DBV Technologies announces primary endpoint met in VIPES, Viaskin Peanut's Phase 2b clinical trial in peanut allergy

DBV Technologies announces primary endpoint met in VIPES, Viaskin Peanut's Phase 2b clinical trial in peanut allergy

Largest clinical trial in peanut allergy desensitization ever completed, VIPES meets primary endpoint with Viaskin Peanut at the 250 µg dose with safety profile confirmed and excellent patient compliance demonstrated
 

By Lloyd Dunlap

BAGNEUX, France—DBV Technologies has announced topline results for its VIPES (Viaskin Peanut's Efficacy and Safety) phase 2b clinical trial of Viaskin Peanut in peanut allergic patients. The trial met its primary endpoint at the highest explored dose (Viaskin Peanut 250 µg), 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 250µg 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 percent. The trial drop-out rate was 6.4 percent, below the 15 percent rate initially anticipated. The VIPES trial is the largest clinical trial in peanut allergy desensitization ever completed, and full results of efficacy and safety will be presented at future scientific meetings.

Dr. Pierre-Henri Benhamou, chairman and CEO of DBV Technologies said in a prepared statement "We are delighted to see that VIPES provides significant support of our belief that EPIT has the potential to improve the lives of patients suffering from life-threatening peanut allergy. This is a crucial step toward finding a safe treatment for this unmet medical need and we plan to enter into a Phase 3 program informed by the results of the VIPES trial in all patient populations in approximately 12 to 18 months." Dr. Benhamou concluded: "Today is an important day for DBV. After more than 10 years of intense development, we believe that a major medical breakthrough in the field of immunotherapy is within our grasp."

Bertrand Dupont, chief technical officer and co-founder of DBV Technologies said, "Being at the origin of the Viaskin technology, I am very pleased to see that, throughout the trial, treatment compliance was so high. We believe this demonstrates that our product candidate is patient friendly and well-suited for the treatment of allergy."

In VIPES, a double-blind, placebo-controlled, multicenter Phase 2b clinical trial, 221 patients highly allergic to peanut were randomized to either a 50 µg, 100 µg or 250 µg peanut protein dose of Viaskin Peanut versus placebo. The trial was prospectively organized across the three dose levels with two patient strata composed of three different patient age groups; children (113 subjects, ages 6-11) for the first stratum and adolescents (73 subjects, ages 12-17) plus adults (35 subjects, ages 18-55) for the other strata. All patients received a daily application of the Viaskin Peanut patch over a 12-month treatment period. 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 began 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 µg 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 µg dose. In this arm, 50 percent of patients responded, compared to 25 percent in the placebo group, showing statistical significance (p=0.0108).

Specifically, 53.6 percent of children responded to treatment compared to a 19.4 percent response in placebo (p=0.008). Children treated with Viaskin showed a strong increase in peanut consumption, with an increase in Least Squares Mean. LSM is obtained from 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.

 

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 with a response rate of 38.9 percent in the active arm versus 22.2 percent in the corresponding placebo group. A statistically significant improvement in the adolescents' ability to consume peanut protein was also observed, as the LSM in change of CRD versus placebo 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 the small sample size and a high placebo effect.

 

Source: DBV Technologies