Montrouge, France, November 2 (9:30 p.m. CET) 2023
DBV Technologies to Present New Data at ACAAI 2023
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The new data will be the subject of a “Late-Breaking” oral presentation detailing the 12-month interim results of the EPOPEX study, ongoing open-label phase 3 extension of the EPITOPE Viaskin™ Peanut study, carried out in young people children allergic to peanuts.
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that new clinical data on the use of Viaskin™ Peanut (DBV712) 250 μg in young children will be presented at the American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, November 9-13, 2023, in Anaheim, California.
A “Late-Breaking” oral presentation on the 12-month interim results of the EPOPEX study, the ongoing open-label phase 3 extension of the EPITOPE Viaskin™ Peanut study carried out in young children allergic to peanuts, has been accepted by the ACAAI and will be presented. The presentation will, after the meeting, be available on the DBV website at
www.dbv-technologies.com
for people who cannot attend.
This year’s meeting will also feature a “Product Theater” on the individualization of peanut allergy management: A group discussion based on concrete cases. Doctors Douglas Mack, David Stukus and Julie Wang will discuss factors that influence the management of peanut allergy, such as the use of food challenges and the effects of comorbidities, with a focus on based on various patient scenarios. “Product Theater” will take place on Saturday, November 11, from 11:35 a.m. to 1 p.m. PST in Hall C.
DBV sponsors the 32
e
annual edition of the FIT Bowl, a game show-style competition that tests the allergy, asthma and immunology knowledge of participating teams from training programs across the country. The contest will take place on Saturday, November 11, from 5:45 p.m. to 7:45 p.m. Pacific Standard Time at the Hilton Anaheim, Pacific C&D. In addition, DBV is a member of the ACAAI Corporate Council 2023, benefactor level. The company will also have a stand in the ACAAI exhibition hall from Saturday November 11 to Monday November 13.
“We are very pleased to once again have a significant presence at ACAAI this year, and to add to the growing body of data further validating the potential of Viaskin Peanut as a new treatment option for young children with allergy. ‘peanut’,
said
Dr. Pharis Mohideen, Medical Director of DBV Technologies
.
“Without FDA-approved treatments, young children and their families must practice avoidance, which can be stressful and significantly impact quality of life. Our goal is to complete the remaining regulatory steps towards a Biologics License Application (BLA) as quickly and efficiently as possible, in order to bring this new treatment to these patients. in need.”
Presentations of DBV:
Oral presentation “Late-Breaking”
“EPOPEX, Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-allergic Toddlers: 1-year Open-Label Extension to EPITOPE”
will be presented by Matthew Greenhawt, MD, MSc, MBA, FACAAI, of Children’s Hospital Colorado, Aurora, Colorado.
Presentation ID: LB010
Presentation date: Saturday November 11
Presentation time: 9:40 a.m. to 9:50 a.m. Pacific Standard Time
Session/location: “Late-Breaking” oral presentation – Session 1: Food allergy; Exhibition Hall C – ePoster Area – LIVE presentation on stage
Viaskin Peanut is the Company’s lead product candidate, designed to reduce the risk of allergic reactions due to accidental exposure to peanut. Viaskin Peanut is an investigational, non-invasive, once-daily epicutaneous patch that aims to deliver micrograms of peanut antigen to re-educate the immune system. The safety and effectiveness of Viaskin Peanut have not yet been established by the US Food and Drug Administration or the European Medicines Agency.
About DBV Technologies
DBV Technologies is developing Viaskin™, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, and is DBV Technologies’ method of delivering biologically active compounds to the immune system through intact skin. With this new class of non-invasive product candidates, the Company aims to safely transform the treatment of patients suffering from food allergies. DBV Technologies’ food allergy programs include ongoing clinical studies of Viaskin Peanut. DBV Technologies’ global headquarters is located in Montrouge, France, and its North American operations are based in Basking Ridge, New Jersey. The Company’s ordinary shares are traded on segment B of Euronext Paris (symbol: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing half an ordinary share) are traded on the Nasdaq Global Select Market ( symbol: DBVT).
Forward-looking statements
This press release may contain forward-looking statements and estimates, including, without limitation, statements regarding the therapeutic potential of Viaskin™ Peanut and EPIT™, and DBV’s planned regulatory and clinical efforts, including the timing and results of communications with regulatory agencies 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 neither promises nor guarantees, and involve substantial risks and uncertainties. At this stage, DBV’s product candidates have not been authorized for sale in any country. Factors that could cause actual results to differ materially from those described or projected herein include uncertainties generally related to research and development, clinical studies and related regulatory reviews and approvals. A list and a more detailed description of the risks and uncertainties that could cause actual results to differ materially from those described herein can be found in the regulatory documents filed by DBV Technologies with the Autorité des Marchés Financiers (“AMF”) ), in documents and reports filed by DBV Technologies with the US Securities and Exchange Commission (“SEC”), and in future documents and reports filed with the AMF and the SEC. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Except as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this press release.
Contact with investors
Katie Matthews
+1 (857) 529 2363
[email protected]
Media Contact
Angela Marcucci
+1 646-842-2393
Viaskin and EPIT are trademarks of DBV Technologies.
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