DBV Technologies (DBVT) Announces Topline data from Two-Year OLFUS-VIPES Study; No SAEs Reported

October 24, 2016 4:33 PM EDT

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DBV Technologies (Nasdaq: DBVT) announced topline results from the two-year OLFUS-VIPES study supporting the durable effect and favorable safety profile of Viaskin Peanut for the treatment of peanut-allergic children. OLFUS-VIPES, or OLFUS, is an open-label, follow-up study to VIPES, the Company’s Phase IIb clinical trial of Viaskin Peanut. Previously, the Company reported positive results from VIPES in September 2014 and provided an interim analysis from the first 12 months of OLFUS in October 2015.

Investigators in OLFUS followed patients who completed the VIPES study for an additional 24 months in order to assess the long-term safety and efficacy of Viaskin Peanut beyond the VIPES primary endpoint at 12 months. As in VIPES, participants’ response to treatment1 was evaluated by a double-blind, placebo-controlled food challenge (DBPCFC), which was administered at month-12 and month-24 during the OLFUS study.

Consistent with prior observations in OLFUS, the favorable safety, tolerability and compliance profile of Viaskin Peanut was maintained from year-1 to year-2, with no treatment-related epinephrine use or serious adverse events (SAEs) reported in any of the subgroups. Patient compliance, which measures adherence to treatment dosing, was maintained at a median rate of 95.5%.

Highlights from the two-year follow-up results in children:

Children treated with Viaskin Peanut 250 μg throughout the duration of VIPES and OLFUS were observed to maintain long-lasting desensitization to peanut for a total of 36 months. Observations in these patients include the following:

  • Treatment benefit was observed to be long-lasting, with 83% (15/18) of children continuing to respond to treatment during the second year of OLFUS.
  • By month-24, a significant proportion of children were tolerating larger doses of peanut compared to the OLFUS baseline.
  • Mean and median cumulative reactive dose (CRD) of peanut protein, which measures threshold reactivity during the DBPCFC, progressed to 2,454 mg and 1,440 mg, respectively, at the completion of OLFUS; from 1,884 mg and 1,440 mg, respectively, during the month-12 interim assessment; and from 1,068 mg and 444 mg, respectively, at the OLFUS baseline.
  • Several children reached a CRD of at least 5,040 mg of peanut protein at the completion of the study (7/18 patients).
  • Peanut-specific immunoglobulin E (IgE) levels were maintained below baseline from year-1 to year-2, and immunoglobulin G4 (IgG4) levels remained high.
  • After two years, 14% (3/21) of patients in this cohort discontinued treatment, none reportedly related to Viaskin Peanut.

“Peanut allergy is a debilitating disease affecting millions of patients worldwide, but despite its rapidly increasing prevalence there are still no FDA approved treatments. These results help validate the potential of Viaskin Peanut to generate meaningful and long-lasting desensitization to peanuts in children ages four to 11. If the product is approved after the ongoing Phase III trial, we will be one step closer to providing peanut allergic children with protection against the life-threatening risks associated with accidental allergen exposure,” said Dr. Stephen A. Tilles, Executive Director, ASTHMA Inc. Clinical Research Center, Physician Partner at Northwest Allergy & Asthma Center (NAAC), and Site Principal Investigator for the OLFUS study in Seattle. “One of Viaskin Peanut’s most important attributes has been its safety and tolerability profile. This is likely the reason for the high degree of treatment adherence during this several year study, and may be an important determinant of its success in clinical practice.”

Despite treatment with suboptimal dose regimens, children treated with Viaskin Peanut 50 μg or 100 μg in VIPES, who later received the 250 μg dose during OLFUS, showed increased levels of desensitization at month-24. Additional exploratory observations include the following:

  • A majority of children receiving suboptimal dose regimens responded to treatment by the completion of OLFUS.
  • Patients generally increased oral peanut intake over time in a dose-dependent manner.
  • Patients initially treated with the lowest dose were more likely to discontinue therapy and were also less likely to achieve the highest CRD levels at month-24.

Preliminary analysis on sustained benefit following treatment discontinuation:

All subjects who were unresponsive to a cumulative reactive dose of above 1,440 mg of peanut protein at the month-24 DBPCFC in OLFUS were eligible to continue the study for two additional months. During this period, patients did not receive treatment and were required to maintain a peanut-free diet. In an exploratory analysis, all of the 19 children who completed the DBPCFC at month-26 reached a CRD of at least 1,440 mg, showing a meaningful durability of response in the absence of treatment.

Complete results from the OLFUS study will be submitted for presentation at a future medical meeting.

“We would like to thank the patients, caregivers, and clinicians who devoted their time to complete this long trial,” said Dr. Hugh Sampson, Chief Scientific Officer of DBV Technologies, Director of the Jaffe Food Allergy Institute at Mount Sinai, and Co-Principal Investigator of the OLFUS-VIPES study. “These three years of epicutaneous immunotherapy data seem to support DBV’s innovative and proprietary approach of desensitizing food allergic-patients through the skin in order to minimize safety concerns associated with allergen exposure. We are also excited to see durable responses in the absence of treatment and no peanut consumption, although additional analyses will need to be performed to better understand these findings. These results suggest that the immunomodulatory changes observed in patients treated with Viaskin may be more sustained.”

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