DBV Technologies to Highlight New Long-term Data from REALISE Trial at ACAAI 2021
DBV Technologies announced it will present new long-term data from the REALISE trial at the ACAAI 2021 Annual Scientific Meeting, Nov. 4-8, 2021. The study focuses on the safety and health-related quality of life impacts of its lead product, Viaskin™ Peanut (DBV712), in children aged 4-11. An oral presentation and a poster presentation will showcase key findings from three years of data. The company aims to demonstrate the potential real-world applications of Viaskin Peanut, which targets peanut allergy treatment through a novel epicutaneous patch technology.
- Presentation of new long-term data from the REALISE trial at ACAAI 2021 indicates ongoing progress in clinical development.
- Viaskin Peanut aims to address a significant unmet medical need by potentially reducing allergic reactions in children.
- Product candidates, including Viaskin Peanut, have not yet received regulatory approval for sale, creating uncertainty.
- The press release indicates ongoing risks tied to clinical trials and regulatory processes, which could delay timelines.
Montrouge, France, November 1, 2021
DBV Technologies to Highlight New Long-term Data from REALISE Trial at ACAAI 2021
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new clinical study results on the use of Viaskin™ Peanut (DBV712) 250 μg in children will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, Nov. 4-8, 2021. Two abstracts have been accepted, including one oral presentation and one poster presentation. These presentations will be available on DBV’s website, www.dbv-technologies.com, following the conclusion of the meeting for those who are unable to attend. DBV will also host a booth in the ACAAI exhibit hall.
The data to be presented include new long-term results of the Phase 3 REALISE (REAL Life Use and Safety of EPIT™) study in children 4-11 years of age, including the safety of Viaskin Peanut over three years and potential impact on health-related quality of life (HRQL).
“These data presented at ACAAI contribute to our understanding of and excitement for the potential real-world use of Viaskin Peanut, if approved.” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “As we continue clinical development, we remain confident in the potential of Viaskin Peanut – and driven by the hope of bringing much needed treatment options to patients and their families.”
DBV is also sponsoring the 30th Annual FIT Bowl, a game show-type competition that tests the knowledge of participating teams from training programs around the country.
Viaskin Peanut is the Company’s lead product candidate designed to reduce the risk of allergic reactions due to accidental exposure to peanuts. An investigational non-invasive, once daily, epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to re-educate the immune system. Viaskin Peanut is DBV’s proprietary approach to epicutaneous immunotherapy (EPIT), a method of delivering biologically active compounds to the immune system through the skin.
DBV Abstracts:
Oral Presentation
“REALISE (Real-life Use and Safety of EPIT) Study: 3 Year Results in Peanut-Allergic Children” will be presented by Terri Brown-Whitehorn, MD, Children’s Hospital of Philadelphia, Philadelphia, PA.
- Session Code: D030
- Session Title: Distinguished Industry Oral Abstracts – Session B
- Presentation Date: Saturday, November 6, 2021
- Presentation Time: 4:33-4:43 pm CT
Poster Presentation
“REALISE (Real-life Use and Safety of EPIT) Study: Health-related Quality of Life Changes During Treatment” will be presented by Dareen Siri, MD, Midwest Allergy Sinus Asthma SC, Normal, IL.
- Abstract Number: P116
- Presentation Date: Saturday, November 6, 2021
- Presentation Time: 12:35 pm CT
- Presentation Location: Monitor 11 in the ePoster Area of the Exhibit Hall
About DBV Technologies
DBV Technologies is developing an investigational therapeutic treatment based on epicutaneous immunotherapy, or EPIT™. This potential new class of immunotherapy is designed to regularly deliver microgram amounts of allergens to the immune system through intact skin using our proprietary epicutaneous patch technology (Viaskin™). In addition to food allergies, Viaskin technology is also being investigated as a treatment option for other immunological disorders. Additional applications for the Viaskin technology, such as use as a diagnostic tool for non-IgE-mediated milk allergy or as a non-invasive method for delivering vaccines against certain diseases, are also being investigated. DBV Technologies has global headquarters in Montrouge, France, and North American operations in Summit, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin™ Peanut as a treatment for peanut-allergic children and the potential benefits of EPIT. 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, including the impact of the COVID-19 pandemic, and DBV’s ability to successfully execute on its restructuring plans. 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, 2020, filed with the SEC on March 17, 2021, 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.
Investor Contact
Anne Pollak
DBV Technologies
+1 857-529-2363
anne.pollak@dbv-technologies.com
Media Contact
Angela Marcucci
DBV Technologies
+1 646-842-2393
angela.marcucci@dbv-technologies.com
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