DBV Technologies says Phase III Realise trial met primary objective - InvestingChannel

DBV Technologies says Phase III Realise trial met primary objective

DBV Technologies announced “positive” topline results from the Phase III Realise trial. The double-blinded period compared the safety of treatment with Viaskin Peanut versus placebo for six months. Patients who completed the blinded portion of the study will continue to receive active treatment for up to 36 months during an open-label extension. The Realise trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events, DBV said. Based on preliminary analysis, a similar safety profile was observed in all patients included in the trial, regardless of history of severe anaphylaxis. The safety data reported complete the FDA safety database requirement for the Viaskin Peanut program in children four to 11 years of age. Results from this study, in addition to data from the Pepites Phase III efficacy and safety trial, will form the basis for planned regulatory discussions in the United States, Europe and other countries for use of Viaskin Peanut in this patient population, the company added. Results from this trial were comparable with outcomes from previous studies of Viaskin Peanut 250 mcg. The most commonly reported adverse events were local application site reactions, that were mostly mild and moderate in nature. No imbalance in serious adverse events was observed in the trial, with three cases in three subjects in the active arm, and two cases in two subjects in the placebo arm; one case in one subject in the active arm was qualified by the investigator as moderate anaphylaxis probably related to treatment. The patient responded to standard outpatient therapy. In the six-month blinded period, the discontinuation rate was 2.5%, with a 1.0% dropout related to adverse events. Mean patient compliance was above 95%. 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: “As more patients are treated with Viaskin Peanut in clinical trials, our understanding of this novel immunotherapy has deepened. In REALISE, we have observed that using the skin to activate the immune system of these patients resulted in a favorable safety and tolerability profile, likely contributing to the high compliance rate maintained throughout the blinded portion of the trial. The medical community has been eagerly anticipating a treatment that could be effective in real-life, and I am excited to have been part of this groundbreaking clinical program, which may bring us one step closer to meeting patients’ needs.”