DBV Technologies still expects to receive an FDA decision in early August for its peanut allergy patch. But on Friday the company, which is headquartered in the southern outskirts of Paris, said it would start layoffs and scale down its drug development activities to save cash in case the radio silence it says it has received from the agency since it submitted additional data in April indicates further delays to come.
Once the company was vying with Aimmune Therapeutics (NASDAQ: AIMT) to win the first regulatory OK for a food allergy immunotherapy. In January, Aimmune’s drug, Palforzia, beat DBV’s patch to the finish line. The Brisbane, CA-based biotech’s drug is a powder made from peanut flour and was developed to desensitize patients to peanuts. The FDA approved Palforzia, which comes in capsules or packets and is meant to be taken with food, for patients from age 4 to age 17 who have a confirmed peanut allergy diagnosis.
DBV’s approach, intended for children from age 4 to age 11, uses its “Viaskin Peanut” patch to deliver compounds to the immune system epicutaneously, or through intact skin. The idea is to desensitize patients’ immune systems through exposure to small amounts of peanut protein and thereby reduce the risk of a dangerous allergic reaction spurred by accidental exposure.
Viaskin first reached the FDA’s desk in 2018. Late that year DBV withdrew the application after regulators indicated it needed to provide more information about its manufacturing procedures and quality controls.
The company resubmitted the application in the third quarter of 2019. Then, this March, the FDA asked it to submit information about the impact of adhesion on the patch’s efficacy.
The biotech, which has North American operations in Summit, NJ and New York, says it replied in April with data analyses showing the patch sticks to the skin long enough each day for most patients to experience clinical benefit. DBV also says it requested feedback from the FDA as to “the path forward”—but heard only that the fresh data were under review and that the agency’s Aug. 5 decision deadline hadn’t changed, according to the company. DBV says it has heard nothing since then about the review’s progress, an “absence of clarity” that has prompted the corporate restructuring.
The plan is intended to give the company flexibility to continue operations if the review process is extended or handle commercialization if Viaskin is approved. With the changes implemented DBV anticipates its cash and cash equivalents, which totaled €262.4 million (about $295 million) as of March 31, will fund operations “significantly beyond” the first quarter of 2021, which is how long DBV previously said its resources could last.
DBV is also studying Viaskin in a Phase 3 trial for toddlers ages 1 to 3, and reported that both doses being tested appear to be well tolerated, and after one year, providing treatment benefit. It is testing a potential treatment for milk allergy in the clinic and has a preclinical program underway for patients with egg allergies, too.
Shares of DBV (NASDAQ: DBVT) fell 14 percent to $4.66 apiece as of market close.
Image: iStock/Garrett Aitken