DBV Technologies S.A 6-K, filed Jan 9, 2020
DBV Technologies S.A. (DBVT)
About this 6-K
DBV Technologies S.A filed this 6-K on January 9, 2020.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2020
Commission File Number: 001-36697
DBV TECHNOLOGIES S.A.
(Translation of registrant’s name into English)
177-181 avenue Pierre Brossolette
92120 Montrouge France
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
EXPLANATORY NOTE
On January 8, 2020, DBV Technologies S.A. announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial, or PEOPLE trial, evaluating the long-term efficacy and safety of investigational Viaskin Peanut in peanut-allergic children ages 4 to 11 years. DBV Technologies S.A. prepared a presentation in connection with the topline results of the PEOPLE trial, which it intends to use in conferences and meetings with investors. Copies of the press release and the presentation are filed with this Report of Foreign Private Issuer on Form 6-K as Exhibits 99.1 and 99.2, respectively, and are incorporated herein by reference.
EXHIBIT LIST
| Exhibit |
Description | |
| 99.1 | Press Release dated January 8, 2020. | |
| 99.2 | Presentation of DBV Technologies S.A. dated January 8, 2020. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| DBV TECHNOLOGIES S.A. | ||||||
| Date: January 8, 2020 | By: | /s/ Daniel Tassé | ||||
| Name: | Daniel Tassé | |||||
| Title: | Chief Executive Officer | |||||
Exhibit 99.1
DBV Technologies Reports Positive Three-Year, Long-Term Data from the PEOPLE Phase III Open-Label Extension Study of Viaskin Peanut in Children with Peanut Allergy
Patients demonstrated durable, long-term clinical benefit with an additional two years of treatment
Low discontinuations due to adverse events observed
Study represents the largest long-term peanut allergy immunotherapy trial to date, with high compliance enabling extended study participation
DBV Technologies (the “Company”) (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. After three years, 75.9% (107/141) of patients had increased their ED from baseline, and 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein by year three.
“These new long-term data support the overall clinical benefit of Viaskin Peanut that we’ve observed to date in Phase II and III clinical trials. We are particularly pleased to see that approximately three out of four patients showed an increase in their eliciting dose over three years, regardless of their individual baseline, with roughly 1 in 7 patients able to consume 5,444 mg peanut protein without reacting during the Month 36 oral food challenge,” said Dr. David Fleischer, Principal Investigator of PEPITES and PEOPLE, Director, Allergy and Immunology Center and Section Head, Children’s Hospital Colorado. “Most peanut-allergic children react to a single peanut (300 mg of peanut protein) or less, with some reacting to as little as 1 mg, leading many children and families to experience constant fear of accidental exposure, loss of normalcy and decreased quality of life.
These new data provide further evidence that Viaskin Peanut may reduce the risk of reaction from accidental exposure by increasing threshold reactivity through a treatment option that could be safe and convenient.”
The PEOPLE study is an ongoing open-label extension study evaluating the long-term safety, tolerability and efficacy of Viaskin Peanut 250 µg in patients who have completed the Phase III PEPITES trial. Of the 213 patients who were randomized in the active treatment arm of PEPITES and completed the 12-month trial, 198 patients opted to enter the PEOPLE study (safety population). Of these patients, 148 were considered completers after 36 months and 141 patients completed all treatment according to the study protocol without major deviations. Efficacy data were analyzed from these 141 patients (per-protocol).
Topline results from PEOPLE support the long-term tolerability and clinical benefit of Viaskin Peanut, demonstrating desensitization over 36 months of treatment. After 36 months, 51.8% (73/141) of patients reached an ED of at least 1,000 mg peanut protein, an increase relative to Month 12, 40.4% (57/141). In addition, 13.5% (19/141) of patients completed the food challenge without meeting stopping criteria at 36 months (cumulative dose of 5,444 mg). At Month 36, the mean cumulative reactive dose (CRD) was 1,768.8 mg (median 944 mg) compared to 223.8 mg (median 144 mg) at baseline.
The safety profile of Viaskin Peanut was consistent with that observed in the clinical program to date in over 1,000 patients. During PEOPLE, the most common adverse events were mild to moderate skin reactions localized to the administration site and there was no epinephrine use deemed related to treatment. No treatment related serious adverse events (SAEs) were reported. One patient experienced one case of mild anaphylaxis that was determined by the investigator to be possibly related to treatment and resolved without treatment. Treatment compliance remained high throughout the study at a mean of 98% over three years of treatment.
Exploratory analyses suggest Viaskin Peanut may offer sustained effect even after a period without treatment. All participants who reached an ED ³ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge
to determine ED was administered at the end of this period (Month 38). The analysis showed that 77.8% (14/18) of the children who completed the oral food challenge at Month 38 maintained desensitization with an ED ³ 1,000 mg.
“Harnessing the important immune properties of the skin, epicutaneous immunotherapy represents a potentially unique mechanism of action that may support the sustained desensitization observed in this study even after a period without treatment. These data further advance our understanding of the profile of Viaskin Peanut, which is currently under review by the U.S. Food and Drug Administration and may offer a simple, once daily, non-invasive treatment option for children living with peanut allergy in the second half of 2020, if approved,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “Importantly, we would like to thank the children, families and investigators for participating in this study, the largest long-term trial in this underserved disease.”
The Company plans to present full study results at future medical congresses as well as submit for publication in a peer-reviewed journal.
About PEOPLE
The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 µg (NCT03013517). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment.
The study evaluates the eliciting dose after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge is 1 mg of peanut protein and escalates to the highest dose of 2,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein. For the next DBPCFCs after four and five years, the starting dose of each challenge is 10 mg of peanut protein and escalates to the highest dose of 3,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 6,440 mg peanut protein.
The analysis also includes exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin E (IgE) and immunoglobulin G4 (IgG4), and sustained desensitization following a two-month period without treatment.
About PEPITES
The Peanut EPIT Efficacy and Safety Study (PEPITES) was a global, double-blind, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of Viaskin Peanut 250 µg in children ages 4 to 11 years (NCT02636699). PEPITES was conducted in 31 centers across North America (Canada and the United States), Germany, Ireland and Australia.
Eligible patients were aged 4-11 years at screening with physician-diagnosed peanut allergy, currently following a strict peanut-free diet. Other key inclusion criteria were peanut-specific IgE >0.7 kUA/L, a peanut skin prick test with a largest wheal diameter ³6 mm (children 4-5 years) or ³8 mm (children ³6 years) at screening, and an ED (the single highest dose at which a patient exhibited objective signs/symptoms of an immediate hypersensitivity reaction) of £300 mg peanut protein based on a DBPCFC.
PRACTALL, the joint American Academy of Allergy, Asthma & Immunology (AAAAI) and European Academy of Allergy and Clinical Immunology (EAACI) published food challenge methodology that defines strict, 30-minute intervals for peanut protein dosing, was used to evaluate sensitivity to peanut at baseline and exit. Challenges were stopped when patients exhibited clear, objective symptoms based on a pre-specified symptom scoring scale. A Good Manufacturing Practice food challenge matrix was used for all peanut protein and placebo food challenges.
During PEPITES, patients’ responses were assessed using DBPCFCs. Patients were randomized 2:1 to receive either Viaskin Peanut 250 µg or placebo for 12 months. The primary endpoint was based on a responder analysis after 12 months of treatment with Viaskin Peanut 250 µg. For patients with a baseline peanut protein ED equal to or less than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment.
As a secondary efficacy endpoint, CRD was also evaluated in PEPITES to establish the total quantity of peanut protein that triggers patient reactions at Month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
During the study, investigators relied on the commonly used National Institute of Allergy and Infectious Diseases (NIAID) definition of anaphylaxis, which has been shown to be highly sensitive but only moderately specific in diagnosing anaphylaxis, in an attempt to capture as many potential reactions as possible.
Two hundred thirteen of the 238 patients randomized to the peanut-patch and 107 of the 118 patients randomized to the placebo-patch completed the study. After 12 months of therapy, patients treated with Viaskin Peanut
showed a statistically significant improvement in the ED of peanut required to provoke an allergic reaction at food challenge compared with placebo. After 12 months of treatment, we observed that 35.3% of patients on Viaskin Peanut 250 µg were responders, compared to 13.6% of patients in the placebo group (treatment difference = 21.7%; 95% CI = 12.4% - 29.8%; p<0.001). An increase in the CRD was also observed between the treatment and placebo groups (nominal p-value<0.001) after 12 months. The median CRD of patients in the treatment group increased from 144 mg at baseline to 444 mg at Month 12, compared with no improvement in the placebo group.
There were no cases of severe anaphylaxis, and only four of 238 patients (1.7%) dropped out due to treatment-emergent adverse events. A low rate of treatment-related epinephrine use was reported (2.9% treatment group vs. 0.8% placebo group). Ten cases in eight Viaskin Peanut patients (3.4%) of possibly or probably treatment-related anaphylaxis occurred; all were classified as mild or moderate without evidence of cardiovascular, neurologic, or respiratory compromise. Six of these ten cases were treated with epinephrine, and five of the eight patients continued on Viaskin Peanut in the study.
About DBV Technologies
DBV Technologies is developing Viaskin®, an investigational proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT™, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments. DBV’s food allergies programs include ongoing clinical trials of Viaskin Peanut and Viaskin Milk, and preclinical development of Viaskin Egg. DBV is also pursuing a human proof-of-concept clinical trial of Viaskin Milk for the treatment of Eosinophilic Esophagitis, and exploring potential applications of its platform in vaccines and other immune diseases. DBV Technologies has global headquarters in Montrouge, France and offices in Bagneux, France, and North American operations in Summit, NJ and New York, NY. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345), part of the SBF120 index, and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT).
Forward Looking Statements
This press release contains forward-looking statements, including statements about the potential of the EPIT platform and Viaskin® Peanut as a treatment for peanut-allergic children. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Factors that could cause actual results to differ materially from those described or projected herein include risk associated with uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals. A further list and description of these risks, uncertainties and other risks can be found in the Company’s regulatory filings with the French Autorité des Marchés
Financiers and U.S. Securities and Exchange Commission, including in the Company’s Annual Report on Form 20-F for the year ended December 31, 2018. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise forward-looking statements as a result of new information, future events or circumstances, or otherwise, except as required by law.
DBV Investor Relations Contact
Sara Blum Sherman
Senior Director, Investor Relations & Strategy
+1 212-271-0740
sara.sherman@dbv-technologies.com
DBV Media Contact
Joe Becker
VP, Global Corporate Communications
+1 646-650-3912
joseph.becker@dbv-technologies.com
Investigational Viaskin peanut in children with peanut allergy the Pepites open label extension (PEOPLE) trial: TOPLINE RESULTS Epicutaneous immunotherapy and Viaskin® Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. Exhibit 99.2
Safe harbor This presentation contains forward looking statements including, but not limited to, statements concerning the outcome or success of DBV’s clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its ability to successfully advance its pipeline of product candidates; the rate and degree of market acceptance of its products; and its ability to develop sales and marketing capabilities. Forward looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, DBV operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for DBV’s management to predict all risks, nor can DBV assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward looking statements it may make. In light of these risks, uncertainties and assumptions, the forward looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. You should not rely upon forward looking statements as predictions of future events. Although DBV believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward looking statements will be achieved or occur. Moreover, except as required by law, neither DBV nor any other person assumes responsibility for the accuracy and completeness of the forward looking statements. Forward looking statements in this presentation represent DBV’s views only as of the date of this presentation. DBV undertakes no obligation to update or review any forward looking statement, whether as a result of new information, future developments or otherwise, except as required by law. Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
Peanut allergy REPRESENTS a serious BURDEN AMID CONSTANT FEAR OF ACCIDENTAL EXPOSURE Peanut allergy is one of the most common, persistent and potentially life-threatening food allergies, affecting nearly one million children in the U.S.1 The majority of peanut-allergic children will react to 300 mg of peanut protein (approximately 1 peanut) or less, with some individuals reacting to as little as 1 mg2 A constant fear of accidental peanut exposure leads to reduced quality of life for patients and their families In clinical trials, the degree of desensitization is evaluated by the change in a patient's eliciting dose (ED)3 Based on risk modeling, immunotherapy could offer meaningful reduction of the risks associated with accidental exposures by increasing a patient’s eliciting dose4 1. Gupta R, et al. Pediatrics. 2011;128:e9-17. 2. Deschildre A, et al. Clin Exp Allergy. 2016;46(4):610-620. 3. Food and Drug Administration. Meeting of the Allergenic Products Advisory Committee. https://www.fda.gov/media/95543/download. Accessed January 7, 2020. 4. Remington BC, et al. Annals Allergy Asthma Immunol. 2019;123:488-493.e2. . Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
PEOPLE: an open-label extension of PEPItes assessing long-term effects of viaskin peanut Patients who completed the Phase III PEPITES trial were eligible to enroll in PEOPLE Safety and efficacy of long-term treatment with VP 250 μg, up to 5 years of treatment Assessment of clinical benefit after 36 months of treatment with VP 250 μg Double-blind, placebo-controlled food challenge (DBPCFC) assessing ED Sustained unresponsiveness following 2 months of treatment discontinuation (M37 & M38) Unique opportunity to assess long-term effects of epicutaneous immunotherapy (EPITTM) Maintenance and/or improvement of treatment effect Further confirmation of tolerability and safety profile observed in the clinical program to date Further explore the mechanism of action associated with EPIT, potential for differentiation relative to OIT or SLIT Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
M12 Placebo (n=118) 250 µg (n=238) N=356 4-11 years 213 107 M0 largest long-term peanut allergy immunotherapy trial to date Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. ED=eliciting dose; SU=sustained unresponsiveness. *A threshold of 15% or more on the lower bound of a 95% CI around responder rate difference was prespecified to determine a positive trial result. The prespecified 15% lower bound of the 95% CI of the difference between treatment groups was not met (95% CI:12.4, 29.8) in the PEPITES trial. The authors of the JAMA publication concluded that the clinical relevance of this is not known.1 †The population for the key efficacy measurement per the Statistical Analysis Plan submitted to FDA. 1. Fleischer DM, et al. JAMA. 2019;321:946-955. Primary endpoint* responder definition: Patients with a M0 ED ≤10 mg: responder if ED ≥300 mg at M12 Patients with a M0 ED >10 mg and ≤300 mg: responder if ED ≥1000 mg at M12 PEPITES PEOPLE 198 100 M12 M24 184 148 91 83 M24 M36 Roll-over to 250 mg M36 M48 M48 M60 M38 Populations Completers†=148 Per Protocol=141 Full Analysis Set for Safety=198 93% of patients that completed PEPITES enrolled in PEOPLE SU Double-blind, placebo-controlled food challenge. M38 Key efficacy measurement Percentage of patients reaching an ED ≥1000 mg after 24 months of additional treatment with 250 mg M60 SU
Clinically meaningful changes in Eliciting Dose maintained or improved over 3 years 75.9% (107/141) demonstrated an increase in ED from baseline (M0) to Month 36 51.8% (73/141) reached an ED of ≥1,000 mg at Month 36 40.4% (57/141) reached an ED of ≥1,000 mg at Month 12† 67.4% (62/92) of patients who had a Month 0 ED of ≤100 mg reached an ED of at least 300 mg Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. PEOPLE PP (N=141) % of Patients M0 M12 M36 >2000* 2000 1000 300 100 30 10 3 1 *ED >2000 mg included subjects: passing the 2000 mg dose at M12 without stopping criteria, passing the 2000 mg dose at M36 without stopping criteria, OR starting the second dose of 2000 mg at M36. †PEOPLE criterion: ∆ (M36-M12)=11.3% [2.8%; 19.6%].
Marked improvements in cumulative reactive dose (CRD) with long-term EPIT treatment - median value In PEOPLE, 13.5% (19/141) of patients tolerated* the full DBPCFC at 36 months (cumulative dose of 5,444 mg) Mean CRD of 1,768.8 mg, equivalent to roughly 6 peanuts, at Month 36 24.1% (34/141) reached a CRD of 3,444 mg at month 36 compared to 15.6% (22/141) at month 12† 17.7% (25/141) reached a CRD of 5,444 mg at month 36† DBPCFC=double-blind, placebo-controlled food challenge. *Tolerated=passed the DBPCFC without meeting PRACTALL stopping criteria. †At month 12, the starting dose of the DBPCFC is 1 mg of peanut protein and escalates up to the highest dose of 2,000 mg to reach a maximum total cumulative dose of 3,444 mg of peanut protein. At month 36, the starting dose of the DBPCFC is 1 mg of peanut protein and escalates up to the highest dose of 2,000 mg peanut protein, possibly repeated once to reach a maximum total cumulative dose of 5,444 mg of peanut protein. For month 48 and 60, the starting dose will be 10 mg of peanut protein and the maximum dose will be 3,000 mg of peanut protein, giving a maximum cumulative dose of 6,440 mg. Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. Month 12 Baseline 1 mg 3 mg 10 mg 30 mg 100 mg 300 mg 1,000 mg 2,000 mg 2,000 mg DBPCFC† Month 36 PEOPLE Per Protocol (PP) 144 444 944
Consistent treatment effect across studies USING DIFFERENT endpoint criteria *Results for 250 µg cohort, ages 6-11; †SU defined in PEOPLE as maintaining ED ≥1,000 mg; all participants who reached an ED ≥1,000 mg at Month 36 were eligible to continue the study for 2 additional months without treatment and required to maintain a peanut-free diet. A DBPCFC was administered at Month 38. SU defined in OLFUS as patients who did not react to a CRD >1,440 mg; patients needed to be unresponsive to a CRD of ≥1,440 mg peanut protein at the Month 24 DBPCFC to continue the study for two additional months without treatment and required to maintain a peanut-free diet. ‡Results for 250 µg cohort during OLFUS, ages 6-11 1. Sampson HA, et al. JAMA. 2017;318:1798-1809. 2. Brown-Whitehorn T, et al. Presented at: Annual Meeting of the European Academy of Allergy and Clinical Immunology; May 26-30, 2018; Munich, Germany. PEOPLE results when analyzed per: Phase III PEOPLE key efficacy measurement: 51.8% reached an ED of ≥1000 mg at Month 36 Phase III PEPITES response criteria: 55.3% (78/141) reached an ED of ≥300 mg (for patients with a baseline ED ≤10 mg) or ≥1000 mg (for patients with a baseline ED >10 mg and ≤300 mg) at Month 36 Phase II OLFUS response criteria: 66.0% (93/141) reached an ED of ≥1,000 mg or ≥10-fold the baseline ED at Month 36 As a reminder, in the OLFUS study, 83% (15/18) of patients responded at Month 361,* Sustained unresponsiveness (SU)†: Results suggest that desensitization is maintained after discontinuing treatment for 2 months (Month 37 & 38) 77.8% (14/18) met the SU criteria in PEOPLE 73.7% (14/19) met the SU criteria in OLFUS2,‡ Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. PEOPLE Criterion PEPITES Criterion OLFUS Criterion PEOPLE Per Protocol (PP) Percentage of Subjects (%)
Continued Immune modulation beyond 12 months Exploratory analyses across both PEPITES and PEOPLE showed that changes in peanut-specific biomarkers, including immunoglobulin G4 (IgG4) and immunoglobulin E (IgE), support the immunomodulatory effect with Viaskin Peanut Peanut IgG4 levels progressively increased throughout the first 18 months of treatment and remained at peak levels for the remainder of the treatment to 36 months IgE levels increased initially at the start of the study and then returned to baseline, remaining around baseline through 36 months Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
safety profile consistent with that observed in the clinical program to date No treatment-related serious adverse events (SAEs) were reported Most commonly reported treatment-related AEs were mild to moderate skin reactions Local administration site reactions observed in 92.9% (184/198) of patients over 36 months In year 3 of treatment, local skin reactions observed in 29.9% (55/198) of patients 4 children discontinued due to treatment-emergent adverse events between the start of PEOPLE and Month 36 No epinephrine intake related to treatment observed in the PEOPLE study 1 patient experienced 1 possibly-related mild anaphylaxis* that resolved without treatment Treatment compliance remained high throughout the study Mean compliance of 98% observed over 3 years of treatment High adherence and low dropout rate 50 patients discontinued† between the start of PEOPLE and Month 36 27 patients discontinued between Month 30-36, with 21 of the 27 identifying food challenge fright/distaste as the reason for consent withdrawal *Anaphylaxis was defined according to NIAID, which has been shown to be highly sensitive but moderately specific, in an attempt to capture as many reactions as possible. Severe anaphylaxis was defined by presence of cyanosis, hypoxia, hypotension, confusion, loss of consciousness, or incontinence. †Includes those who discontinued prior to or during the Month 36 DBPCFC. Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority.
Summary Approximately 3 out of 4 patients experienced an increase in their ED from baseline, showing a majority of patients benefited from the investigational therapy 51.8% reached an eliciting dose (ED) of at least 1,000 mg peanut protein (about three peanuts) Robust treatment response with 13.5% of patients tolerating* a cumulative dose of 5,444 mg at Month 36 Median CRD increased approximately 7x from baseline (144 mg) to Month 36 (944 mg) 77.8% (14/18) demonstrated sustained unresponsiveness, defined by maintaining an ED ≥ 1,000 mg following a 2-month period without Viaskin Peanut treatment, suggesting that desensitization may be maintained after discontinuing treatment Safety profile was consistent with previously published controlled Phase 3 studies Viaskin Peanut was observed to be well tolerated over the three-year treatment period No treatment-related epinephrine use reported in PEOPLE Consistent results observed throughout Phase II and Phase III clinical studies EPIT has the potential to modify the immune response in a durable way, offering potential long-term protection against the risk of reaction from accidental exposure Epicutaneous immunotherapy and Viaskin Peanut are under clinical investigation and have not been approved for marketing by any health or regulatory authority. *Tolerated=passed the DBPCFC without meeting PRACTALL stopping criteria.