DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the company will participate in the American Academy of Allergy, Asthma, and Immunology and World Allergy Organization (AAAAI/WAO) Joint Congress, February 28-March 3, 2025, in San Diego, CA.
An oral abstract presentation by Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children’s Hospital Colorado, will describe Month 60 (M60), end-of-study efficacy and safety results from PEOPLE (the open-label extension of the 12-month, double-blind placebo-controlled, Phase 3 PEPITES study in peanut allergic children aged 4-11 years). All eligible participants who enrolled in PEOPLE were treated with VIASKIN® peanut patch for up to 60 months. Highlights from the presentation include:
Among PEOPLE participants, the percentage of treatment responders (per PEPITES criteria) increased from 39.1% at PEPITES completion to 52.9% at M36 to 73.3% at M60 (versus 88% at M60 among PEOPLE participants who completed the double-blind, placebo-controlled food challenge [DBPCFC] at M60).
Participants achieving an eliciting dose (ED) ≥1000 mg of peanut protein (the equivalent of 3-4 peanut kernels) increased from 33.3% at PEPITES completion to 48.3% at M36 to 66.7% at M60 (versus 80% at M60 among participants who completed the DBPCFC at M60).
Similarly, participants achieving an ED ≥2000 mg of peanut protein (the equivalent of 6-8 peanut kernels) increased from 2.3% at PEPITES completion to 16.1% at M36 to 33.3% at M60 (versus 40.0% at M60 among participants who completed the DBPCFC at M60).
Most TEAEs were mild to moderate local skin reactions and decreased in frequency and severity over time.
Overall mean treatment compliance at five years remained high at 93.1%.
Dr. Fleischer will also deliver a presentation on epicutaneous immunotherapy with the VIASKIN peanut patch and its clinical profile at the American Association of Allergists and Immunologists of Indian Origin (AAAII) Semi-Annual Meeting and Symposium, February 28, 2025, in San Diego, CA. The presentation will describe the immunological properties of the skin as a potent route for food allergen desensitization.
Professors Hugh Sampson, MD, of the Icahn School of Medicine at Mount Sinai (New York, NY), Helen Brough, MBBS, PhD, of Guy's and St Thomas' NHS Foundation Trust (London, UK), and moderator Douglas Mack, MSc, MD, of McMaster University (Ontario, Canada), will discuss key attributes of epicutaneous immunotherapy resulting from the skin’s unique capabilities, including controlled allergen delivery, reduced systemic exposure risk, and non-invasive, simple administration, at DBV’s non-CME Product Theater titled, “From Trigger to Tolerance: Harnessing the Skin’s Dual role with Epicutaneous Immunotherapy”. The Product Theater is scheduled for Saturday, March 1, from 10:00 a.m. to 10:30 a.m. PST in the San Diego Convention Center, Exhibit Hall A.
DBV will host a booth (#1740) in the AAAAI/WAO Joint Congress exhibit hall where attendees can learn more about epicutaneous immunotherapy with the VIASKIN® peanut patch, including the company’s ongoing and planned clinical trials in peanut-allergic children.
“The compelling five-year results from the PEPITES open label extension that are being presented at this year’s AAAAI/WAO Joint Congress help to further characterize the long-term efficacy and safety of the VIASKIN® peanut patch and add to the growing body of evidence, which demonstrates its potential as a breakthrough treatment for children suffering from peanut allergy if approved,” stated Pharis Mohideen, Chief Medical Officer of DBV. “Perhaps most notably from the PEOPLE data, treatment benefit continued to accumulate over time, with approximately 2/3 of study subjects reaching an ED of 1,000 mg or more of peanut protein, approximately equivalent to 3-4 peanut kernels, at Month 60, while the incidence of adverse events – most of which were mild-to-moderate local skin reactions – decreased in frequency and severity over that same time period.”
“The fact that treatment compliance exceeded 93% at five years gives us confidence in VIASKIN® peanut patch’s ability to become a practical new treatment option in peanut allergy upon approval. To that end, we are committed to efficiently completing the remaining studies in support of two distinct regulatory submissions – one in toddlers aged 1-3 years, and one in children aged 4-7 years,” concluded Dr. Mohideen.
DBV Presentation Details:
Oral Abstract Presentation at the AAAAI/WAO 2025 Joint Congress
“Long-Term Efficacy Results of Epicutaneous Immunotherapy With VIASKIN® Peanut Patch in Peanut-Allergic Children Aged 4-11 Years in the Phase 3 PEOPLE Study” will be presented by Dr. David Fleischer.
Session: 4605 - Latest on Treatment Outcomes in Food Allergy and Eosinophilic Esophagitis
Presentation date: March 3
Presentation time: 1:30-1:40pm PST
Presentation location: San Diego Convention Center, Upper Level, Room 11B
Presentation at the American Association of Allergists and Immunologists of Indian Origin (AAAII) Semi-Annual Meeting and Symposium
"Understanding the Skin as a Potent Route for Food Allergen Desensitization" will be presented by Dr. David Fleischer.
Presentation date: February 28
Presentation time: 7:00-7:30pm PST
Presentation location: San Diego Marriott Marquis Marina, Room Marina E
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).
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 regulatory and clinical efforts including timing and results of communications with regulatory agencies, plans and expectations regarding initiation of the confirmatory study, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, , and the ability of any of DBV’s product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV’s ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV’s regulatory filings with the French Autorité des Marchés Financiers (“AMF”), DBV’s filings and reports with the U.S. Securities and Exchange Commission (“SEC”), including in DBV’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 7, 2024, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release.
Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies.
