DBV Technologies (Euronext: DBV – ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, today announced that topline findings from the first 12 months of the OLFUS-VIPES study, or OLFUS, support the long-term safety and efficacy of Viaskin Peanut for the treatment of peanut allergy. The Viaskin Peanut patch is the company’s lead product candidate, which is based on epicutaneous immunotherapy (EPIT®), a proprietary technology platform that can deliver biologically active compounds to the immune system through intact skin without allowing compound passage into the blood. OLFUS is an ongoing, open-label, follow-up study to VIPES, the company’s Phase IIb clinical trial with Viaskin Peanut. DBV previously reported positive results from VIPES in September 2014, and is on track to begin a Phase III clinical trial, ‘PEPITES’, with Viaskin Peanut 250 μg in children (ages 4-11) in the fourth quarter of 2015.
Dr. Pierre-Henri Benhamou, Chairman & Chief Executive Officer of DBV Technologies, said:
We are committed to improving the life of food allergy patients without disrupting their already burdened daily lives. With these initial results from OLFUS, we believe that we have generated sufficient scientific and clinical data to evidence that, if approved, Viaskin Peanut could be an answer to patients, caretakers, and clinicians’ need for a safe, patient-friendly and potent treatment for peanut allergy.
During the first 12 months of OLFUS, no drug-related epinephrine use or serious adverse events (SAEs) due to Viaskin Peanut were reported. The study’s median compliance rate, which was maintained at 96%, was also consistent with previously reported results. A preliminary analysis of the OLFUS data showed that 12 additional months of therapy with Viaskin Peanut 250 μg increased the number of patients benefiting from treatment to 70% in OLFUS from 50% in VIPES, with 80% of children (ages 6-11 at entry in VIPES) responding to therapy after 24 months. Patients who received placebo for one year in VIPES and received Viaskin Peanut for 12 months in OLFUS showed a 50% response rate, which was consistent with findings from VIPES. DBV plans to present the full study results at upcoming scientific congresses.
Children treated for 24 months with Viaskin Peanut 250 μg
- Both treatment benefit and consumption of peanut protein significantly increased with an additional 12 months of therapy.
- Out of the 28 children treated for 12 months with Viaskin Peanut 250 µg in VIPES, 21 enrolled in OLFUS. One patient was lost to follow-up, but no other discontinuations were reported.
- In this subgroup, 80.0% of patients responded to treatment compared to 57.1% at the OLFUS baseline, consuming a 1,884 mg mean cumulative reactive dose (CRD) of peanut protein compared to a mean of 1,068 mg at the OLFUS trial initiation.
- Serological markers in OLFUS showed the strengthening of the immunological changes initially observed in VIPES. After 24 months, a median 40% decrease from the VIPES baseline value in peanut-specific immunoglobulin E (IgE) was observed, while the high median levels in immunoglobulin G4 (IgG4) were maintained at an 800% increase from the VIPES baseline.
Placebo-treated children in VIPES treated for 12 months with Viaskin Peanut
- New data from children treated for 12 months with Viaskin Peanut were consistent with the previously reported safety and efficacy results observed in this patient population.
- Out of the 31 children who received placebo for 12 months in VIPES, 29 enrolled in OLFUS. One patient was unwilling to continue with treatment, but no other discontinuations were reported.
- A 53.6% response rate after 12 months of treatment with Viaskin Peanut was observed compared to 17.2% at the OLFUS baseline. Patients consumed a mean CRD of 722 mg of peanut protein compared to 190 mg at the OLFUS baseline.
- The evolution of serological markers for patients treated with Viaskin Peanut for 12 months was also consistent with data previously reported from VIPES.
Adolescents and adults treated for 12 and 24 months with Viaskin Peanut 250 μg
- For adolescent and adult patients treated for 24 months, no additional significant clinical response was observed relative to the OLFUS baseline. A response rate consistent with results observed in VIPES was shown in treatment-naïve adolescents and adults who received 12 months of therapy during OLFUS. These results confirm the company’s intention to explore a higher Viaskin Peanut dosing regimen in this patient population.
James R. Baker, Chief Executive Officer and Chief Medical Officer of the Food Allergy Research & Education patient organization (FARE), commented:
These important results extend prior studies showing the ability of DBV's Viaskin Peanut patch to enhance protection of peanut allergic children. The results also show additional benefit from longer term use of the patch. The safety profile is also impressive as no significant side-effects were noted. If this is confirmed in DBV's Phase III trial, Viaskin could be a breakthrough therapy for young children with peanut allergy.