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A phase 3 pivotal safety study of Viaskin Peanut for the treatment of peanut allergic children

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Trial Profile

A phase 3 pivotal safety study of Viaskin Peanut for the treatment of peanut allergic children

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs Peanut allergy immunotherapy (Primary)
  • Indications Peanut hypersensitivity
  • Focus Registrational; Therapeutic Use
  • Acronyms COMFORT Children
  • Sponsors DBV Technologies

Most Recent Events

  • 07 Mar 2024 According to a DBV Technologies media release, company initiating two supplemental six-month safety trials, COMFORT Toddlers and COMFORT Children, as the final clinical pieces to support two separate and robust packages for our Biologics License Applications to the FDA. Number of participants on active treatment will total approximately 600 children in each of the two BLAs, 1 to 3-year-olds and 4 to 7-year-olds.
  • 07 Mar 2024 According to a DBV Technologies media release, an increase of $15.4 million in Research and Development expenses reflecting intensified Research and Development activities following the initiation of the VITESSE trial, with the first patient screened in March 2023, as well as preparations for COMFORT.
  • 07 Mar 2024 According to a DBV Technologies media release, the Company used $79.6 million of cash in operations, primarily in Research and Development, with the initiation of the VITESSE trial, with the first patient screened in March 2023, preparation activities related to COMFORT studies, as well as an increase in regulatory and pre-commercialization activities. Cash used in operations increased by $23.9 million as of December 2023 compared to December 2022.

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