- DBV and FDA aligned on key research design components for the COMFORT Toddlers research in 1 – 3 year-olds, together with research measurement and put on time assortment methodology and evaluation
- COMFORT Toddlers research on-track to provoke in 2Q 2025
- Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026
- FDA confirmed standards for post-marketing confirmatory research in toddlers 1 – 3 years-old
- Firm to host investor webcast immediately at 5:00pm ET
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, immediately introduced the profitable final result of current written and oral communication with the U.S. Meals and Drug Administration (FDA) that gives a transparent and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized steerage on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the important thing design components for a post-marketing confirmatory research.
“DBV is happy to have acquired, what we imagine to be, a transparent and affordable pathway in the direction of an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22nd press launch saying particulars in help of our separate Viaskin Peanut applications in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” mentioned Daniel Tassé, Chief Government Officer, DBV Applied sciences. “We imagine we have now decreased the regulatory pathway danger of our applications. DBV can now totally deal with executing the remaining research that may help two distinct BLAs throughout age teams and an MAA in Europe. We’re grateful to the Company for its attentive collaboration as we proceed to work in the direction of introducing this novel remedy to caregivers and sufferers as expeditiously as attainable.”
Accelerated Approval Pathway
The FDA lately issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, present FDA steerage for Accelerated Approval contains three qualifying standards:
- That the product candidate treats a severe situation
- That the product candidate typically supplies a significant benefit over out there therapies
- That the product candidate demonstrates an impact or an intermediate medical endpoint that’s fairly prone to predict medical profit
As DBV beforehand introduced, FDA confirmed through written communication that the Viaskin Peanut patch already met standards one and two.
FDA and DBV have been engaged in ongoing dialogue all through This autumn of this 12 months concerning the intermediate medical endpoint mandatory to satisfy the third criterion. Within the current written communication, the FDA confirmed the efficacy information from the Firm’s Part 3 EPITOPE research can function an intermediate medical endpoint. The FDA has agreed that the endpoint is fairly prone to predict medical profit and can due to this fact fulfill the requirement for Accelerated Approval.
In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch utilized in EPITOPE to extend the simplicity of software for the caregiver and supply product identification on every patch. No adjustments, together with patch form or measurement, had been made to the machine parts which might be involved with the affected person’s pores and skin. Additional, to extend the amount of patch manufacturing for future commercialization, adjustments wanted to be made to the manufacturing course of and placement.
Though the meant industrial Viaskin Peanut patch is at the moment getting used (N=304) within the ongoing 3-year Open Label Extension to EPITOPE, the collective adjustments to the industrial Viaskin Peanut patch had been considered by the FDA as constituting a distinct product relative to the medical patch used within the EPITOPE research. The Firm intends to make use of the industrial Viaskin Peanut patch in each the COMFORT Toddlers research and the post-marketing confirmatory research.
Publish-Advertising and marketing Confirmatory Examine
Within the current written communication, FDA confirmed standards for a post-marketing confirmatory research in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory research will assess the effectiveness of the meant industrial Viaskin Peanut patch and can must be initiated on the time that the BLA is submitted.
To this point, the industrial patch has been utilized in 304 topics with over 234,695 patient-days of remedy within the placebo crossover and the EPITOPE Open Label Extension, with no clinically related variations in efficacy or security vs. the medical patch used within the EPITOPE Part 3 trial.
The confirmatory research will embody a double-blind, placebo-controlled meals problem (DBPCFC) and can use the identical statistical standards for fulfillment (i.e., decrease sure of the 95% CI > 15%) as used within the EPITOPE Part 3 efficacy research. Adhesion information for the post-marketing confirmatory research will probably be collected in an identical method relative to the COMFORT Toddlers research. The Firm expects these information will additional help the significance of common day by day put on time in the usage of the Viaskin Peanut patch because it pertains to efficacy and labeling.
“In terms of meals allergy administration, what works for one household, may not work for an additional. That’s the reason having assorted therapy choices out there is so extremely necessary to our neighborhood,” mentioned Sung Poblete, PhD, RN, CEO of FARE (Meals Allergy Analysis & Training). “I’m happy to be taught that DBV’s constructive dialogue with the FDA has resulted on this Accelerated Approval steerage outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we stay up for the chance that at some point, if permitted, caregivers and households may have this thrilling new therapy as an choice to contemplate.”
COMFORT Toddlers Supplemental Security Examine
COMFORT Toddlers is a Part 3 double-blind, placebo-controlled (DBPC) research designed to generate further security (main endpoint) and adhesion information of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years previous. DBV is happy to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Meals Allergy Institute, the Icahn college of Medication at Mount Sinai, will act because the International Principal Investigator for the COMFORT Toddlers research.
“I’m thrilled to imagine the function of International Principal Investigator of the COMFORT Toddlers research,” acknowledged Dr. Julie Wang, Professor of Pediatrics, Jaffe Meals Allergy Institute, Icahn college of Medication at Mount Sinai in New York. “Viaskin Peanut, if permitted, would supply a much-needed various therapy choice for sufferers and caregivers. I stay up for working with the DBV group to advance this necessary medical trial.”
The Firm anticipates that COMFORT Toddlers will enroll roughly 480 topics randomized 3:1 (lively: placebo) at roughly 80 – 90 research facilities throughout the U.S., Canada, Australia, and Europe. COMFORT Toddlers will probably be a six-month research adopted by an non-obligatory 18-month open-label therapy part, to supply 24 or 18 months of therapy with the Viaskin Peanut patch for individuals randomized to the lively or placebo teams, respectively. Thus, the COMFORT Toddlers research will improve the overall topics uncovered to the Viaskin Peanut patch for not less than six-months in a managed research to 600, as required by FDA. In complete, there will probably be roughly 240 topics with the medical patch in EPITOPE and 360 with the industrial patch in COMFORT Toddlers.
As beforehand disclosed, DBV and FDA have aligned on a patch put on time assortment methodology, evaluation and research goal hierarchy within the COMFORT Toddlers research. The agreed-upon adhesion information assortment methodology supplies a sensible method for topics, households, and investigators. The methodology is meant to generate adequate information to help a BLA submission underneath the Accelerated Approval pathway (i.e., amassing patch adhesion information with a deal with day by day put on time at related time factors). We imagine there are three constructive outcomes popping out of the productive discussions with FDA:
- FDA agreed that adhesion wouldn’t be a co-objective of a security research and could be an exploratory endpoint.
- Subsequent, adhesion must be assessed within the general totality of profit to danger (i.e., within the context of efficacy and security).
- The third success is that we have now aligned on what DBV believes is a really possible method to amassing adhesion information.
DBV has initiated research start-up actions and plans to display the primary topic within the second quarter of 2025.
Biologic License Software Submission in 1 – 3 12 months-Olds
There will probably be two Part 3 research in 1 – 3-year-olds utilizing the Viaskin Peanut patch. The information generated from the research will probably be used to tell a BLA submission:
- Twelve months of DBPC efficacy and security information from the beforehand accomplished Part 3 EPITOPE research (printed within the New England Journal of Medication in Could 2023), and 36 months of open-label extension information.
- Six months of DBPC information generated in COMFORT Toddlers supplemental security research.
DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old underneath the Accelerated Approval program will probably be submitted in 2H 2026.
Investor Convention Name and Webcast
DBV administration will host an investor convention name and webcast immediately, Wednesday, December 11th, at 5:00pm EST, to debate these regulatory updates. This name is accessible through the under teleconferencing numbers and requesting the DBV Applied sciences name.
- United States: +1-877-346-6112
- Worldwide: +1-848-280-6350
A dwell webcast of the decision will probably be out there on the Buyers & Media part of the Firm’s web site: A replay of the presentation will even be out there on DBV’s web site after the occasion.
About DBV Applied sciences
DBV Applied sciences is a clinical-stage biopharmaceutical firm creating therapy choices for meals allergic reactions and different immunologic circumstances with important unmet medical want. DBV is at the moment targeted on investigating the usage of its proprietary Viaskin® patch expertise to handle meals allergic reactions, that are attributable to a hypersensitive immune response and characterised by a variety of signs various in severity from gentle to life-threatening anaphylaxis. Hundreds of thousands of individuals dwell with meals allergic reactions, together with younger kids. By way of epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram quantities of a biologically lively compound to the immune system via intact pores and skin. EPIT is a brand new class of non-invasive therapy that seeks to change a person’s underlying allergy by re-educating the immune system to grow to be desensitized to allergen by leveraging the pores and skin’s immune tolerizing properties. DBV is dedicated to reworking the care of meals allergic individuals. The Firm’s meals allergy applications embody ongoing medical trials of Viaskin Peanut in peanut allergic toddlers (1 via 3 years of age) and youngsters (4 via 7 years of age).
DBV Applied sciences is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Firm’s peculiar shares are traded on section B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing 5 peculiar shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For extra data, please go to www.dbv-technologies.com and interact with us on X (previously Twitter) and LinkedIn.
Ahead Trying Statements
This press launch could comprise forward-looking statements and estimates, together with statements concerning the therapeutic potential of Viaskin® Peanut patch and EPIT™, designs of DBV’s anticipated medical trials, DBV’s deliberate regulatory and medical efforts together with timing and outcomes of communications with regulatory businesses, plans and expectations concerning initiation of the confirmatory research, plans and expectations with respect to COMFORT Toddlers and COMFORT Kids, plans and expectations with respect to the submission of BLAs to FDA, anticipated help for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and another actionable regulatory pathway, and the flexibility of any of DBV’s product candidates, if permitted, to enhance the lives of sufferers with meals allergic reactions. These forward-looking statements and estimates usually are not guarantees or ensures and contain substantial dangers and uncertainties. At this stage, DBV’s product candidates haven’t been licensed on the market in any nation. Among the many components that might trigger precise outcomes to vary materially from these described or projected herein embody uncertainties related typically with analysis and improvement, medical trials and associated regulatory critiques and approvals, and DBV’s potential to efficiently execute on its price range self-discipline measures. An extra record and outline of dangers and uncertainties that might trigger precise outcomes to vary materially from these set forth within the forward-looking statements on this press launch could be present in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reviews with the U.S. Securities and Trade Fee (“SEC”), together with in DBV’s Annual Report on Kind 10-Okay for the 12 months ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reviews made with the AMF and SEC by DBV. Present 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. Aside from as required by relevant legislation, DBV Applied sciences undertakes no obligation to replace or revise the knowledge contained on this Press Launch.
Viaskin is a registered trademark and EPIT is a trademark of DBV Applied sciences.
Investor Contact
Katie Matthews
DBV Applied sciences
katie.matthews@dbv-technologies.com
Media Contact
Angela Marcucci
DBV Applied sciences
angela.marcucci@dbv-technologies.com
