- DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old
- BLA submission beneath Accelerated Approval is topic to completion of a six-month supplemental security research in toddlers to be initiated in Q2 2025
- VITESSE Section 3 research evaluating the Viaskin Peanut patch in youngsters ages 4 – 7 years-old exceeded enrollment objectives; Topline outcomes on monitor for 4Q 2025
- European Medicines Company (EMA) scientific recommendation confirms registration path for a Advertising Authorization Utility (MAA) with the modified Viaskin peanut patch for a 1 – 7 year-old indication in Europe
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, as we speak introduced optimistic regulatory updates for the Viaskin Peanut patch in america and Europe. DBV has agreed to steering offered by the U.S. Meals and Drug Administration (FDA) on a pathway beneath the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has additionally obtained scientific recommendation from the EMA on a 1 – 7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval steering offered by the FDA by way of submission of a gathering request.
“Our settlement with FDA steering on a path in direction of Accelerated Approval for the Viaskin Peanut patch in 1 – 3 year-olds represents a major step ahead in getting this novel therapy to sufferers,” stated Daniel Tasse, Chief Govt Officer, DBV Applied sciences. “I’m happy that the FDA acknowledges the pressing unmet medical want that exists for this younger affected person inhabitants. We’re additionally very happy with the scientific recommendation obtained from EMA – one patch in peanut allergic youngsters in 1 – 7 year-olds, topic to a security research with our modified patch in toddlers 1 – 3 years-old.”
Viaskin Peanut Patch in Toddlers 1 – 3 Years
Accelerated Approval Pathway
FDA steering for Accelerated Approval embody three qualifying standards: 1) that the product treats a severe situation, 2) that the product candidate typically supplies a significant benefit over obtainable therapies, and three) that the product candidate demonstrates an impact on an intermediate medical endpoint that’s moderately prone to predict medical profit.
FDA confirmed that DBV has met criterion 1 and a couple of. Relating to criterion 3, FDA has offered steering and suggestion relating to the intermediate medical endpoint, which DBV has agreed to in casual discussions with the FDA. DBV intends to formalize the Accelerated Approval steering offered by FDA by way of submission of a gathering request to substantiate the final parts of the 2 research parts: the COMFORT Toddlers security research, to be accomplished earlier than BLA submission, and the confirmatory effectiveness research, together with the third Accelerated Approval criterion relating to the intermediate medical endpoint. DBV expects that the confirmatory research will likely be initiated by the point of BLA submission and would run in parallel to commercialization in america, if Viaskin Peanut is accepted.
COMFORT Toddlers
DBV is happy to have aligned with FDA on a put on time assortment methodology in COMFORT Toddlers that gives a sensible method for topics and households, is meant to generate adequate knowledge to assist a BLA submission, and locations put on time into a suitable medical hierarchy relative to different research endpoints. DBV has initiated research start-up actions and plans to display screen the primary topic within the second quarter of 2025. The corporate anticipates enrolling roughly 300 – 350 topics on lively therapy into the protection research, which might deliver the whole Viaskin Peanut patch security database in toddlers to roughly 600 topics, according to prior FDA steering.
With this path ahead, the BLA submission for Viaskin Peanut patch in 1 – 3 year-olds beneath the Accelerated Approval program is anticipated to be supported by:
- Optimistic efficacy and security knowledge from DBV’s beforehand accomplished EPITOPE Section 3 Research; and
- Further security knowledge generated in COMFORT Toddlers supplemental security research to be initiated in 2Q 2025.
“DBV’s Viaskin Peanut patch has the potential to considerably enhance the lives of peanut allergic toddlers and their caregivers,” said Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Youngsters’s Hospital Colorado. “With few accepted therapy choices for this affected person inhabitants – the age vary through which most younger persons are initially identified with peanut allergy – the Viaskin Peanut patch has the potential to be a recreation changer within the meals allergy group, and I sit up for having the chance to include it into my very own follow, if accepted.”
Put up-Advertising Confirmatory Research
DBV and FDA are basically settlement that the confirmatory research might want to show the effectiveness of the Viaskin Peanut patch and can must be initiated on the time that the BLA is submitted. DBV will prioritize initiation of the COMFORT Toddlers security research to allow the BLA submission.
“We’re inspired to study that FDA has heard the voices of the meals allergy group,” stated Sung Poblete, PhD, RN, CEO of FARE (Meals Allergy Analysis and Schooling). “This hopeful development within the therapy of peanut allergic toddlers has the potential to make a optimistic affect on the thousands and thousands of households which can be urgently awaiting modern therapy choices, and the confirmatory research will definitely add to the wealthy knowledge that has been compiled on this necessary illness house. We stand by DBV of their efforts to advance Viaskin and sit up for representing the affected person perspective.”
Regulatory Historical past of the Viaskin Peanut Patch in Toddlers 1 – 3
DBV and the FDA have been engaged in ongoing dialogue relating to the COMFORT Toddlers supplemental security research in 1 – 3 year-olds with a peanut allergy. The main target of continued exchanges has been on patch adhesion, particularly:
- The hierarchy of an adhesion evaluation inside the COMFORT Toddlers research (FDA requesting that or not it’s a research goal vs. exploratory evaluation);
- The sufficiency of adhesion knowledge collected in the course of the EPITOPE research to totally characterize day by day patch adhesion period (put on time) given the EPITOPE adhesion knowledge assortment methodology, and, conversely, the gathering methodology required to generate adequate adhesion knowledge to tell the Viaskin label in future research; and
- The medical relevance and regulatory use of adhesion knowledge collected in a research that doesn’t embody an efficacy evaluation.
DBV’s proposed labeling answer, submitted to the FDA on June 28, 2024, grew to become vital in exploring with the FDA, sensible options to linking adhesion, efficacy and security to greatest inform the label. These fruitful discussions have led to what DBV believes to be an actionable regulatory pathway.
Viaskin Peanut Patch in Youngsters 4 – 7
In September 2024, DBV introduced that affected person screening had been accomplished for the Section 3 efficacy trial of the Viaskin Peanut patch in peanut allergic youngsters ages 4 – 7 years-old (VITESSE). A complete of 654 topics had been enrolled, and DBV anticipates topline knowledge within the fourth quarter of 2025.
The COMFORT Youngsters security research is predicted to be initiated within the second quarter of 2025. This research plans to enroll roughly 250 topics to lift the whole variety of 4 – 7 year-olds on lively therapy throughout the event program to roughly 600, according to prior FDA steering. These two research will represent the core research for a BLA submission in 4 – 7 year-olds.
EMA Regulatory Replace
DBV sought scientific recommendation from the EMA relating to the parts of a MAA for the Viaskin Peanut patch. Earlier recommendation obtained from two native nation regulatory well being authorities indicated a possible path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA lately confirmed via scientific recommendation that the finished EPITOPE research in 1 – 3 year-olds, and a optimistic VITESSE research in 4 – 7 year-olds, might represent an MAA submission for a 1 – 7 year-old indication for peanut allergy sufferers utilizing the modified patch, together with a brand new security research in 1 – 3 year-olds with the modified patch. Timing for the initiation of this new security research to fulfill the necessary EU market is at the moment being deliberate.
The newest European Academy of Allergy & Scientific Immunology (EAACI) draft Pointers on the Administration of IgE-mediated Meals Allergy has the next suggestion: “In youngsters and adolescents with IgE-mediated peanut allergy, peanut epicutaneous immunotherapy is recommended to realize desensitization, if obtainable.” This suggestion additional helps the potential medical advantage of the Viaskin Peanut Patch, if accepted, in Europe and the unmet medical want.
Monetary Replace
Primarily based upon preliminary estimates and data obtainable to the Firm as of the date of this announcement, DBV’s money and money equivalents quantity to $46.4 million as of September 30, 2024, in comparison with $66.2 million as of June 30, 2024, a internet lower by $19.8 million comprising :
- $22.5 million of internet money stream utilized in working actions, primarily exterior clinical-related bills notably progress on affected person enrollment in VITESSE Section 3 medical trial, Regulatory and Medical actions in addition to Manufacturing Operations.
- Partially offset by Analysis Tax Credit score complementary refund for years 2020 to 2022 of $3.0 million.
These preliminary monetary outcomes replicate the Firm’s estimates and are primarily based on at the moment obtainable data. The Firm’s precise monetary outcomes for the quarter ended September 30, 2024 haven’t but been finalized by administration or reviewed by the Firm’s impartial auditors. This preliminary monetary data just isn’t a complete assertion of all monetary outcomes for the quarter ended September 30, 2024. Accordingly, undue reliance shouldn’t be positioned on these preliminary monetary outcomes.
The Firm has incurred working losses and adverse money flows from operations since inception. As of the date of this announcement, the Firm’s obtainable money and money equivalents just isn’t projected to be adequate to assist its working plan for at the very least the following 12 months. As such, there may be substantial doubt relating to the Firm’s skill to proceed as a going concern. Primarily based on present operations, plans and assumptions, the Firm expects that its stability of money and money equivalents will likely be adequate to fund its operations into 1Q 2025 and intends to hunt further capital because it continues analysis and improvement efforts and prepares for the launch of Viaskin Peanut, if accepted.
Investor Convention Name and Webcast
DBV administration will host an investor convention name and webcast as we speak, October 22nd, at 5:00pm EST, to debate these regulatory updates. This name is accessible by way of the beneath teleconferencing numbers and requesting the DBV Applied sciences name.
- United States: +1-877-346-6112
- Worldwide: +1-848-280-6350
A stay webcast of the decision will likely be obtainable on the Traders & Media part of the Firm’s web site: A replay of the presentation can even be obtainable on DBV’s web site after the occasion.
About DBV Applied sciences
DBV Applied sciences is a clinical-stage biopharmaceutical firm growing therapy choices for meals allergy symptoms and different immunologic situations with important unmet medical want. DBV is at the moment targeted on investigating the usage of its proprietary Viaskin® patch expertise to deal with meals allergy symptoms, that are brought on by a hypersensitive immune response and characterised by a variety of signs various in severity from delicate to life-threatening anaphylaxis. Thousands and thousands of individuals stay with meals allergy symptoms, together with younger youngsters. 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 folks. The Firm’s meals allergy packages 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 atypical shares are traded on phase B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing one atypical share) are traded on the Nasdaq Capital Choose Market (Ticker: DBVT).
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 might include forward-looking statements and estimates, together with statements relating to DBV’s monetary situation (together with sure preliminary monetary outcomes), forecast of its money runway, 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 to formalize the Accelerated Approval steering offered by the FDA by way of submission of a gathering request, expectations relating to initiation of the confirmatory research, plans and expectations with respect to COMFORT Toddlers (together with DBV’s plan to prioritize initiation of this research), anticipated assist for the BLA submission, DBV’s expectations with respect to an actionable regulatory pathway, and the flexibility of any of DBV’s product candidates, if accepted, to enhance the lives of sufferers with meals allergy symptoms. These forward-looking statements and estimates should 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 would 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 opinions and approvals, and DBV’s skill to efficiently execute on its price range self-discipline measures. An additional record and outline of dangers and uncertainties that would trigger precise outcomes to vary materially from these set forth within the forward-looking statements on this press launch may 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 Change Fee (“SEC”), together with in DBV’s Annual Report on Type 10-Okay for the yr 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. 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. Aside from as required by relevant regulation, 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