Montrouge, France, September 7, 2022
DBV Technologies Announces Initiation of Phase 3 Study (VITESSE) Using the Modified Viaskin Peanut Patch in Peanut –Allergic Children Ages 4 to 7 Years
- DBV has finalized the VITESSE protocol after productive exchanges with the U.S. Food and Drug Administration (FDA) regarding key examine design components
- DBV expects to display screen the primary affected person in This fall 2022 and anticipates topline outcomes for the VITESSE examine to read out in Q1 2025
- The VITESSE protocol has been submitted to review websites for subsequent Institutional Review Board (IRB)/Ethics Committee (EC) approval
- The Company will host a convention name at 5:30 p.m. ET (11:30 p.m. CEST) on Wednesday, September 7, 2022
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical firm, at the moment introduced the initiation of the Phase 3 examine, VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), utilizing the modified Viaskin™ Peanut Patch, in peanut-allergic kids ages 4 to 7 years. The examine was initiated following productive exchanges with the U.S. Food and Drug Administration (FDA). The protocol has been submitted to review websites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval.
DBV expects to enroll 600 topics for participation within the VITESSE examine, randomized 2:1 lively to placebo. The first affected person screened is predicted in This fall 2022 with the final affected person screened by year-end 2023. The Company anticipates that the topline outcomes will learn out in Q1 2025. Dr. David Fleischer, Colorado Children’s Hospital, will act because the Principal Investigator for the VITESSE examine, which is able to contain roughly 80 examine websites throughout the U.S., Canada, Australia, Europe and the U.Okay.
Over the final a number of months, DBV and the FDA have engaged in ongoing discussions on the epicutaneous immunotherapy (EPIT™) platform as a novel drug -device mixture for delivering allergen immunotherapy and on the VITESSE trial design. These interactions decided that VITESSE will consider the efficacy and security of the modified Viaskin Peanut patch as a peanut allergen immunotherapy, which can probably help a future BLA submission.
Following productive discussions, the FDA granted DBV a Type C assembly in May 2022 to align on the VITESSE examine. The examine protocol was submitted to the FDA as half of the Type C briefing supplies. Subsequent exchanges between DBV and the FDA ensued to align on crucial design components and endpoints, and these have been included within the last protocol that was despatched to review websites.
“We are pleased to have initiated the VITESSE study,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “DBV has engaged in a highly collaborative process with the FDA over the last several months, and we are proud of the final protocol that has been shared with study sites. As I’ve said before, VITESSE means ‘speed’ in French, and we continue to believe that this approach is the fastest way to bring Viaskin Peanut to peanut-allergic children in this age group. Our future patients are counting on us, and we will continue to actively work towards bringing this novel, innovative therapy to the market.”
VITESSE is a Phase 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 kids ages 4 to 7 years. The major efficacy endpoint is the share of therapy responders within the lively versus placebo arms at month 12. The major efficacy evaluation consists of the success criterion of the decrease certain of the boldness interval of the distinction in responder charges between lively and placebo teams being better than or equal to fifteen%.
DBV outlined the VITESSE inclusion standards to deal with the excessive unmet want of youthful, extra delicate peanut allergy sufferers. In meals allergy market analysis and high quality of life research, caregivers report being extremely motivated to guard their baby from a response to an unintended allergen ingestion and stop meals allergy from negatively impacting their baby’s high quality of life. Caregivers cite stressors particular to youthful age teams, similar to a toddler’s incapacity to self-manage their meals allergy, transitions to extra impartial environments similar to daycare and college, and a notion that meals allergy will more and more impression their baby’s high quality of life.
The determination to focus on the 4 to 7-year-old age group displays cautious overview of post-hoc analyses of PEPITES (Peanut EPIT Efficacy and Safety) efficacy information in peanut-allergic kids ages 4 to 11 years, and consideration of the lately introduced EPITOPE (EPIT in TOddlers with PEanut Allergy) information in toddlers ages 1 to 3 years. The VITESSE age inclusion criterion aligns the protocol with an age cohort of peanut allergy sufferers who’ve demonstrated the next response charge in earlier peanut allergy therapy research.
“We look forward to maintaining our work with the FDA, site investigators and other key stakeholders as we advance VITESSE,” stated Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “We feel confident that the VITESSE protocol incorporates all key learnings from our previous Viaskin Peanut studies and advances in the food allergy treatment landscape. We believe that caregivers are motivated to seek treatment options in this patient population.”
A therapy responder is outlined as both a topic with a baseline eliciting dose (ED) ≤30 mg who reaches an ED ≥300 mg of peanut protein at month 12, or a topic with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at month 12. A double-blind, placebo-controlled meals problem (DBPCFC) will probably be administered at baseline and month 12 to find out a topic’s ED at each timepoints. DBV outlined the peanut protein sensitivity inclusion standards to align with peanut allergy sufferers on the biggest threat of experiencing reactions to unintended peanut ingestion and with the very best unmet want. DBV added a 600 mg dose of peanut protein to the month 12 DBPCFC to extend the sensitivity of the efficacy evaluation.
While adhesion of the modified Viaskin Peanut patch will probably be assessed in VITESSE, there isn’t a patch detachment endpoint included within the examine parameters. In VITESSE, adhesion will probably be assessed to affirm the modified Viaskin Peanut patch supplies satisfactory supply of the allergen to the immune system over the course of 12 months. These information will probably be used to help the Sponsor-defined important gadget requirement as per FDA gadget rules for optimum product efficiency. Accordingly, the Instructions for Use (IFU) for the modified patch will direct caregivers to use one patch at roughly the identical time every day, following elimination of the day gone by’s patch. The IFU outlines that Viaskin Peanut 250 µg is to be worn for as near a full day as doable with a minimal day by day put on time of a minimum of 12 hours every day.
Participants will apply the modified patch (both Viaskin Peanut 250 µg or a placebo) day by day for a interval of 12 months. The most examine length per topic is 58 weeks: a four-week screening interval, a 12-month therapy interval and a two-week follow-up interval. During the screening interval, topics will bear an preliminary screening go to with evaluation for eligibility based on peanut pores and skin prick check (SPT) and serum peanut IgE. Those assembly these standards will proceed to a peanut DBPCFC to substantiate their peanut allergy and set up an entry peanut ED. The entry DBPCFC will probably be 1 mg peanut protein, and can escalate as much as a highest single dose of 100 mg peanut protein. Subjects who react with an ED at or under the dose of 100 mg peanut protein are thought-about eligible. At month 12, a post-treatment DBPCFC will probably be carried out, with a beginning dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein based on the next schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints embody modifications in Cumulative Reactive Dose, ED and severity of allergic response at baseline and month 12 meals problem. VITESSE may also consider the security of the modified Viaskin Peanut patch primarily based on total opposed occasions, native website reactions and systemic allergic reactions.
DBV will host a convention name and dwell audio webcast to debate the VITESSE examine on Wednesday, September 7, 2022, at 5:30 p.m. ET. This name is accessible through the under teleconferencing numbers, adopted by the reference ID: 24076524#
- United States : 866 374 5140
- Canada : 866 455 3403
- United Kingdom : 808 238 9813
- France : 805 102 712
A dwell webcast of the decision will probably be obtainable on the Investors & Media part of the Company’s web site: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation may also be obtainable on DBV’s web site after the occasion.
About the Viaskin Peanut Patch Design
In August 2020, DBV Technologies obtained a Complete Response Letter (CRL) in reference to its Biologics License Application (BLA) for Viaskin™ Peanut (DBV712 250 µg), an investigational, non-invasive, once-daily epicutaneous patch to deal with peanut allergy in kids ages 4 to 11 years. Subsequently, DBV proposed a possible decision to a most important concern recognized by the FDA within the CRL: the necessity for patch modifications. The FDA agreed with DBV’s place {that a} modified Viaskin Peanut patch can be an acceptable strategy and shouldn’t be thought-about as a brand new product entity supplied the occlusion chamber of the present Viaskin Peanut patch and the peanut protein dose of 250 µg (roughly 1/1000 of one peanut) remained unchanged and carried out in the identical means they’d beforehand. In This fall 2021, DBV knowledgeable the FDA of its intent to provoke a pivotal Phase 3 medical examine for a modified Viaskin Peanut patch within the meant age inhabitants. This pivotal Phase 3 medical examine, known as VITESSE, options the modified Viaskin Peanut (mVP) patch. As DBV has beforehand disclosed, the mVP patch is round in form and roughly 50% bigger than the present Viaskin Peanut (cVP) patch. Importantly, the EPITOPE examine featured the cVP patch, which is sq. in form. DBV could preserve use of the cVP patch for future regulatory or BLA developments utilizing the EPITOPE information. DBV will use the mVP patch for the VITESSE examine.
About DBV Technologies
DBV Technologies is growing Viaskin™, an investigational proprietary know-how platform with broad potential functions in immunotherapy. Viaskin is predicated on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ technique 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 Company is devoted to soundly remodeling the care of meals allergic sufferers. DBV Technologies’ meals allergy symptoms packages embody ongoing medical 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 section B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (every representing one-half of one bizarre share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward–Looking Statements
This press launch could comprise forward-looking statements and estimates, together with statements relating to the therapeutic potential of Viaskin™ Peanut as a therapy for peanut-allergic kids, the potential advantages of EPIT™, DBV Technologies’ 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 primarily based on efficiency of earlier research, and are topic to identified and unknown dangers, uncertainties and different components 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 will not be guarantees or ensures and contain substantial dangers and uncertainties and could also be impacted by market situations 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 studies with the U.S. Securities and Exchange Commission (“SEC”), and future filings and studies 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 legislation, DBV Technologies undertakes no obligation to replace or revise the knowledge contained on this Press Release.
Investor Contact
Anne Pollak
DBV Technologies
+1 857-529-2363
[email protected]
Media Contact
Angela Marcucci
DBV Technologies
+1 646-842-2393
[email protected]
Viaskin and EPIT are logos of DBV Technologies.
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