DBV Technologies

Topline Results from Two-Year Follow-Up Study of Viaskin Peanut Show Long-Lasting and High Levels of Desensitization to Peanut

Press Release Montrouge, France, October 24, 2016

Topline Results from Two-Year Follow-Up Study of Viaskin Peanut Show Long-Lasting and High Levels of Desensitization to Peanut

Favorable safety and high compliance were reported in OLFUS, consistent with prior results

A vast majority of children continue to respond to treatment and tolerate larger doses of peanut, including patients treated with Viaskin Peanut 250 micrograms for up to 36 months

Peanut-specific biomarkers reflect strong immunomodulation in patients

After two months of treatment discontinuation, sustained responses were observed in all children who qualified for and completed a food challenge at month-26

DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), today 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 treatment^[i] 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 micrograms 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."