David Fleischer, MD: Phase 3 Trial on Peanut Immunotherapy Patch

David Fleischer, MD, Director of the Allergy and Immunology Center at Children’s Hospital Colorado, spoke in an interview with HCPLive about the new phase 3 clinical trial known as VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety Simplicity and Efficacy).

The new trial just screened its first patient in its assessment of a modified Viaskin Peanut 250 μg patch, known as ‘DBV712,’ for children who are both peanut-allergic children and aged 4 through 7 years.

“It's a unique dose and mechanism but because of the mechanism and the dose there are different safety results, efficacy, and then practicality issues when you look at epicutaneous immunotherapy,” Fleischer explained.

As far as the mechanism of the DBV712 patch is concerned, Fleischer noted that it involves desensitization through the patient’s skin at 250 micrograms.

“It is a fixed dose,” he said. “So unlike oral immunotherapy, where you have up doses where you have to get to a certain maintenance dose, you build up your maintenance dosing at home. You start wearing the patch, and then sleep for 3 hours and then gradually at home, over several weeks, build up to 24 hours a day.”

The VITESSE study is set to use 600 participants who are randomized 2:1 active versus placebo and the trial will involve the use of around 80 trial sites in Canada, the US, Australia, and Europe.

“Basically, the protein sits on a patch, the patch is a little bit elevated on the skin,” Fleischer said. “So the body has a little bit of area underneath that perspires, and dissolves that protein. That protein is picked up by antigen-presenting cells, or allergy cells, to present it to the immune system and that goes to regional lymph nodes and transmits it that way and desensitizes that way.”

He added that due to the lack of ingestion of doses and due to the fixed dose, the safety of the product is much higher compared to oral immunotherapy.

Fleischer also explained that the primary efficacy endpoint of the phase 3 trial is the percentage of responders to treatment in the active arm compared to placebo arm at 12 months.

“In general, when you look at any of these therapies, they tend to work better when you're younger,” he added. “And that was proven in the 1 to 3-year-old study that came out in June of last year where it worked in two thirds of patients.”

To find out more about the trial and the immunotherapy product itself, view the full HCPLive interview segment above.