A skin patch developed by DBV Technologies to desensitize peanut allergy sufferers to the allergen over time has been rejected by the FDA, which says the French company needs to change its design and run another clinical trial testing the modified version if it wants the treatment reviewed again.
DBV (NASDAQ: DBVT), which has its headquarters on the outskirts of Paris and US operations in New York and Summit, NJ, said Tuesday that the FDA letter noted in addition to generating more clinical data, the company must provide more specifications about chemistry, manufacturing, and controls, after reworking the product’s design. All of those changes would be needed to support a resubmission.
Its investigational treatment, a once-daily patch called Viaskin Peanut, is intended for use by children age 4 to age 11. The agency’s central concern—whether the patches are staying on the skin long enough to ensure efficacy—is one the company first revealed the FDA had raised in March. The agency’s questions prompted the cancelation of a previously scheduled committee meeting to review the DBV submission. In June, when DBV announced a restructuring, it cited the lack of response from the agency following its submission of additional analysis regarding the adhesion issue in its rationale for the cost-cutting.
Rejection letters aren’t typically made public but DBV management told SVB Leerink analysts that the correspondence didn’t specify the data it must produce to support a resubmission. Options include conducting solely a “human factor” study to evaluate how the product would be used by children, and perhaps also additional analysis as to the drug’s likely effect and efficacy over time. Another option, the most time-consuming and costly, is a placebo-controlled Phase 3 trial, the analysts wrote in a research note. The company says it will determine which path to take following a meeting with the FDA, which it anticipates having within the next 60 days.
DBV is vying to make its treatment the second FDA-approved product for treating children diagnosed with peanut allergy. In March patients began receiving Palforzia, a peanut allergy immunotherapy developed by Brisbane, CA-based Aimmune (NASDAQ: AIMT) that was OK’d in January for children age 4 to age 17. The treatment comes in the form of capsules of ground peanut flour, intended for sprinkling over semisolid food.
“While we admit the path forward for Viaskin Peanut remains uncertain at this time, we continue to see value in DBVT’s (epicutaneous immunotherapy) approach for peanut allergy although (patients), caregivers, and physicians will have to continue to wait for an FDA-approved alternative to (Aimunne’s) Palforzia,” the analysts wrote.
The agency’s rejection puts the company even further behind Aimmune, with which it was once competing neck-and-neck to be first to market with a peanut allergy treatment. Still, even without competition, Aimmune has faced a number of hurdles in marketing its treatment, including getting physician practices and individual allergists certified to administer the treatment and implementing a safety plan that conveys the risks that come with treatment, given its association with a higher rate of systemic allergic reactions and epinephrine use in clinical trials.
DBV’s setback could delay the launch of its potential competing product, conservatively, by two years, the SVB Leerink analysts estimate. According to DBV’s first-half financial results, reported last Friday, the company has €225.9 million (about $266 million) in cash and equivalents—enough to fund its operations for at least another 12 months.
Shares in DBV fell more than 40 percent Tuesday to $2.34 apiece from $4.10 per share as of market close Monday.
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