Dbv Technologies: New setback for clinical trials of DBV allergy patch that plummets on the stock market

(BFM Bourse) – A biotech company was forced to suspend a VITESSE Phase III trial evaluating its Viaskin peanut patch against peanut allergy after receiving a letter from the Food and Drug Administration (FDA), the US health authority.

Two weeks after the launch of the VITESSE trial (for the “Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity, and Effectiveness”), DBV Technologies should already terminate it.

This Phase III clinical trial – the last step before potential commercialization – is evaluating the biotech company’s Viaskin Peanut patch for the treatment of peanut allergy in children ages four to seven. SPEED should allow the group to apply for a Biological License (BLA) in the United States for this flagship product.

DBV Technologies began this trial earlier this month and planned to start the first patient selection process in the fourth quarter of this year and publish the first results in the first half of 2025. protocol for this study following “constructive” discussions with the Food and Drug Administration (FDA), the US health authority, on the same protocol.

Clutch in question

Ace. On Wednesday evening, the group reported receiving a partial clinical suspension letter from the FDA, forcing it to suspend VITESSE. “This partial clinical suspension concerns the VITESSE study only; this will not affect other ongoing clinical trials being conducted by DBV,” said the company, which “plans to take stock in consultation with the FDA.”

The company explains that the US health authority is describing changes that need to be made to the clinical trial protocol. “To achieve study goals, the elements of the protocol discussed in the letter relate to: statistical analysis of adherence, time of daily patch wear, methodologies for data categorization, and the total number of study participants receiving active treatment,” develops DBV Technologies.

“Previous reports from the company indicated that the FDA was focusing more on product delivery and less on compliance. On the contrary, this statement shows that the US authorities are still concerned about this last point,” said Clement Bassat, an analyst at Portzamparc.

Latency that is difficult to estimate

Shares of DBV Technologies received a warning blow on the Paris Stock Exchange. The title fell 8.4% to 3,778 euros after a loss of up to 16%, the market capitalization fell to 355 million euros. “The French market (remember that DBV is also listed in the United States) is reacting to uncertainty due to FDA requests for a potential change to the phase III trial schedule,” explains Clement Bassat.

“Bad news comes in difficult markets,” says another financial intermediary. “However, the FDA requests don’t seem too important, the question is how much delay would this cause: three months, six months, nine months? Nobody knows,” he continues.

The commitment to Viaskin Peanut has been a big topic, culminating in the first unsuccessful patch approval in the US in 2020. This oddity was another disappointment for the company after the mixed Phase III results in 2017, which hastened the title’s decline.

Julien Marion – © 2022 BFM Bourse

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