Clinical Trials

* On September 22, 2014, DBV Technologies announced topline results for its VIPES (Viaskin Peanut’s Efficacy and Safety) phase IIb clinical trial of Viaskin Peanut in peanut allergic patients. The trial met its primary endpoint at the highest explored dose (Viaskin Peanut 250 ?g), achieving statistical significance (p=0.0108) in desensitizing a higher proportion of patients versus placebo after 12 months of Epicutaneous Immunotherapy (EPIT). Patients treated with Viaskin Peanut 250 ?g also showed statistically significant changes in measured serological markers while placebo patients did not exhibit material differences. The safety profile was confirmed across all active arms with no serious treatment-related adverse events reported, and patient compliance with daily Viaskin Peanut application was above 97%. The trial drop-out rate was 6.4%, below the 15% rate initially anticipated. Full results of efficacy and safety will presented at future scientific meetings. 

Trial responders were defined as patients who, after 12 months of treatment with Viaskin Peanut and using a double-blind, placebo controlled food challenge, started to react at a dose of peanut protein equal to or greater than 1,000 mg, or at least a 10-fold increase in the eliciting dose of peanut protein compared to baseline. As a secondary efficacy endpoint, Cumulative Reactive Dose, or CRD, was also used to establish the total quantity of peanut protein that begun triggering patient reactions at month 12 versus placebo. Serological markers were also measured as additional secondary endpoints at baseline, 3, 6, and 12 months in order to characterize the immunological changes in subjects. Overall, the 250 ?g dose showed the highest efficacy with statistical significance for these endpoints. In terms of peanut consumption and immunological changes, a consistent dose effect was observed. A total of 56 patients were randomized to the Viaskin Peanut 250 ?g dose. In this arm, 50% of patients responded, compared to 25% in the placebo group, showing statistical significance (p=0.0108). Specifically, 53.6% of children responded to treatment compared to a 19.4% response in placebo (p=0.008). Children treated with Viaskin showed a strong increase in peanut consumption, with an increase in LS mean (Least Squares Mean is a statistical model adjusted for multiple factors including both categorical, such as treatment, country and continuous covariates, such as baseline peanut dose measures allowing to better isolate solely the effect of treatment) in the change of CRD from baseline of 390.4 mg (p<0.001). Serological responses also showed treatment effect. In treated children, peanut-specific immunoglobulin E (IgE) increased over the first 6 months before decreasing toward initial levels at 12 months, while peanut-specific immunoglobulin G4 (IgG4) increased by more than 19 times over 12 months of treatment. Both biomarkers suggest a powerful desensitization effect.

- Adolescents showed a trend toward efficacy, showing a response rate of 38.9% in the active arm versus 22.2% in the corresponding placebo group. A statistically significant improvement in the adolescents’ ability to consume peanut protein was also observed, as the LS mean in change of CRD from baseline of this subgroup was 276.0 mg (p=0.047). The IgG4 increase observed in adolescents, a 3.3 fold increase over 12 months, suggests the beginning of a successful desensitization process. At this stage, the adult subgroup is inconclusive due to a small sample size and a high placebo effect.

* On July 17, 2014, DBV Technologies, creator of Viaskin®, a new paradigm for the treatment of food allergies, announced that the last patient in its phase IIb ‘VIPES’ study (VIaskin® Peanut’s Efficacy and Safety) has completed the last food challenge visit after 12 months of treatment. Additionally the VIPES study drop-out rate was only at 6.4%, far below the 15% drop-out rate initially anticipated. DBV confirms that it will report VIPES 12-month topline results in October 2014.
The first patient in VIPES was enrolled on July 31st 2012. The objectives of this 12-month dose-finding study with Viaskin® Peanut were as follows:
- In terms of efficacy, analysis of the desensitizing effect of each of the 3 active treatment doses (50 ?g, 100 ?g and 250 ?g) versus placebo. Efficacy of desensitization is defined as the difference of success rate of a treatment arm versus placebo. Success per patient is objectivized by the ability to consume symptom-free a significant higher amount of peanut after 12 months of treatment;
- In terms of safety, analysis of the frequency, duration and severity of Adverse Events triggered by Viaskin® Peanut versus placebo.
Subjects enrolled in VIPES were proposed to continue in an open-label follow-up study of VIPES (OLFUS-VIPES). Subjects who completed the VIPES study will receive an additional 24 months of Viaskin® Peanut treatment followed by a 2-month period without treatment in order to assess the level of sustained tolerance. OLFUS-VIPES study is at the same sites. From the 207 subjects who completed VIPES, 170 decided to continue into OLFUS-VIPES (82%), confirming their high interest and satisfaction with Peanut EPITTM to treat their peanut-allergy. 

* On October 15, 2013, DBV Technologies has provided a clinical update on VIPES (Viaskin Peanut’s Efficacy and Safety), a randomized, Phase IIb clinical trial of Viakin Peanut in peanut allergic patients. During the second Data and Safety Monitoring Board meeting held on September 9, 2013, the independent members reviewed the safety data of all the 221 subjects randomized and treated in the VIPES study. The safety data reviewed covered duration of treatments from 1 month up to 11 months. The DSMB concluded that the VIPES study presented no safety concerns and recommended DBV to proceed with the study as per protocol. DBV anticipates reporting VIPES 12-month topline data during the second half of 2014. Viaskin® Peanut was granted Fast Track designation by the FDA.

* On July 8, 2013, DBV Technologies has announced the completion of enrollment in its global phase IIb clinical trial, VIPES (Viaskin Peanut’s Efficacy and Safety), a 12-month treatment study with Viaskin® Peanut. DBV anticipates reporting 12-month topline data during the second half of 2014. VIPES’ results will guide the design of the subsequent Phase III clinical trial.

Viaskin® Peanut development program was granted Fast Track designation by the FDA.