DBV Technologies, BioNet-Asia And Geneva University Hospitals Complete Dosing In First Cohort Of Phase I Study Of Viaskin RPT For Booster Vaccination Against Pertussis

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), the Geneva University Hospitals (HUG) and BioNet-Asia Co. Ltd today announced that in a planned interim assessment of the Phase I trial of Viaskin rPT for booster immunization against Bordetella pertussis, the independent Data and Safety Monitoring Board (DSMB) concluded that there were no safety concerns with the administration of Viaskin rPT 25 ug in the first subject cohort. Based on this review, enrollment in the trial has continued as planned, with dosing of Viaskin rPT 50 ug commencing in the second subject cohort.

The Viaskin rPT pertussis booster vaccination program intends to test the ability of DBV's needleless and adjuvant-free patch technology, Viaskin, to epicutaneously deliver two different doses of BioNet's genetically detoxified, recombinant pertussis toxin for boosting immunity against whooping cough.

In the first dosing cohort, subjects received two applications of either Viaskin rPT 25 ug or placebo. Following the DSMB's positive recommendation, a second cohort of subjects will receive two applications of Viaskin rPT 50 ug or placebo at two-week interval. This Phase I proof of concept study is being conducted under the supervision of Professor Claire-Anne Siegrist from the Clinical Research Center of HUG and is sponsored by DBV Technologies.

About the Phase I Viaskin rPT Trial

This Phase I dose-escalation, randomized, double-blind, placebo-controlled safety and immunogenicity study is assessing the safety of BioNet's genetically-detoxified recombinant pertussis toxin administered by DBV's Viaskin patches in 60 young healthy adults. Secondary endpoints will assess the patients' humoral responses elicited by Viaskin rPT 25 µg and 50 µg compared to placebo. Immune cellular responses will also be monitored as exploratory endpoints.

The trial is being conducted in the Clinical Research Center of the Geneva University Hospitals. Men and women aged 18 to 40 years who have been vaccinated during childhood against pertussis will be randomized into two cohorts of 30 subjects each. The Viaskin patches will be applied for 48 hours, with a two-week interval between applications. Four weeks after the second Viaskin application, participants will receive one dose of Boostrix® dTpa vaccine to ensure the recall of immunity against diphtheria, tetanus and the three pertussis antigens (only a single antigen will be delivered through Viaskin rPT). All subjects will be observed after each application. Local and systemic adverse events will be monitored.

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