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DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study
Châtillon, France, January 8th, 2025
DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study
EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN® Peanut patch in toddlers 1 – 3 years through 36 months
68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12
No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE
DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company’s proposed labeling approach shared with FDA
DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy & Comorbidity Conference, January 9-12, in Palm Beach, Florida
Company to host investor webcast today at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive twenty-four month results from its Open-Label Extension (OLE) Study of EPITOPE (Phase 3 trial of VIASKIN® peanut 250 µg [VP250] in toddlers ages 1 to 3 years). The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters.
DBV also announced today new Viaskin Peanut Patch efficacy and safety data based on average daily wear time from the EPITOPE study that is supportive of the Company’s VIASKIN peanut labeling strategy, proposed to FDA in June 2024. This post-hoc analysis identified subjects on Viaskin Peanut with low or high day-to-day variability in daily wear time during the first 90 days on treatment – a highly predictive marker of the average daily wear time (ADWT) during the course of the 12-month study. Subjects with low day-to-day variability in daily wear time had higher ADWT which correlated with a more robust efficacy response at 12 months.
These data are being presented in multiple poster presentations at the Eastern Food Allergy & Comorbidity Conference, which is being held January 9th through 12th, 2025, in Palm Beach, Florida.
Twenty-Four Month EPITOPE OLE Results
After completing participation (12 months) in the EPITOPE study, eligible subjects could enroll in the OLE to receive a total of 36 months of VIASKIN peanut treatment. Double-blind placebo-controlled food challenges (DBPCFC) were conducted at the end of each year of treatment with safety assessed throughout the entire OLE. Importantly, all subjects remained blinded to their treatment assignment in EPITOPE until every patient completed EPITOPE and the database was locked; therefore, the decision to enter the OLE was not biased by the unblinding of the randomized treatment.
In the EPITOPE OLE, VIASKIN Peanut data suggests further improvement through 36 months of treatment across all efficacy parameters. Key data highlights include:
266 EPITOPE participants enrolled in the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo). After three years of VP250, 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg, an increase from 64.2% at month 12 (the EPITOPE study). A similar increase was observed for participants reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12;).Those completing the DBPCFC without meeting stopping criteria increased to 68.2% at month 36 from 30.7% at month 12.
Continued reductions in DBPCFC reaction severity occurred, with 66.5% having no/mild symptoms at month 36 vs 40.2% at month 12.
No treatment-related anaphylaxis or serious treatment-related TEAEs occurred in Year 3. Local application-site reactions occurred less frequently in Year 3 vs Years 1 and 2.
In placebo-treated EPITOPE participants, outcomes after 24 months of VP250 in the OLE were consistent with 24-month results in EPITOPE VP250 participants.
“The compelling results from 36 months of Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study,” said Pharis Mohideen, Chief Medical Officer, DBV Technologies. “Notably, the data indicates that continued treatment with VIASKIN Peanut resulted in further improvement across all efficacy parameters in the second year of the OLE with no new safety signals. The data show that more than two-thirds of subjects completed the food challenge without meeting pre-defined stopping criteria, consuming the equivalent of 12-14 peanut kernels, and more than 83% reached an ED of ≥1,000mg, or the equivalent of 3-4 peanut kernels. Recall that this is a patient population that can experience devastating consequences from accidental exposure to just fractions of a peanut kernel. As we prepare to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a BLA submission, these results remind us of the tremendous potential of VIASKIN Peanut as a game changer for the peanut allergy community.”
Shared decision making for best response based on patch wear experience.
DBV also announced today new data from the Phase 3 EPITOPE study that supports the labeling approach that was proposed to FDA in June 2024. Patch wear time assessed daily by caregivers was averaged (i.e., average daily wear time or ADWT) for each subject for the first 90 days of treatment (excluding treatment initiation Days 1-28) and over the 12-month EPITOPE study.
Baseline markers of atopic disease severity such as peanut-specific IgE, skin prick test wheal size, SCORAD scores (measure of atopic dermatitis) and eliciting dose were similar between subjects with ADWT ≥ 20 hours/day and < 20 hours/day. The incidence rates and severity of local application site reactions and use of corticosteroids were also similar between groups, but the participants with ADWT < 20 hours reported markedly more scratching as a reason for patch detachments. This strongly suggests that these participants experienced lower tolerability (i.e., higher degree of “itchiness”) to peanut-induced local skin immune responses.
Data suggests that subjects with low day-to-day wear time variability (≥ 20 hours/day ADWT) had a more robust efficacy response relative to the high day-to-day variability (<20 hour/day ADWT) subjects.
Efficacy and safety data were compared for VP250 participants according to ADWT.
Key data highlights include:
167/244 (68.4%) VP250 participants had an ADWT ≥20 hours, with median ADWT (22.9 hours) similar to placebo (23.7 hours).
77/244 (31.6%) participants had an ADWT <20 hours (median: 16.7 hours).
ADWT during the first 90 days on treatment was highly predictive of ADWT over the 12-month treatment period (r=0.81).
Participants with ADWT ≥20 vs <20 hours during the first 90 days showed greater month 12 efficacy, according to EPITOPE responder criteria (75.7% vs 47.3%).
Rates of key safety outcomes of interest were numerically lower in participants with ADWT ≥20 vs <20 hours, based on treatment-related: epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%), and permanent discontinuations (9.6% vs 19.5%).
As a point of reference, overall clinical response in EPITOPE was 67.0% for patients on active, and 33.5% for patients on placebo.
“Average daily wear time is something that can easily be reported by my caregivers and patients and can be a very useful tool for me to guide shared decision making. Knowing that the ADWT during the first 90 days on treatment is highly predictive of ADWT over a full year and that these data further suggest that ADWT greater than 20 hours show a strong correlation with clinical efficacy response at 12 months will help to guide optimal use of VIASKIN peanut, if approved.”, stated Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, University of North Carolina School of Medicine, and presenting author.
Eastern Food Allergy and Comorbidity Conference - Poster Presentations
January 9-12, 2025, Palm Beach, FL
All posters will be displayed from 3:00pm ET on Thursday, January 9th through 11:45am ET on Saturday, January 11th.
“EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: Results After 3 Years of Treatment”
Presenter: Matthew Greenhawt, MD
“VP250 Average Daily Wear Time: Impact on Efficacy and Safety in the Phase 3 EPITOPE Study”
Presenter: Edwin H. Kim, MD
“Changes in Biomarkers During Epicutaneous Immunotherapy for Peanut Allergy in Toddlers”
Presenter: Edwin H. Kim, MD
“We are very pleased with the progress that DBV continues to make advancing this novel therapy through its remaining regulatory steps, and believe that, if approved, it has the potential to revolutionize the treatment of peanut allergy,” stated Eleanor Garrow-Holding, CEO, Food Allergy and Anaphylaxis Connection Team. “It is encouraging to see new data that further inform the real-world use of VIASKIN Peanut, and we are hopeful that it will soon be an available treatment option for peanut allergic patients and their caregivers.”
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, January 8th, at 5:00pm EST, to discuss these clinical updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-346-6112
International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of VIASKIN® Peanut patch and EPIT™, designs of DBV’s anticipated clinical trials, DBV’s planned
DBVT, under $4
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
Châtillon, France, December 11th, 2024
DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old
DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis
COMFORT Toddlers study on-track to initiate in 2Q 2025
Viaskin Peanut patch BLA submission for the Toddlers indication anticipated for 2H 2026
FDA confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old
Company to host investor webcast today at 5:00pm ET
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the U.S. Food and Drug Administration (FDA) that provides a clear and well-defined regulatory pathway for the Viaskin Peanut patch program in toddlers 1 – 3-years-old. The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. DBV and FDA have agreed on the key design elements for a post-marketing confirmatory study.
“DBV is pleased to have received, what we believe to be, a clear and reasonable pathway towards an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. This comes on the heels of our October 22nd press release announcing details in support of our separate Viaskin Peanut programs in 4 – 7 year-olds and in 1 – 7 year-olds in Europe,” said Daniel Tassé, Chief Executive Officer, DBV Technologies. “We believe we have decreased the regulatory pathway risk of our programs. DBV can now fully focus on executing the remaining studies that will support two distinct BLAs across age groups and an MAA in Europe. We are grateful to the Agency for its attentive collaboration as we continue to work towards introducing this novel therapy to caregivers and patients as expeditiously as possible.”
Accelerated Approval Pathway
The FDA recently issued written communication confirming an Accelerated Approval pathway for the Viaskin Peanut patch in toddlers 1 – 3-years-old. As a reminder, current FDA guidance for Accelerated Approval includes three qualifying criteria:
That the product candidate treats a serious condition
That the product candidate generally provides a meaningful advantage over available therapies
That the product candidate demonstrates an effect or an intermediate clinical endpoint that is reasonably likely to predict clinical benefit
As DBV previously announced, FDA confirmed via written communication that the Viaskin Peanut patch already met criteria one and two.
FDA and DBV have been engaged in ongoing dialogue throughout Q4 of this year regarding the intermediate clinical endpoint necessary to meet the third criterion. In the recent written communication, the FDA confirmed the efficacy data from the Company’s Phase 3 EPITOPE study can serve as an intermediate clinical endpoint. The FDA has agreed that the endpoint is reasonably likely to predict clinical benefit and will therefore fulfill the requirement for Accelerated Approval.
In preparation for commercialization, DBV made slight modifications to the Viaskin Peanut patch used in EPITOPE to increase the simplicity of application for the caregiver and provide product identification on each patch. No changes, including patch shape or size, were made to the device components that are in contact with the patient’s skin. Further, to increase the volume of patch production for future commercialization, changes needed to be made to the manufacturing process and location.
Although the intended commercial Viaskin Peanut patch is currently being used (N=304) in the ongoing 3-year Open Label Extension to EPITOPE, the collective changes to the commercial Viaskin Peanut patch were viewed by the FDA as constituting a different product relative to the clinical patch used in the EPITOPE study. The Company intends to use the commercial Viaskin Peanut patch in both the COMFORT Toddlers study and the post-marketing confirmatory study.
Post-Marketing Confirmatory Study
In the recent written communication, FDA confirmed criteria for a post-marketing confirmatory study in toddlers 1 – 3-years-old. DBV and FDA agreed that the confirmatory study will assess the effectiveness of the intended commercial Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted.
To date, the commercial patch has been used in 304 subjects with over 234,695 patient-days of therapy in the placebo crossover and the EPITOPE Open Label Extension, with no clinically relevant differences in efficacy or safety vs. the clinical patch used in the EPITOPE Phase 3 trial.
The confirmatory study will include a double-blind, placebo-controlled food challenge (DBPCFC) and will use the same statistical criteria for success (i.e., lower bound of the 95% CI > 15%) as used in the EPITOPE Phase 3 efficacy study. Adhesion data for the post-marketing confirmatory study will be collected in a similar manner relative to the COMFORT Toddlers study. The Company expects these data will further support the importance of average daily wear time in the use of the Viaskin Peanut patch as it relates to efficacy and labeling.
“When it comes to food allergy management, what works for one family, might not work for another. That is why having varied treatment options available is so incredibly important to our community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research & Education). “I’m pleased to learn that DBV’s constructive dialogue with the FDA has resulted in this Accelerated Approval guidance outlining remaining developmental steps for the Viaskin Peanut patch in toddlers with a peanut allergy. At FARE, we look forward to the possibility that one day, if approved, caregivers and families will have this exciting new treatment as an option to consider.”
COMFORT Toddlers Supplemental Safety Study
COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) study designed to generate additional safety (primary endpoint) and adhesion data of the Viaskin Peanut patch in peanut allergic toddlers 1 – 3-years old. DBV is pleased to announce that Dr. Julie Wang, MD, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn school of Medicine at Mount Sinai, will act as the Global Principal Investigator for the COMFORT Toddlers study.
“I am thrilled to assume the role of Global Principal Investigator of the COMFORT Toddlers study,” stated Dr. Julie Wang, Professor of Pediatrics, Jaffe Food Allergy Institute, Icahn school of Medicine at Mount Sinai in New York. “Viaskin Peanut, if approved, would offer a much-needed alternative treatment option for patients and caregivers. I look forward to working with the DBV team to advance this important clinical trial.”
The Company anticipates that COMFORT Toddlers will enroll approximately 480 subjects randomized 3:1 (active: placebo) at approximately 80 – 90 study centers across the U.S., Canada, Australia, and Europe. COMFORT Toddlers will be a six-month study followed by an optional 18-month open-label treatment phase, to provide 24 or 18 months of treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. Thus, the COMFORT Toddlers study will increase the total subjects exposed to the Viaskin Peanut patch for at least six-months in a controlled study to 600, as required by FDA. In total, there will be approximately 240 subjects with the clinical patch in EPITOPE and 360 with the commercial patch in COMFORT Toddlers.
As previously disclosed, DBV and FDA have aligned on a patch wear time collection methodology, analysis and study objective hierarchy in the COMFORT Toddlers study. The agreed-upon adhesion data collection methodology provides a practical approach for subjects, families, and investigators. The methodology is intended to generate sufficient data to support a BLA submission under the Accelerated Approval pathway (i.e., collecting patch adhesion data with a focus on daily wear time at relevant time points). We believe there are three positive outcomes coming out of the productive discussions with FDA:
FDA agreed that adhesion would not be a co-objective of a safety study and would be an exploratory endpoint.
Next, adhesion should be assessed in the overall totality of benefit to risk (i.e., in the context of efficacy and safety).
The third success is that we have aligned on what DBV believes is a very feasible approach to collecting adhesion data.
DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.
Biologic License Application Submission in 1 – 3 Year-Olds
There will be two Phase 3 studies in 1 – 3-year-olds using the Viaskin Peanut patch. The data generated from the studies will be used to inform a BLA submission:
Twelve months of DBPC efficacy and safety data from the previously completed Phase 3 EPITOPE study (published in the New England Journal of Medicine in May 2023), and 36 months of open-label extension data.
Six months of DBPC data generated in COMFORT Toddlers supplemental safety study.
DBV anticipates that the BLA for the Viaskin Peanut patch in toddlers 1 – 3 years-old under the Accelerated Approval program will be submitted in 2H 2026.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, Wednesday, December 11th, at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-346-6112
International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age)
DBVT 10Q March 4
DBVT new 52 week low
DBVT under $2
we are BACK!!
1.6m shares short,better cover your nuts shorties
i hope shorts get their nuts squeezed off,lol
nice ss,big moves in past
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