Montrouge, France, November 9, 2023
DBV Applied sciences Publicizes 2-12 months Outcomes from Ongoing Section 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin™ Peanut in Toddlers
- Viaskin Peanut confirmed enchancment between months 12 and 24 of remedy throughout all efficacy parameters. Notably, 81.3% of topics who accomplished the oral meals problem reached an eliciting dose of ≥1,000 mg after 24 months of remedy.
- 55.9% of topics accomplished the oral meals problem at a cumulative dose of three,444 mg with out assembly stopping standards.
- Amongst treatment-arm topics from EPITOPE, there have been no treatment-related anaphylactic or critical treatment-related opposed occasions within the second 12 months of lively remedy.
- DBV to spotlight EPOPEX leads to late-breaking oral summary presentation on the American School of Allergy, Bronchial asthma, and Immunology (ACAAI) annual assembly on Saturday, November eleventh at 9:35AM PT.
- Firm to host investor convention name and webcast at 5:00pm ET as we speak, Thursday, November ninth, to debate the outcomes.
DBV Applied sciences (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Inventory Market: DBVT), a clinical-stage biopharmaceutical firm, as we speak introduced constructive interim outcomes from its ongoing Open-Label Extension (OLE) Research of EPITOPE (Section 3 trial of Viaskin™ Peanut 250 µg [VP250] in toddlers ages 1 to three years), which is known as EPOPEX. After finishing participation within the EPITOPE research, eligible topics may enroll in EPOPEX to obtain a complete of three years of Viaskin Peanut remedy. Double-blind placebo-controlled meals challenges (DBPCFC) are performed on the finish of every 12 months of remedy with security assessed all through the complete OLE. Importantly, all topics remained blinded to their remedy 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 remedy.
Twelve-Month EPITOPE OLE Interim Outcomes:
- 244 topics have been randomized to the lively arm of EPITOPE with 208 finishing the research. 85% of eligible topics (175 of 208) entered the OLE with 95% (166 of 175) collaborating within the DBPCFC at Month 24 of Viaskin™ Peanut 250 µg (“VP250”) remedy. Comparable percentages have been noticed for the themes randomized to the placebo arm of EPITOPE: 92% of eligible topics (91 of 99) entered the OLE with 86% (78 of 91) collaborating within the DBPCFC at Month 12 of VP 250 remedy.
- The 175 and 91 topics offered within the OLE cohorts (24 months and 12 months of VP250 remedy, respectively) are a subset of the themes offered within the EPITOPE 12-month outcomes (e.g., drop-outs, incomplete DBPCFC and many others.)
- After 24 months of VP250, all efficacy parameters demonstrated a rise in remedy response relative to the corresponding EPITOPE 12-month outcomes:
- 81.3% of individuals reached an eliciting dose (ED) ≥1000 mg, or roughly 3 – 4 complete peanut kernels (64.2% in EPITOPE, n=244).
- 63.8% reached an ED ≥2000 mg (37.0% in EPITOPE, n=244).
- 55.9% accomplished the cumulative 3,444 mg DBPCFC with out assembly stopping standards (30.7% in EPITOPE, n=244).
- Utilizing the EPITOPE main endpoint definition, 83.9% of topics have been responders (67.0% in EPITOPE, n=244).
- Month-12 evaluation of the efficacy parameters within the EPITOPE topics (n=175) that entered the OLE additional demonstrates the development in remedy response following a further 12 months of remedy (24 months complete)
- At month 12, 74.7%, reached an eliciting dose (ED) ≥1000 mg relative to 81.3% at Month 24.
- At month 12, 52.4% reached an ED ≥2000 mg relative to 63.8% at Month 24.
- The proportion who accomplished the cumulative 3,444 mg DBPCFC with out assembly stopping standards was 39.5% and 55.9%, at months 12 and 24, respectively.
- Utilizing the EPITOPE main endpoint definition, 77.4% have been responders at Month 12 relative to 83.9% at month 24.
- 47.2% (17 of 36) of topics that didn’t meet EPITOPE responder standards at Month 12 did meet the responder standards at Month 24.
- No treatment-related anaphylaxis or critical treatment-related opposed occasions occurred within the second 12 months of lively remedy. The frequency of native software website response decreased within the second 12 months of remedy.
- Efficacy outcomes for topics that entered the OLE from the placebo arm of EPITOPE (i.e., crossed-over to VP250 and obtained 12-months of remedy and have been thus 2-4 years-old at VP250 remedy initiation): 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, 28.4% accomplished the DBPCFC with out assembly stopping standards and 68.0% met the EPITOPE responder definition. These outcomes have been in line with the EPITOPE VP250 arm outcomes. The protection knowledge for this group have been in line with what was noticed in EPITOPE. There was a single occasion of treatment-related anaphylaxis (after 12 months of lively remedy).
“We’re thrilled with the outcomes generated from the two-year open-label extension to the Section 3 EPITOPE trial. This OLE aimed to guage the continued efficacy, security, and tolerability of Viaskin Peanut in toddlers in a real-world setting,” said Daniel Tassé, Chief Govt Officer of DBV Applied sciences. “The information present that almost 56% of topics have been capable of eat a cumulative dose of 12 – 14 peanut kernels with out assembly the pre-defined stopping standards and greater than 81% of topics reached an eliciting dose of three – 4 peanut kernels. Recall that these are toddlers that started the research with an equal eliciting dose starting from fractions of a peanut kernel to roughly one peanut kernel. It is a promising consequence for a neighborhood of peanut allergic toddlers the place unintended publicity poses vital danger, and the present finest apply – avoidance – locations a each day burden on sufferers and households. These knowledge additional our perception that Viaskin Peanut has the potential to be the primary FDA authorised remedy for peanut allergic toddlers.”
The interim knowledge from the EPOPEX OLE shall be offered on the American School of Allergy, Bronchial asthma & Immunology (ACAAI) Annual Scientific Assembly, which is being held November 9-13, 2023, in Anaheim, CA. The information have been submitted in as a late-breaking summary and accepted for an oral summary presentation.
The presentation and summary particulars interim 12-month outcomes from topics beforehand enrolled in EPITOPE, a research of 1 12 months of epicutaneous immunotherapy with a patch containing 250 µg of peanut protein vs a placebo patch. The EPITOPE research resulted in a statistically vital remedy response vs placebo in 1-3-year-old peanut-allergic toddlers, as featured in a New England Journal of Drugs publication and editorial in Could 2023.
“These interim knowledge from the primary 12 months of follow-up from the OLE reveal that Viaskin Peanut continued to generate a remedy impact past what was noticed in EPITOPE,” said Dr. Matthew Greenhawt, Kids’s Hospital Colorado, lead writer and research investigator. “As a clinician, I’m happy that Viaskin Peanut confirmed enchancment between months 12 and 24 of remedy throughout all evaluated efficacy parameters. It’s much more encouraging that this was achieved with no new security indicators and with fewer native software website reactions in 12 months two versus 12 months one. I stay up for progressing the EPITOPE OLE to its conclusion with the objective of assessing the long-term efficacy, security, and tolerability of Viaskin Peanut.”
Late-Breaking Summary (poster presentation):
“EPOPEX, Efficacy and Security of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: 1-year Open-Label Extension to EPITOPE”
- Presenter: Matthew C. Greenhawt, MD, MSc, MBA, FACAAI, Kids’s Hospital Colorado, Anschutz Medical Campus, Aurora, CO.
- Session: Late-breaking Oral Abstracts – Session 1: Meals Allergy
- Day: Saturday, November 11
- Time: 9:35 – 10:00 AM (PT)
- Location: Exhibit Corridor C – ePoster Space – LIVE Presentation Stage
“On behalf of the meals allergy neighborhood, we’re so happy to see the outcomes from the open-label extension to the EPITOPE research” stated Eleanor Garrow-Holding, CEO, Meals Allergy and Anaphylaxis Connection Group. “Sufferers and households are eagerly awaiting FDA-approved choices which may be applicable for his or her distinctive medical wants and life-style. Viaskin Peanut, if authorised, has the potential to be an efficacious and well-tolerated remedy with a promising security profile. We stay up for DBV’s continued regulatory progress and the initiation of the COMFORT Toddlers security research to help a future BLA submission and FDA’s potential assessment of this modern product.”
Investor Convention Name and Webcast
DBV administration will host an investor convention name and webcast as we speak, November 9th, at 5:00pm EST, to debate the EPOPEX knowledge. This name is accessible through the under teleconferencing numbers and requesting the DBV Applied sciences name.
- United States: +1-844-481-2866
- Worldwide: +1-412-317-1859
A stay webcast of the decision shall be obtainable on the Buyers & Media part of the Firm’s web site: A replay of the presentation may even be obtainable on DBV’s web site after the occasion.
About DBV Applied sciences
DBV Applied sciences is creating Viaskin™, an investigational proprietary expertise platform with broad potential functions in immunotherapy. Viaskin is predicated on epicutaneous immunotherapy, or EPIT™, and is DBV Applied sciences’ technique of delivering biologically lively 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 allergy symptoms applications embrace ongoing medical trials of Viaskin Peanut. DBV Applied sciences has international headquarters in Montrouge, France, and North American operations in Basking Ridge, NJ. The Firm’s abnormal 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 abnormal share) are traded on the Nasdaq International Choose Market (Ticker: DBVT).
Ahead Wanting Statements
This press launch might include forward-looking statements and estimates, together with, however not restricted to, statements relating to the therapeutic potential of Viaskin™ Peanut and EPIT™ and DBV’s deliberate regulatory and medical efforts together with timing and outcomes of communications with regulatory companies, and the flexibility of any of DBV’s product candidates, if authorised, 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 might trigger precise outcomes to vary materially from these described or venture herein embrace uncertainties related typically with analysis and improvement, medical trials and associated regulatory evaluations and approvals. An additional listing and outline of dangers and uncertainties that might trigger precise outcomes to vary materially from these set forth herein will be present 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 Change Fee (“SEC”), and future filings and stories made with the AMF and SEC. Present and potential traders are cautioned to not place undue reliance on these forward-looking statements and estimates, which converse solely as of the date hereof. Apart from as required by relevant legislation, DBV Applied sciences undertakes no obligation to replace or revise the data contained on this Press Launch.
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