(Boursier.com) — DBV Technologies announces the lifting of the partial clinical hold by the FDA of the pivotal Phase 3 VITESSE clinical study.
DBV expects to begin the patient selection process in the first quarter of 2023, with the last patient to be selected in the first half of 2024 and expects the publication of the first results of the VITESSE study for the first half of 2025.
The company reaffirms that the available cash is sufficient to finance the operations until the first results of VITESSE are obtained.
In the partial clinical suspension letter, the FDA requested changes to certain elements of the VITESSE protocol so that the trial could serve as the basis of a biological license application (BLA). The FDA communication contained four protocol changes: redefinition of the minimum daily wear time, addition of a statistical test for assessment of patch adhesion, reclassification of certain adverse events as adverse events of special interest, and an increase in the number of participants in the active group.
Key design elements of VITESSE, such as inclusion criteria, primary efficacy endpoint, response criteria, efficacy assessment methodology and safety endpoints, were not impacted by the partial clinical suspension letter and have not been amended.
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