- The FDA has lifted the partial clinical hold on DBV Technologies DBVT Phase 3 VITESSE clinical trial evaluating the modified Viaskin 250 μg peanut patch (DBV712) in peanut-allergic children aged 4 to 7 years.
- In the Partial Clinical Hold (PCH) letter, the FDA requested changes to some aspects of the VITESSE protocol, including:
- Redefining the minimum daily wear time.
- Added a statistical test to assess pavement adhesion.
- Reclassification of certain adverse events as adverse events of special interest.
- Increasing the number of study participants on active treatment.
- The FDA initiated the hold September.
- With the reversal of the PCH, the FDA confirmed that DBV has satisfactorily addressed all clinical retention issues identified in the PCH letter.
- The DBV plans to initiate a separate safety study in about 275 additional subjects. The Company does not anticipate that the additional safety study will impact its cash runway guidance.
- DBV anticipates VITESSE patient screening to begin in Q1 2023, with the last patient screened in H1 2024 and top-line results expected in H1 2025.
- Price promotion: DBVT shares are up 40.68% to $1.66 during the premarket session last Check Friday.
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