Benzinga -
- The FDA has lifted the partial clinical hold on DBV Technologies (NASDAQ: DBVT) VITESSE Phase 3 clinical trial that will evaluate the modified Viaskin Peanut 250 μg patch (DBV712) in peanut-allergic children ages 4 to 7 years.
- In the Partial Clinical Hold (PCH) letter, the FDA requested changes to some aspects of the VITESSE protocol, including:
- Redefinition of the minimal daily wear time.
- Addition of a statistical test for the patch adhesion assessment.
- Reclassification of certain adverse events to adverse events of special interest.
- Increase in the number of trial participants on active treatment.
- The FDA initiated the hold in September.
- In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter.
- DBV plans to initiate a separate safety study in approximately 275 additional subjects. The company does not expect the additional safety study to impact its cash runway guidance.
- DBV anticipates initiating VITESSE patient screening in the first quarter of 2023, with the last patient screened in 1H 2024 and topline results anticipated in 1H 2025.
- Price Action: DBVT shares are up 40.68% at $1.66 during the premarket session on the last check Friday.