FDA slaps hold on DBV peanut allergy trial in call for protocol changes

The FDA has grounded DBV Technologies’ latest phase 3 peanut allergy clinical trial before it even had a chance to take flight. Just weeks after DBV trumpeted the finalization of the protocol, the FDA has placed a partial clinical hold on the study and requested changes to the design of the study.

DBV has suffered a series of setbacks over the past five years that have repeatedly pushed back its plans to bring a peanut allergy patch to market. The French biotech set out its plans for getting back on track late last year, revealing its intent to run a new phase 3 trial of a modified patch to meet the FDA’s request for more data. After back and forth with the agency, DBV announced the initiation of the trial two weeks ago. 

The afterglow of the finalization of the VITESSE protocol was short-lived. Despite DBV claiming to have had “productive exchanges” with the FDA on “key study design elements,” the agency has quickly found fault with the final protocol. 

In putting the trial on partial hold, the FDA identified a need for changes to design elements “including the statistical analysis of adhesion, minimum daily wear time and technical alignments in methods of categorizing data,” DBV said. The biotech also flagged up a request regarding the “total number of trial participants on active treatment.”

DBV had planned to screen the first patient in VITESSE by the end of the year and deliver top-line results in the first quarter of 2025. With $248 million in the bank at the last count, DBV calculated (PDF) that its cash reserves “would support operations several months beyond projected completion of Vitesse.” The biotech is yet to provide an updated timeline for starting the trial and delivering the top-line data. 

While DBV put a positive spin on the hold, noting that the feedback is “specific, clear and arrived prior to enrollment,” the biotech’s beleaguered investors sent the stock down 12% to below $2 a share ahead of the market opening in the U.S. The stock has fallen 95% over the past five years.   

DBV was once a front-runner in the race to bring a treatment for peanut allergies to market, duking it out with Aimmune Therapeutics. The first setback came in 2017, when DBV’s candidate failed a phase 3 trial. DBV forged ahead anyway, filing for FDA approval in 2018 only to swiftly pull the application. DBV tried again in 2019—and received a complete response letter for its troubles.