DBV Technologies has finished the patient enrollment in the Phase III study testing the use of Viaskin Peanut, for the treatment of peanut allergic children four to 11 years of age, including patients with a history of severe anaphylaxis.
Viaskin Peanut is the company`s lead product candidate, based on epicutaneous immunotherapy (EPIT), a proprietary technology platform that can deliver biologically active compounds to the immune system through the skin.
DBV Technologies said that the enrollment in the REALISE study (REAL Life Use and Safety of EPIT) exceeded initial expectations. A total of 483 patients were screened, and the company increased its initial randomization target of 335 patients to approximately 394 patients. Topline results from the REALISE trial as well as the PEPITES trial, the company`s pivotal Phase III safety and efficacy trial, are expected in the second half of 2017.
Dr. Jacqueline Pongracic, Head, Allergy and Immunology, Ann & Robert H. Lurie Children`s Hospital of Chicago, Professor of Pediatrics and Medicine, Northwestern University Feinberg School of Medicine, and Principal Investigator of REALISE, said: “We eagerly anticipate the results from this novel study, which is leading the way towards the advancement of treatment for peanut-allergic children. Importantly, we are pleased to see a study that includes patients with a history of severe anaphylaxis, a population that has historically been excluded from previous clinical trials, and represent a significant unmet clinical need.”
“The high level of interest from patients and the rapid completion of enrollment in REALISE further highlight the need for a treatment of this potentially life-threatening condition,” said Dr. Lucia Septién, Chief Medical Officer of DBV Technologies. “Following the successful enrollment in PEPITES, we are pleased to see continued excitement from patients, caregivers, and clinicians, and would like to thank them for their participation and support in our trials.”