DBV Technologies ($DBVT) has exited its end-of-Phase II meeting with FDA with a plan for the next steps of development of its peanut allergy vaccine. And with Aimmune Therapeutics breathing down its neck, the French biotech is keen to get its pivotal trial up and running before the end of the year.
|DBV CEO Dr. Pierre-Henri Benhamou|
Paris, France-based DBV outlined its plans this week after wrapping up meetings with regulators on both sides of Atlantic. The to-do list that emerged from these talks is topped by a Phase III trial in children aged four to 11 years old, in which DBV will enrol 260 patients at 35 sites in the U.S., Canada, Australia, Ireland and Germany. Two-thirds of participants will receive Viaskin Peanut 250 µg--a patch that delivers the allergen to the top layers of the skin to spark an immune response--and the rest will take a placebo.
The success of the trial rests on whether 12 months of treatment with Viaskin Peanut makes people better able to cope with the allergen. Notably, the primary endpoint for the Phase III trial is different than the one used in the previous study. Now, DBV will use the responder definition. For a patient with a baseline peanut protein eliciting dose (ED) of 10 mg or less going into the trial to meet the endpoint, their ED must be 300 mg or more after 12 months. The Phase IIb measured success as at least a 10-fold increase in ED over the baseline.
When DBV applied the new, tougher-to-hit endpoint to the Phase IIb data in a post-hoc analysis, it found 46.5% of patients in the treatment arm would be classed as responders, a slight dip over the original figure but still a significant improvement over the placebo. DBV will start work on trying to repeat that performance in the fourth quarter, after which it also plans to start studies looking at patients both younger and older than the four to 11-year-old demographic targeted by the first trial. Follow-up data from patients in the Phase IIb study are also due before the end of 2015.
The fresh Phase III data and follow-up Phase IIb data will go a long way to deciding whether DBV can establish a dominant position in the peanut allergy market. Since the French biotech posted Phase IIb data, it has seen Aimmune take up a position in its rearview. The Brisbane, CA-based biotech is following closely in the footsteps of DBV, having wrapped up a Phase II trial and picked up an FDA "breakthrough" status within months of its French rival achieving the same feats.
- read the release (PDF)