Montrouge, France, May 10, 2023
DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin™ Peanut in Toddlers
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The New England Journal of Medicine (NEJM) released outcomes that showed epicutaneous immunotherapy (EPITTM) with Viaskin Peanut was statistically exceptional to placebo in desensitizing kids to peanut by increasing the peanut dosage that sets off allergic signs.
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As specified in an accompanying editorial piece, these information are viewed as “very good news” for young children with peanut allergic reaction, as there are presently no authorized treatment alternatives for peanut-allergic kids under the age of 4 years.
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DBV is advancing regulative efforts for Viaskin Peanut in young children ages 1 – 3 years of ages with a verified peanut allergic reaction.
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical business, today revealed that its Phase 3 EPITOPE trial of epicutaneous immunotherapy (EPIT) with Viaskin™ Peanut in kids 1 – 3 years was released in the New England Journal of Medicine, enhancing the capacity of a brand-new food allergic reaction treatment choice for this neighborhood.
“We are thrilled to see the EPITOPE Phase 3 data published in the New England Journal of Medicine, highlighting exciting results for toddlers with peanut allergy and their loved ones,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “This publication comes shortly after receiving pre-BLA feedback from the FDA, which outlined the regulatory path for our Viaskin Peanut program in 1 – 3-year-olds. Parents and caregivers are eagerly awaiting FDA-approved treatment options for this age group. We are pleased that the NEJM has confirmed what we know to be true: the EPITOPE data represent a ‘next step towards a future with more [approved] treatments for food allergies.’.”1
Peanut allergic reaction is the most typical food allergic reaction in kids in the United States, with growing occurrence and increasing influence on clients, households, and health systems. Despite this considerable problem, there are restricted treatment alternatives for peanut allergic reaction and no FDA authorized alternatives for kids younger than 4 years of age.
Viaskin Peanut, an unique form of EPIT, has the possible to use a brand-new and advancement science that customizes a person’s underlying food allergic reaction by re-educating the body immune system to increase tolerance to irritants. As specified in the short article “the developing immune system may be particularly amenable to desensitization, which provides an important rationale for prioritizing treatments that target younger children.”
The NEJM highlights that EPIT with Viaskin Peanut, as a patch-based nonoral immunotherapy choice, has actually displayed in scientific research studies constant proof of effectiveness, safety, and high treatment adherence. The EPITOPE trial was created to permit individuals to tackle their regular day-to-day activities such as playing, bathing, or swimming, without limitations.
“I see peanut–allergic patients in my clinical practice daily. I speak with parents who are experiencing increased anxiety and a decreased quality of life due to fear of life-threatening reactions,” said Matthew Greenhawt, M.D., MBA, MSc of Children’s Hospital Colorado and lead author of the publication. “This publication shows that, if approved, the Viaskin Peanut patch has the potential to give new hope to toddlers and their families who currently have no approved treatment options and must instead rely on avoidance, which can severely impact quality of life. The EPITOPE data are a meaningful advancement in potentially offering the first-ever FDA approved treatment option for peanut-allergic toddlers.”
EPITOPE was a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate the effectiveness and safety of Viaskin Peanut in kids 1 through 3 years of age with an identified peanut allergic reaction.
After one year of treatment, Viaskin Peanut led to statistically exceptional desensitization compared to placebo, with treatment responder rates of 67.0% and 33.5%, respectively. Additionally, a shift towards less extreme food obstacle responses was seen following 12 months of treatment with Viaskin Peanut. Similar to previous research studies of Viaskin Peanut in kids, the most typical unfavorable occasions were regional application website responses, which reduced in frequency and intensity in time. Low rates of treatment-related anaphylaxis and epinephrine usage were observed. This research study showed that 12 months of day-to-day EPIT with a spot consisting of 250 µg peanut protein (1/1000th of one peanut) led to higher desensitization compared to placebo, enough to reduce the possibility of experiencing an allergy following unexpected peanut direct exposure.
Viaskin Peanut was well-tolerated by a bulk of individuals and had low discontinuations due to AEs and high compliance rates. Subjects had the ability to use the spot daily without limitations around activities for an adequate duration throughout the treatment duration to cause desensitization.
“As a parent who has raised children with food allergies and as a voice for the food allergy community, I am encouraged to see the EPITOPE trial results published by the New England Journal of Medicine,” said Kenneth Mendez, CEO of the Asthma and Allergy Foundation of America and its food allergic reaction department, Kids with Food Allergies. “Many caregivers worry about their food-allergic toddler’s accidental exposure to a food allergen. This sometimes means that they will limit their toddler from everyday activities. Caregivers need a treatment option that provides peace of mind for them and for their children. I am excited by this innovative potential treatment option and hopeful that one day, toddlers with peanut allergy will have multiple treatment options to choose from.”
To see the complete publication, accompanying QuickTake video, and editorial from the NEJM please go to the following:
Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy
Good News for Toddlers with Peanut Allergy
About EPITOPE
EPITOPE (NCT03211247) registered 413 topics (51 in Part A and 362 in Part B) in roughly 50 centers throughout North America (Canada and the United States), Europe and Australia. The EPITOPE trial was a two-part trial: Part A was created to evaluate the safety of Viaskin Peanut 100 µg and 250 µg and to figure out the greatest safe dosage, and Part B was created to evaluate the effectiveness and safety of the picked dosage. Based on the outcomes of Part A, the 250 µg dosage was picked for Part B. In Part B, topics were randomized 2:1 to receive Viaskin Peanut 250 µg or placebo.
The main endpoint was based upon a responder analysis after 12 months of treatment with the picked dosage of Viaskin Peanut. As a secondary effectiveness endpoint, cumulative reactive dosage (CRD) was likewise examined in EPITOPE to develop the overall amount of peanut protein that sets off subject responses at month 12 of active treatment versus placebo. Serological markers were likewise determined at standard, 3, 6 and 12 months in order to identify the immunological modifications in topics. There were no restrictions on activities of day-to-day living in this trial. Participants had the ability to tackle their regular lives without limitations, consisting of playing, bathing, or swimming.
Following the conclusion of EPITOPE, all qualified topics had the choice to rollover into EPOPEX, a long-lasting, open-label extension research study of Viaskin Peanut 250 µg. Now that the EPITOPE research study outcomes are openly available, topics registered in the EPOPEX research study will be unblinded to their particular treatment group in EPITOPE.
In June 2022, DBV Technologies revealed positive topline arise from EPITOPE. Viaskin Peanut showed a statistically considerable treatment impact (p<0.001), with 67.0% of topics in the Viaskin Peanut arm fulfilling the treatment responder requirements after 12 months, as compared to 33.5% of topics in the placebo arm (distinction in action rates = 33.4%; 95% CI = 22.4% – 44.5%). The EPITOPE safety outcomes were typically constant with the safety profile of Viaskin Peanut 250 μg observed in kids with peanut allergic reaction ages 4 years and older in previous scientific trials. No imbalance in the total unfavorable occasion (AE) rate was observed in the trial in between the active and placebo arms. For more info on the EPITOPE results see the DBV press release.
About DBV Technologies
DBV Technologies is establishing Viaskin™, an investigational exclusive innovation platform with broad possible applications in immunotherapy. Viaskin is based upon epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ approach of providing biologically active substances to the body immune system through undamaged skin. With this brand-new class of non-invasive item prospects, the Company is committed to securely changing the care of food allergic clients. DBV Technologies’ food allergic reactions programs consist of continuous scientific trials of Viaskin Peanut. DBV Technologies has international head office in Montrouge, France, and North American operations in Basking Ridge, NJ. The Company’s common shares are traded on sector B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing half of one common share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This news release includes positive declarations and quotes, consisting of declarations concerning DBV Technologies’ scientific advancement and regulative strategies with regard to Viaskin™ Peanut for the treatment of young children ages 1-3 years of ages, the restorative capacity of Viaskin™ Peanut as a treatment for peanut-allergic kids more broadly, the capability of any of the Company’s item prospects, if authorized, to enhance the lives of clients with food allergic reactions, styles of the Company’s prepared for scientific trials, safety research studies and HF research studies, and the timing and prepared for outcomes of interactions with regulative firms. These positive declarations and quotes are not guarantees or ensures and include considerable threats and unpredictabilities, consisting of threats intrinsic to the scientific advancement and regulative procedure, along with market conditions and other threats and unpredictabilities stated in DBV Technologies’ regulative filings with the Autorité des Marchés Financiers (“AMF”), DBV Technologies’ filings and reports with the U.S. Securities and Exchange Commission (“SEC”), and future filings and reports made with the AMF and SEC. Existing and potential financiers are warned not to position unnecessary dependence on these positive declarations and quotes, which speak just since the date hereof. Other than as needed by relevant law, DBV Technologies carries out no responsibility to update or modify the info consisted of in this Press Release.
Investor Contact
Katie Matthews
DBV Technologies
+1 857-529-2563
[email protected]
Media Contact
Angela Marcucci
DBV Technologies
+1 646-842-2393
[email protected]
Viaskin and EPIT are hallmarks of DBV Technologies.
1 Togias, Alkis, M.D., “Good News for Toddlers with Peanut Allergy.” New England Journal of Medicine. 388;19. May 11, 2023.
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