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DBV Begins Part 3 Examine of Redesigned Viaskin Peanut Patch in Youngsters Ages 4-7


DBV Applied sciences — a biopharma firm based mostly in Montrouge, France —introduced the initiation of a brand new section 3 medical research of their Viaskin® Peanut patch remedy designed to desensitize sufferers with peanut allergy.

The immunotherapy candidate works by exposing sufferers to minute portions of peanut allergen over time through a patch worn on the pores and skin.

Again in October 2019, DBV submitted their Biologics License Utility (BLA) to the Meals and Drug Administration (FDA) to market Viaskin Peanut immunotherapy for kids ages 4-11 within the US. However in March 2020 after performing their overview, the FDA raised questions concerning the skill of the patch to stick to the pores and skin. This finally despatched DBV again to the drafting board to revamp the patch to handle the FDA’s considerations.

In June, DBV introduced constructive topline outcomes from a section 3 medical trial in toddlers 1-3 years of age. Final week, DBV issued a press launch saying they had been initiating a section 3 research to judge the redesigned Viaskin Peanut patch in sufferers 4-7 years of age.

Right here follows the press launch in its entirety.

Montrouge, France, September 7, 2022

DBV Applied sciences Declares Initiation of Part 3 Examine (VITESSE) Utilizing the Modified Viaskin Peanut Patch in Peanut -Allergic Youngsters Ages 4 to 7 Years

  • DBV has finalized the VITESSE protocol after productive exchanges with the U.S. Meals and Drug Administration (FDA) regarding key research design components
  • DBV expects to display screen the primary affected person in This autumn 2022 and anticipates topline outcomes for the VITESSE research to learn out in Q1 2025
  • The VITESSE protocol has been submitted to check websites for subsequent Institutional Evaluate Board (IRB)/Ethics Committee (EC) approval
  • The Firm will host a convention name at 5:30 p.m. ET (11:30 p.m. CEST) on Wednesday, September 7, 2022

DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, immediately introduced the initiation of the Part 3 research, VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), utilizing the modified Viaskin™ Peanut Patch, in peanut-allergic youngsters ages 4 to 7 years. The research was initiated following productive exchanges with the U.S. Meals and Drug Administration (FDA). The protocol has been submitted to check websites for subsequent Institutional Evaluate Boards (IRB)/Ethics Committees (EC) approval.

DBV expects to enroll 600 topics for participation within the VITESSE research, randomized 2:1 energetic to placebo. The primary affected person screened is anticipated in This autumn 2022 with the final affected person screened by year-end 2023. The Firm anticipates that the topline outcomes will learn out in Q1 2025. Dr. David Fleischer, Colorado Youngsters’s Hospital, will act because the Principal Investigator for the VITESSE research, which is able to contain roughly 80 research websites throughout the U.S., Canada, Australia, Europe and the U.Ok.

During the last 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 doubtlessly assist a future BLA submission.

Following productive discussions, the FDA granted DBV a Sort C assembly in Could 2022 to align on the VITESSE research. The research protocol was submitted to the FDA as a part of the Sort C briefing supplies. Subsequent exchanges between DBV and the FDA ensued to align on vital design components and endpoints, and these had been included within the closing protocol that was despatched to check websites.

“We’re happy to have initiated the VITESSE research,” mentioned Daniel Tassé, Chief Government Officer of DBV Applied sciences. “DBV has engaged in a extremely collaborative course of with the FDA during the last a number of months, and we’re happy with the ultimate protocol that has been shared with research websites. As I’ve mentioned earlier than, VITESSE means pace in French, and we proceed to imagine that this method is the quickest technique to carry Viaskin Peanut to peanut-allergic youngsters on this age group. Our future sufferers are relying on us, and we’ll proceed to actively work in the direction of bringing this novel, revolutionary remedy to the market.”

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 youngsters ages 4 to 7 years. The first efficacy endpoint is the proportion of therapy responders within the energetic versus placebo arms at month 12. The first efficacy evaluation contains the success criterion of the decrease sure of the arrogance interval of the distinction in responder charges between energetic and placebo teams being higher than or equal to fifteen%.

DBV outlined the VITESSE inclusion standards to handle 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 youngster from a response to an unintended allergen ingestion and forestall meals allergy from negatively impacting their youngster’s high quality of life. Caregivers cite stressors particular to youthful age teams, equivalent to a toddler’s incapability to self-manage their meals allergy, transitions to extra impartial environments equivalent to daycare and faculty, and a notion that meals allergy will more and more impression their youngster’s high quality of life. 

The choice 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 youngsters ages 4 to 11 years, and consideration of the just lately introduced EPITOPE (EPIT in TOddlers with PEanut Allergy) information in toddlers ages 1 to three years. The VITESSE age inclusion criterion aligns the protocol with an age cohort of peanut allergy sufferers who’ve demonstrated a better response fee in earlier peanut allergy therapy research.

We sit up for sustaining our work with the FDA, website investigators and different key stakeholders as we advance VITESSE,” mentioned Dr. Pharis Mohideen, Chief Medical Officer of DBV Applied sciences. “We really feel assured that the VITESSE protocol incorporates all key learnings from our earlier Viaskin Peanut research and advances within the meals allergy therapy panorama. We imagine that caregivers are motivated to hunt therapy choices on this affected person inhabitants.

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 likely 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.

Whereas adhesion of the modified Viaskin Peanut patch will likely be assessed in VITESSE, there is no such thing as a patch detachment endpoint included within the research parameters. In VITESSE, adhesion will likely be assessed to affirm the modified Viaskin Peanut patch offers ample supply of the allergen to the immune system over the course of 12 months. These information will likely be used to assist the Sponsor-defined important system requirement as per FDA system rules for optimum product efficiency. Accordingly, the Directions for Use (IFU) for the modified patch will direct caregivers to use one patch at roughly the identical time every day, following removing of yesterday’s patch. The IFU outlines that Viaskin Peanut 250 µg is to be worn for as near a full day as potential with a minimal every day put on time of at the least 12 hours every day.

Individuals will apply the modified patch (both Viaskin Peanut 250 µg or a placebo) every day for a interval of 12 months. The utmost research period per topic is 58 weeks: a four-week screening interval, a 12-month therapy interval and a two-week follow-up interval. In the course of the screening interval, topics will bear an preliminary screening go to with evaluation for eligibility in accordance with peanut pores and skin prick take a look at (SPT) and serum peanut IgE. These assembly these standards will proceed to a peanut DBPCFC to verify their peanut allergy and set up an entry peanut ED. The entry DBPCFC will likely be 1 mg peanut protein, and can escalate as much as a highest single dose of 100 mg peanut protein. Topics 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 likely be carried out, with a beginning dose of three mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein in accordance with the next schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints embody adjustments in Cumulative Reactive Dose, ED and severity of allergic response at baseline and month 12 meals problem. VITESSE can even consider the protection of the modified Viaskin Peanut patch based mostly 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 research 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 likely be accessible on the Traders & Media part of the Firm’s web site: A replay of the presentation can even be accessible on DBV’s web site after the occasion.

In regards to the Viaskin Peanut Patch Design
In August 2020, DBV Applied sciences acquired a Full Response Letter (CRL) in reference to its Biologics License Utility (BLA) for Viaskin™ Peanut (DBV712 250 µg), an investigational, non-invasive, once-daily epicutaneous patch to deal with peanut allergy in youngsters ages 4 to 11 years. Subsequently, DBV proposed a possible decision to a fundamental 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 applicable method 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 1 peanut) remained unchanged and carried out in the identical means that they had beforehand. In This autumn 2021, DBV knowledgeable the FDA of its intent to provoke a pivotal Part 3 medical research for a modified Viaskin Peanut patch within the supposed age inhabitants. This pivotal Part 3 medical research, 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 research featured the cVP patch, which is sq. in form. DBV could keep use of the cVP patch for future regulatory or BLA developments utilizing the EPITOPE information. DBV will use the mVP patch for the VITESSE research.

About DBV Applied sciences
DBV Applied sciences is growing Viaskin™, an investigational proprietary know-how platform with broad potential purposes in immunotherapy. Viaskin is predicated on epicutaneous immunotherapy, or EPIT™, and is DBV Applied sciences’ methodology 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 Firm is devoted to soundly remodeling the care of meals allergic sufferers. DBV Applied sciences’ meals allergic reactions applications embody ongoing medical trials of Viaskin Peanut. DBV Applied sciences has world headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Firm’s odd shares are traded on section 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).

AheadTrying Statements
This press launch could include forward-looking statements and estimates, together with statements relating to the therapeutic potential of Viaskin™ Peanut as a therapy for peanut-allergic youngsters, 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 on efficiency of earlier research, and are topic to identified and unknown dangers, uncertainties and different elements 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 situations 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 stories with the U.S. Securities and Alternate Fee (“SEC”), and future filings and stories made with the AMF and SEC.  Current and potential traders 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 legislation, DBV Applied sciences undertakes no obligation to replace or revise the knowledge contained on this Press Launch.

Investor Contact
Anne Pollak
DBV Applied sciences
+1 857-529-2363

Media Contact
Angela Marcucci
DBV Applied sciences
+1 646-842-2393

Viaskin and EPIT are logos of DBV Applied sciences.

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