- Shares in DBV Technologies Inc. plunged in value Monday in the first trading since the French biotech disclosed its Viaskin peanut allergy treatment fell just short of its primary objective in a Phase 3 study, despite a statistically significant improvement in response over placebo.
- The company, however, plans to move ahead with a submission to the Food and Drug Administration for consideration, counting on the statistical improvement and high unmet need for allergy treatments to outweigh the endpoint miss.
- Viaskin Peanut decreased sensitivity to peanuts in 35.3% of young patients after one year of treatment, compared to 13.6% of those given placebo. However, the confidence interval for the difference in response rates between the two groups did not meet the prespecified cutoff range for the lower bound.
Imagine worrying about every birthday party your child goes to, or fearing meals out because of hidden ingredients in the food. Peanuts are among the top eight causes of serious food allergy reactions, and the prevalence of peanut or tree nut allergies tripled between 1997 and 2008, according to Food Allergy and Research Education.
First-line treatment for anaphylactic reactions resulting from exposure to peanuts is generally epinephrine auto-injectors, such as Mylan N.V.'s EpiPen or Kaleo Pharma's Auvi-Q. But the unmet need for options beyond avoidance and reactive treatment remains high.
DBV's Viaskin Peanut is a wearable patch designed to deliver biologically active compounds through intact skin, aiming to increase individual's tolerance and reduce the risk of extreme allergic reactions.
The treatment raised tolerance in a statistically higher number of patients than placebo, yet fell short of the margin needed to meet the study's goal set out by a statistical analysis plan. Also on the positive side of the ledger, results showed that individuals given DBV's treatment had higher cumulative reactive doses, a measure designed to gauge the total quantity of peanut protein which triggers patient reactions.
"The findings in this study underscore the potential of epicutaneous immunotherapy, and we continue to be encouraged by the response rate and clinically meaningful improvements in cumulative reactive dose that we observed," said Hugh Sampson, chief scientific officer at DBV, in a statement.
Adverse events were roughly similar between treatment and control arms.
Apart from DBV, other companies are also pursuing desensitization approaches. Aimmune is developing an oral immunotherapy called AR101 and has completed enrollment of its PALISADE Phase 3 study. And Astellas Pharma Inc. and Immunomic Therapeutics Inc. have secured a Fast Track designation for their potential immunotherapy ASP0892, a DNA vaccine based on LAMP-Vax technology currently in Phase 1 trials.
AnaptysBio, on the other hand, is taking a different approach with its ANB020 IL-33 antibody, which is designed to block the allergic response. Phase 2a results are expected in the fourth quarter of 2017.
These immunotherapy-based treatment approaches could add another option for people with peanut allergies besides epinephrine injections, potentially reducing the need for emergency treatment and opening up a whole new therapeutic space.