- EPITOPE OLE knowledge demonstrates continued enchancment in therapy good thing about VIASKIN® Peanut patch in toddlers 1 – 3 years via 36 months
- 68.2% of topics accomplished the oral meals problem (~12-14 peanut kernels) with out assembly stopping standards, in comparison with 30.7% at month 12
- No treatment-related anaphylaxis or severe treatment-related Therapy-Emergent Adversarial Occasions (TEAEs) occurred in yr three of EPITOPE OLE
- DBV additionally introduced day by day patch put on time knowledge from EPITOPE that’s supportive of the Firm’s proposed labeling strategy shared with FDA
- DBV to focus on these knowledge in a number of summary shows on the Jap Meals Allergy & Comorbidity Convention, January 9-12, in Palm Seaside, Florida
January 8, 2025
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, right this moment introduced constructive twenty-four month outcomes from its Open-Label Extension (OLE) Research of EPITOPE (Section 3 trial of VIASKIN® peanut 250 µg [VP250] in toddlers ages 1 to three years). The info present assist that continued therapy with VIASKIN Peanut confirmed additional enchancment via 36 months of therapy throughout all efficacy parameters.
DBV additionally introduced right this moment new Viaskin Peanut Patch efficacy and security knowledge based mostly on common day by day put on time from the EPITOPE research that’s supportive of the Firm’s VIASKIN peanut labeling technique, proposed to FDA in June 2024. This post-hoc evaluation recognized topics on Viaskin Peanut with low or excessive day-to-day variability in day by day put on time through the first 90 days on therapy – a extremely predictive marker of the common day by day put on time (ADWT) through the course of the 12-month research. Topics with low day-to-day variability in day by day put on time had greater ADWT which correlated with a extra sturdy efficacy response at 12 months.
These knowledge are being introduced in a number of poster shows on the Jap Meals Allergy & Comorbidity Convention, which is being held January 9th via 12th, 2025, in Palm Seaside, Florida.
Twenty-4 Month EPITOPE OLE Outcomes
After finishing participation (12 months) in the EPITOPE research, eligible topics might enroll within the OLE to obtain a complete of 36 months of VIASKIN peanut therapy. Double-blind placebo-controlled meals challenges (DBPCFC) have been performed on the finish of every yr of therapy with security assessed all through your entire OLE. Importantly, all topics remained blinded to their therapy project in EPITOPE till each affected person accomplished EPITOPE and the database was locked; subsequently, the choice to enter the OLE was not biased by the unblinding of the randomized therapy.
Within the EPITOPE OLE, VIASKIN Peanut knowledge suggests additional enchancment via 36 months of therapy throughout all efficacy parameters. Key knowledge highlights embody:
- 266 EPITOPE members enrolled within the OLE; 211 underwent the Month 36 DBPCFC (n=149 VP250; n=62 placebo).
- After three years of VP250, 83.5% of members reached an eliciting dose (ED) of ≥1000 mg, a rise from 64.2% at month 12 (the EPITOPE research).
- An analogous improve was noticed for members reaching an ED of ≥2000 mg (72.7% at month 36; 37.0% at month 12;).
- These finishing the DBPCFC with out assembly stopping standards elevated to 68.2% at month 36 from 30.7% at month 12.
- Continued reductions in DBPCFC response severity occurred, with 66.5% having no/delicate signs at month 36 vs 40.2% at month 12.
- No treatment-related anaphylaxis or severe treatment-related TEAEs occurred in Yr 3.
- Native application-site reactions occurred much less continuously in Yr 3 vs Years 1 and a couple of.
- In placebo-treated EPITOPE members, outcomes after 24 months of VP250 within the OLE have been in line with 24-month ends in EPITOPE VP250 members.
“The compelling outcomes from 36 months of Viaskin Peanut therapy show a continuation of the very constructive efficacy and security traits which were beforehand noticed on this research,” mentioned Pharis Mohideen, Chief Medical Officer, DBV Applied sciences. “Notably, the info signifies that continued therapy with VIASKIN Peanut resulted in additional enchancment throughout all efficacy parameters within the second yr of the OLE with no new security alerts. The info present that greater than two-thirds of topics accomplished the meals problem with out assembly pre-defined stopping standards, consuming the equal of 12-14 peanut kernels, and greater than 83% reached an ED of ≥1,000mg, or the equal of 3-4 peanut kernels. Recall that this can be a affected person inhabitants that may expertise devastating penalties from unintended publicity to simply fractions of a peanut kernel. As we put together to provoke the COMFORT Toddlers supplemental security research, one of many closing steps to assist a BLA submission, these outcomes remind us of the great potential of VIASKIN Peanut as a sport changer for the peanut allergy neighborhood.”
Shared resolution making for finest response based mostly on patch put on expertise.
DBV additionally introduced right this moment new knowledge from the Section 3 EPITOPE research that helps the labeling strategy that was proposed to FDA in June 2024. Patch put on time assessed day by day by caregivers was averaged (i.e., common day by day put on time or ADWT) for every topic for the primary 90 days of therapy (excluding therapy initiation Days 1-28) and over the 12-month EPITOPE research.
Baseline markers of atopic illness severity corresponding to peanut-specific IgE, pores and skin prick take a look at wheal dimension, SCORAD scores (measure of atopic dermatitis) and eliciting dose have been comparable between topics with ADWT ≥ 20 hours/day and < 20 hours/day. The incidence charges and severity of native utility web site reactions and use of corticosteroids have been additionally comparable between teams, however the members with ADWT < 20 hours reported markedly extra scratching as a cause for patch detachments. This strongly means that these members skilled decrease tolerability (i.e., greater diploma of “itchiness”) to peanut-induced native pores and skin immune responses.
Information means that topics with low day-to-day put on time variability (≥ 20 hours/day ADWT) had a extra sturdy efficacy response relative to the excessive day-to-day variability (<20 hour/day ADWT) topics.
Efficacy and security knowledge have been in contrast for VP250 members in accordance with ADWT.
Key knowledge highlights embody:
- 167/244 (68.4%) VP250 members had an ADWT ≥20 hours, with median ADWT (22.9 hours) just like placebo (23.7 hours).
- 77/244 (31.6%) members had an ADWT <20 hours (median: 16.7 hours).
- ADWT through the first 90 days on therapy was extremely predictive of ADWT over the 12-month therapy interval (r=0.81).
- Contributors with ADWT ≥20 vs <20 hours through the first 90 days confirmed larger month 12 efficacy, in accordance with EPITOPE responder standards (75.7% vs 47.3%).
- Charges of key security outcomes of curiosity have been numerically decrease in members with ADWT ≥20 vs <20 hours, based mostly on treatment-related: epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%), and everlasting discontinuations (9.6% vs 19.5%).
- As a degree of reference, general scientific response in EPITOPE was 67.0% for sufferers on lively, and 33.5% for sufferers on placebo.
“Common day by day put on time is one thing that may simply be reported by my caregivers and sufferers and is usually a very great tool for me to information shared resolution making. Understanding that the ADWT through the first 90 days on therapy is very predictive of ADWT over a full yr and that these knowledge additional counsel that ADWT larger than 20 hours present a robust correlation with scientific efficacy response at 12 months will assist to information optimum use of VIASKIN peanut, if authorized.”, said Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, College of North Carolina Faculty of Drugs, and presenting creator.
Jap Meals Allergy and Comorbidity Convention – Poster Displays
January 9-12, 2025, Palm Seaside, FL
All posters will likely be displayed from 3:00pm ET on Thursday, January 9th via 11:45am ET on Saturday, January 11th.
“EPOPEX, Efficacy and Security of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: Outcomes After 3 Years of Therapy”
- Presenter: Matthew Greenhawt, MD
“VP250 Common Each day Put on Time: Affect on Efficacy and Security within the Section 3 EPITOPE Research”
- Presenter: Edwin H. Kim, MD
“Modifications in Biomarkers Throughout Epicutaneous Immunotherapy for Peanut Allergy in Toddlers”
- Presenter: Edwin H. Kim, MD
“We’re very happy with the progress that DBV continues to make advancing this novel remedy via its remaining regulatory steps, and consider that, if authorized, it has the potential to revolutionize the therapy of peanut allergy,” said Eleanor Garrow-Holding, CEO, Meals Allergy and Anaphylaxis Connection Workforce. “It’s encouraging to see new knowledge that additional inform the real-world use of VIASKIN Peanut, and we’re hopeful that it’ll quickly be an accessible therapy possibility for peanut allergic sufferers and their caregivers.”
Investor Convention Name and Webcast
DBV administration will host an investor convention name and webcast right this moment, January 8th, at 5:00pm EST, to debate these scientific updates. This name is accessible through 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 accessible on the Traders & Media part of the Firm’s web site: A replay of the presentation may even be accessible 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 vital unmet medical want. DBV is at present targeted on investigating using its proprietary VIASKIN® patch know-how to handle meals allergy symptoms, that are attributable to 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 turn out 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 scientific trials of VIASKIN Peanut in peanut allergic toddlers (1 via 3 years of age) and kids (4 via 7 years of age).
DBV Applied sciences is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Firm’s unusual shares are traded on section B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Firm’s ADSs (every representing 5 unusual shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309).
For extra info, please go to www.dbv-technologies.com and interact with us on X (previously Twitter) and LinkedIn.
Ahead Wanting 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 scientific trials, DBV’s deliberate regulatory and scientific 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 Youngsters, plans and expectations with respect to the submission of BLAs to FDA, anticipated assist for the BLA submission, DBV’s expectations with respect to the Accelerated Approval pathway and every other actionable regulatory pathway, and the power of any of DBV’s product candidates, if authorized, to enhance the lives of sufferers with meals allergy symptoms. These forward-looking statements and estimates aren’t guarantees or ensures and contain substantial dangers and uncertainties. At this stage, DBV’s product candidates haven’t been approved on the market in any nation. Among the many elements that might trigger precise outcomes to vary materially from these described or projected herein embody uncertainties related typically with analysis and growth, scientific trials and associated regulatory critiques and approvals, and DBV’s capacity to efficiently execute on its finances self-discipline measures. An additional 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 may be present in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and experiences with the U.S. Securities and Alternate 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 experiences 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 legislation, DBV Applied sciences undertakes no obligation to replace or revise the data 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
