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DBV Technologies (Nasdaq:DBVT), a clinical-stage biopharmaceutical company, has announced a major advancement in its research efforts against peanut allergies. The company has completed patient screening for its Phase 3 trial, known as VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy), involving the modified Viaskin Peanut Patch. This trial specifically targets children aged 4 to 7 years old who are affected by peanut allergies.
Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies, expressed enthusiasm about reaching this milestone. “VITESSE is by far the largest immunotherapy clinical trial for this patient population,” he noted. Dr. Mohideen thanked the study centers for their dedication and the families of participants for their commitment to advancing food allergy treatments. He highlighted the significance of enrolling a diverse group of subjects, emphasizing the company's ongoing efforts to address the challenges faced by various communities impacted by peanut allergies.
The VITESSE trial has enrolled over 600 participants across 86 sites in multiple countries, including the U.S., Canada, Europe, the UK, and Australia. This 12-month study aims to evaluate both the safety and efficacy of the Viaskin Peanut Patch, with a randomized design of 2:1. The trial is not only the largest treatment intervention study in peanut allergies but also a critical step towards a potential Biologic License Application (BLA) submission.
DBV Technologies remains focused on the successful development of its Viaskin Peanut Patch program. With patient screening closed a month ahead of schedule, the company is optimistic about the next phases of the trial and looks forward to continued collaboration with stakeholders in the field. Dr. Mohideen concluded with an optimistic outlook for the future, underscoring the importance of this research for families affected by peanut allergies.
The completion of patient screening for the VITESSE trial marks a pivotal moment for DBV Technologies as it strives to develop innovative solutions for peanut allergies. As the company progresses towards a BLA submission, the potential impact of the Viaskin Peanut Patch on improving the quality of life for peanut-allergic children remains a beacon of hope for many families.
