DBVT - FDA puts partial clinical hold on a DBT Technologies peanut allergy patch phase 3 trial
- French biotech DBV Technologies ( NASDAQ: DBVT ) on Wednesday said the U.S. FDA had put a partial clinical hold on its phase 3 clinical study evaluating its Viaskin Peanut patch for the treatment of peanut allergy in children aged 4 through 7.
- The FDA specified certain changes to elements of the protocol of the trial, called VITESSE.
- "Within the FDA’s communication, the modifications address design elements, including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data, to meet study objectives as well as the total number of trial participants on active treatment," DBVT said in a statement .
- The company had not yet begun the screening or recruitment of subjects in the study.
- DBVT said the partial clinical hold was only for the VITESSE trial and did not impact any other ongoing clinical studies.
- U.S.-listed shares of DBVT earlier closed +4.3% at $2.21.
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FDA puts partial clinical hold on a DBT Technologies peanut allergy patch phase 3 trial