(RTTNews) - DBV Technologies S.A (DBVT), a clinical-stage biopharmaceutical company, on Thursday announced encouraging results from its EPITOPE Phase 3 Open-Label Extension or OLE study, demonstrating continued efficacy of the VIASKIN Peanut patch in toddlers aged 1-3 years.
The data show sustained improvement in treatment benefit after 36 months of treatment.
Key findings from the study include:
-- 68.2 percent of subjects completed the oral food challenge or OFC without meeting stopping criteria, up from 30.7 percent at month 12.
-- 83.5 percent of participants reached an eliciting dose or ED of =1000 mg, compared to 64.2 percent at month 12.
-- 72.7 percent reached an ED of =2000 mg, a significant increase from 37.0 percent at month 12.
-- No treatment-related anaphylaxis or serious adverse events were reported in year three of the study.
The study also underscored the importance of patch wear time in achieving optimal efficacy. It was observed that participants who wore the patch for 20 or more hours per day showed a stronger response at 12 months.
This group exhibited a higher efficacy rate of 75.7 percent compared to those with less wear time 47.3 percent.
These findings support DBV Technologies' proposed labeling strategy for VIASKIN Peanut, which is currently under review by the FDA. These results will be presented at the Eastern Food Allergy & Comorbidity Conference in Palm Beach, Florida, from January 9-12, 2025.
Additionally, DBV Technologies is preparing to initiate the COMFORT Toddlers supplemental safety study, one of the final steps to support a Biologics License Application or BLA submission to the FDA.
Commenting on the efficacy and safety over three years of treatment, Pharis Mohideen, Chief Medical Officer at DBV Technologies said "These results reinforce the potential of VIASKIN Peanut to change the standard of care for peanut allergy, and we are excited to continue our progress as we move forward in the regulatory process."
The company had a cash and cash equivalents amounted to $46.4 million as of September 30, 2024 with cash runway into the first quarter 2025.
DBVT closed Wednesday's (Jan. 08, 2025) trading at $3.83, up 10.37%. In after-hours trading, the stock was up 6.01% at $4.06.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
