled to
Under is the press launch issued by DBV yesterday saying the FDA’s motion.
DBV Applied sciences Supplies Scientific Replace on VITESSE Part 3 Trial
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, in the present day 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 Safety, Simplicity and Efficacy) Part 3 medical examine.
Within the partial medical maintain letter, the FDA specifies adjustments to parts of the VITESSE protocol with the intent for the trial to assist a future BLA submission. Inside the FDA’s communication, the modifications handle design parts, together with the statistical evaluation of adhesion, minimal day by day put on time and technical alignments in strategies of categorizing knowledge, to fulfill examine targets in addition to the whole variety of trial individuals on lively remedy.
DBV has not but begun the screening or recruitment of topics within the VITESSE examine. The partial medical maintain is restricted to VITESSE and doesn’t influence another ongoing DBV medical research. The Firm expects to offer further updates following session with the FDA.
“We are grateful for the FDA’s further feedback reflecting cautious consideration to DBV’s VITESSE examine,” 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 imminent discussions with key FDA personnel.”
VITESSE is a Part 3, double-blind, placebo-controlled, randomized examine to evaluate the efficacy and security of epicutaneous immunotherapy with the modified Viaskin™ Peanut 250 µg patch in peanut-allergic youngsters ages 4 to 7 years.
About DBV Applied sciences
DBV Applied sciences is creating Viaskin™, an investigational proprietary expertise platform with broad potential purposes in immunotherapy. Viaskin is predicated on epicutaneous immunotherapy, or EPIT™, and is DBV Applied sciences’ methodology of delivering biologically lively compounds to the immune system by 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 international headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Firm’s odd 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 odd share) are traded on the Nasdaq World Choose Market (Ticker: DBVT).
This press launch might comprise forward-looking statements and estimates, together with statements relating to the therapeutic potential of Viaskin™ Peanut as a remedy for peanut-allergic youngsters and the potential advantages of EPIT™, DBV Applied sciences’ medical improvement and regulatory plans, timing and projections of VITESSE examine milestones, and timing and anticipated outcomes of interactions with regulatory companies. All statements about VITESSE examine milestones, enrollment and anticipated outcomes contained herein are DBV’s finest estimates and projections are based mostly 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 examine to vary materially from the estimates and projections contained herein. These forward-looking statements and estimates usually are 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 studies with the U.S. Securities and Alternate Fee (“SEC”), and future filings and studies 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 converse solely as of the date hereof. Aside from as required by relevant legislation, 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.