Montrouge, France, September 21, 2022
DBV Technologies Provides Clinical Update on VITESSE Phase 3 Trial
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical firm, as we speak introduced that it obtained suggestions from the U.S. Food and Drug Administration (FDA) within the type of a partial scientific maintain on its VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 scientific research.
In the partial scientific maintain letter, the FDA specifies modifications to components of the VITESSE protocol with the intent for the trial to assist a future BLA submission. Within the FDA’s communication, the modifications tackle design components, together with the statistical evaluation of adhesion, minimal each day put on time and technical alignments in strategies of categorizing information, to fulfill research aims in addition to the whole variety of trial contributors on energetic therapy.
DBV has not but begun the screening or recruitment of topics within the VITESSE research. The partial scientific maintain is restricted to VITESSE and doesn’t influence another ongoing DBV scientific research. The Company expects to supply extra updates following session with the FDA.
“We are grateful for the FDA’s additional feedback reflecting careful attention to DBV’s VITESSE study,” mentioned Daniel Tassé, Chief Executive Officer of DBV Technologies. “We are pleased that the comments to the protocol are specific, clear and arrived prior to enrollment. We look forward to upcoming discussions with key FDA personnel.”
VITESSE is a Phase 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 youngsters ages 4 to 7 years.
About DBV Technologies
DBV Technologies is growing Viaskin™, an investigational proprietary know-how platform with broad potential purposes in immunotherapy. Viaskin relies on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ technique of delivering biologically energetic compounds to the immune system by means of intact pores and skin. With this new class of non-invasive product candidates, the Company is devoted to securely reworking the care of meals allergic sufferers. DBV Technologies’ meals allergic reactions applications embody ongoing scientific trials of Viaskin Peanut. DBV Technologies has international headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s bizarre shares are traded on phase B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (every representing one-half of 1 bizarre share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
This press launch could comprise forward-looking statements and estimates, together with statements concerning the therapeutic potential of Viaskin™ Peanut as a therapy for peanut-allergic youngsters and the potential advantages of EPIT™, DBV Technologies’ scientific 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 greatest estimates and projections are primarily based on efficiency of earlier research and are topic to identified and unknown dangers, uncertainties, and different components which 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 are usually 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 Technologies’ regulatory filings with the Autorité des Marchés Financiers (“AMF”), DBV Technologies’ filings and experiences with the U.S. Securities and Exchange Commission (“SEC”), and future filings and experiences made with the AMF and SEC. Existing 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. Other than as required by relevant regulation, DBV Technologies undertakes no obligation to replace or revise the knowledge contained on this Press Release.
Viaskin and EPIT are logos of DBV Technologies.