Viaskin Peanut offers clinically significant desensitization

The results of the Phase III clinical trial on Viaskin Peanut (PEPITES), the first-ever immunotherapy test for peanut allergy, was published Friday in the Journal of the American Medical Association (JAMA). ).

The results showed that Viaskin Peanut, currently being developed by the French company DBV Technologies (Euronext: DBV), provided clinically significant desensitization to children with peanut allergies aged 4 to 11 years.

Peanut allergy is one of the most common food allergies and can cause a life-threatening reaction. However, no significant innovation has been made in recent decades in the field of immunotherapy for food allergies – patients with the option of avoidance alone.

DBV Technologies announced last week that it was again submitting Viaskin Peanut to the US Food and Drug Administration for review, in the third quarter of 2019. Last December, after discussions with the US Food and Drug Administration, the company announced that its Biologics License Application (BLA) application for Viaskin Peanut for children ages 4 to 11 has been voluntarily withdrawn from the market.

The key points of the published test have shown:

• An increase in the cumulative reactive dose (DDC), a secondary endpoint measuring threshold reactivity, was observed between Viaskin Peanut and placebo (nominal p <0.001).
• A post-hoc badysis showed that the majority of Viaskin Peanut patients had an increase in ED compared to the placebo group (62.6% of active patients versus 28% of patients in the placebo group) at 12 months.
• A post hoc badysis showed that 53.1% of participants treated with Viaskin Peanut had increased their baseline starting dose from ≤100 mg to ≥ 300 mg, compared with 19% in the placebo group. The risk badessment modeling predicted that this change could reduce the risk of reaction due to accidental exposure of> 95%.
• In PEPITES, there were no cases of severe anaphylaxis and only four of the 238 (1.7%) participants treated with Viaskin Peanut were withdrawn from the program because of adverse events that occurred during treatment – demonstrating that Viaskin Peanut could offer patients a realistic, safe and easy-to-use solution.
• However, the test did not achieve the lower threshold of an efficacy criterion.