Shares in DBV Technologies were down as much as 49% on Tuesday after the company said it plans to launch a Phase III trial of a modified Viaskin Peanut patch in children. CEO Daniel Tassé said DBV "is confident that a new…pivotal study generating a robust data set is the best way to support the development of Viaskin Peanut."

The company's US filing for Viaskin Peanut to treat peanut allergy in children ages four to 11 received a complete response letter from the FDA last year. The agency had raised concerns about the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.

Seeking efficient regulatory path

According to DBV, its modified Viaskin Peanut patch is about 50% larger than the current patch, and also surpassed it in a study testing adhesion performance on healthy adult volunteers. DBV said the FDA has also requested a "sequential approach" to its development plans for Viaskin Peanut, asking to see data from an allergen uptake/transport comparability study prior to the company initiating a six-month safety and adhesion study called STAMP. However, DBV concluded that this approach would delay the regulatory process.

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Instead, the company believes "the most efficient way" to advance its peanut allergy treatment is to conduct a new placebo-controlled Phase III trial similar to the PEPITES study used to back its earlier application. "This approach [is] the most straightforward to demonstrate effectiveness, safety, and improved in vivo adhesion of the modified Viaskin Peanut system," it added. DBV plans to submit the new Phase III protocol to the FDA by the end of February 2022.

EU panel signaled 'major objection'

Meanwhile, DBV also disclosed that it will withdraw the EU marketing application for Viaskin Peanut, which was supported by results from the PEPITES trial as well. However, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has suggested that the data available to date from a single pivotal study were not sufficient to preclude a "major objection" during the review process. The major objection focused on the "limitations of the data, for example, the clinical relevance and effect size," DBV noted. However, it believes a new Phase III trial "will support a more robust path to licensure for Viaskin Peanut in the EU."

Aimmune Therapeutics' Palforzia (peanut allergen powder-dnfp) became the first approved treatment for peanut allergy in the US when the FDA cleared it last year for people ages four through 17 years. The company, which has since been acquired by Nestlé for $2.6 billion, has also garnered approval by regulators in Europe.