(BFM Bourse) – The biotech company was forced to suspend the Phase III VITESSE trial evaluating its Viaskin Peanut allergy patch after receiving a letter from the Food and Drug Administration (FDA), the US health authority.
Two weeks after launching the VITESSE trial (for “Viaskin’s Peanut Immunotherapy Test to Assess Safety, Simplicity and Efficacy”), DBV Technologies has already had to stop it.
This phase III clinical trial – the final step before potential commercialization – is evaluating the biotech company’s Viaskin Peanut patch for the treatment of peanut allergies in children aged four to seven. SPEED must allow the group to submit a Biologics License Application (BLA) in the United States for this lead product.
DBV Technologies started this trial earlier this month and planned to start the process of selecting the first patient in the fourth quarter of this year and to publish the first results in the first half of 2025. DBV explained at the time that it had finalized the protocol for this study after “constructive” discussions with by the Food and Drug Administration (FDA), the US health authority, on the same protocol.
The grip in question
As. On Wednesday night, the group reported receiving a partial clinical suspension letter from the FDA, forcing it to pause VITESSE. “This partial clinical suspension only applies to the VITESSE study; it has no impact on other ongoing clinical studies conducted by DBV,” specified the company, which “plans to restock after consultation with the FDA.”
The company explains that the US Health Administration describes the changes that should be made to the clinical trial protocol. “To achieve the objectives of the study, the protocol elements discussed in the letter relate to: statistical analysis of adherence, daily patch wearing time, data categorization methodologies and the total number of study participants receiving active treatment,” DBV Technologies develops.
“The company’s previous communications suggested that the FDA focused more on product delivery and less on compliance. On the contrary, this announcement shows that the US authorities are still concerned about this last point,” notes Clément Bassat., Portzamparc analyst.
A delay that is difficult to estimate
On the Paris Stock Exchange, DBV Technologies shares suffered a warning shot. The title fell 8.4% to 3,778 euros after losing up to 16%, and its market capitalization fell to 355 million euros. “The French market (remember that DBV is also listed in the United States) is reacting to the uncertainty due to FDA requirements with potential changes to the phase III trial schedule,” explains Clément Bassat.
“It’s bad news coming in complicated markets,” says another financial intermediary. “However, the FDA requirements do not seem to be too important, the question is what kind of delay could it cause: three months, six months, nine months? No one knows,” he continues.
Viaskin Peanut adherence was a big topic culminating in the first failed patch approval in the US in 2020. This look marked another disappointment for the company after mixed results in Phase III 2017 that accelerated the title’s decline.
Julien Marion – ©2022 BFM Bourse