DBVT - DBV stock soars 30% as FDA lifts partial hold on phase 3 trial of peanut allergy patch

DBV Technologies ( NASDAQ: DBVT ) ( OTC:DBVTF ) said the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold on its phase 3 trial which will evaluate the modified Viaskin Peanut 250 ?g patch (DBV712) to treat children aged four years to seven years with peanut allergy.

The FDA had placed a partial clinical hold on the phase 3 study, dubbed VITESSE, in September and requested changes to certain elements of the study protocol with the intent for the trial to support a biologics license application (BLA).

The FDA had requested redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active therapy.

DBV said on Friday that the FDA confirmed that the company satisfactorily addressed all clinical hold issues identified in the Partial Clinical Hold (PCH) letter and noted that the study may proceed with the following changes included in the revised protocol.

The updated  Instructions for Use (IFU) now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.

Patch adhesion will be assessed in VITESSE and a statistical test of adhesion will be included. Four AEs will be classified as AESIs.

In addition, DBV plans to start a separate safety study in ~275 individuals, randomized 3:1 active versus placebo, so that the additional safety data generated by this six-month trial will supplement the safety data generated in VITESSE, which will enroll ~600 children, randomized 2:1 versus placebo.

This will result in a safety database consisting of ~600 children ages four to seven years treated with Viaskin Peanut, according to the company.

"Following a very productive dialogue with the FDA, we have incorporated the Agency’s modifications to VITESSE into the study protocol and look forward to initiating patient treatments," said DBV Chief Medical Officer Pharis Mohideen.

DBV noted that it does not expect the additional safety study to have an impact on its cash runway. The company noted that cash on-hand is sufficient to fund operations through VITESSE topline data.

DBV anticipates starting VITESSE patient screening in Q1 2023 with the last patient screened in H1 2024 and topline results expected in H1 2025.

The company added that the updated protocol will be submitted to study sites for subsequent Institutional Review Boards/Ethics Committees approval.

DBVT +34.75% to $1.59 premarket Dec. 23

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