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In this interview segment, Fleischer further described some of the key points about the peanut immunotherapy patch, DBV712, and the product’s phase 3 VITESSE trial.
During this HCPLive interview segment, David Fleischder, MD, spoke about his hopes for the future of immunotherapy treatment and about other major points on the phase 3 Viaskin Peanut Immunotherapy Trial to Evaluate Safety Simplicity and Efficacy (VITESSE) trial.
Fleischer is known for his work as an investigator, as Director of the Allergy and Immunology Center and as Section Head of Allergy and Immunology at Children’s Hospital Colorado.
He first described his views on the benefits of the modified Viaskin Peanut 250 μg patch, ‘DBV712,’ designed for children who are both peanut-allergic and in the age-range of 4 - 7 years.
“It's really up to the parents, and the patients and us as advocates, to have a shared decision making process of what's best for them,” he explained. “But I do think, you know, having that safety and practicality makes it an attractive product for families.”
Fleischer pointed out that an ideal he and his team strive for is to help families with members that have allergies have more choices.
“And that's where this is, if it works,” he said, regarding the DBV712 patch. “And it's very safe and effective, we absolutely want to get this to families to be able to use to have a choice. And some may choose this and some may choose it or some may choose ongoing avoidance. Honestly, they may not want to do therapy that's everyday, because this still is a daily therapy that requires some effort.”
Nevertheless, Fleischer explained that compared to other available immunotherapies that are given daily, he believes it is a fairly easy and safe product for patients to use.
“We hope it to be what we call a positive trial and meaning that it meets all of the endpoints, but also this statistical endpoint that was not met in the first study…” he explained. “More so that it's a requirement by the (US Food and Drug Administration) to meet a certain confidence interval around the efficacy endpoint. And I think we're confident that, doing this in a younger population, we’ll reach that endpoint.”
Fleischer also added that he does not expect, having been part of the first 2 trials and seeing the data from the studies, to see any big safety signal differences.
For further information about Fleischer’s work, view the interview segment above.