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DBV Technologies: takes stock of its operations and its activity

Montrouge, France, June 26 (8:30 a.m.CEST) 2020

DBV Technologies takes stock of its operations and activity

Further review of the Viaskin Peanut Biologics License Application (or “BLA”) application for the treatment of peanut allergy in children 4 to 11 years of age

The Company immediately initiates a plan for a restructuring plan to extend its cash flow horizon pending clarification from the FDA

EPITOPE Phase III clinical trial continues in children 1 to 3 years old – benefits of treatment are seen in Part A analysis

DBV Technologies (the “Company”) (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical biopharmaceutical company, announced today that the Company has not yet received new information from the On the part of the FDA concerning its BLA request for Viaskin ™ Peanut, it had undertaken a complete review of its activities in order to better position DBV in the event of a delay in the examination schedule for Viaskin Peanut BLA. Following this review, the Board of Directors approved the immediate initiation of a plan for a comprehensive restructuring plan, which should include a significant reduction in staff. The Company has launched, in accordance with French law, the compulsory consultation process with representatives of the Social and Economic Committee of the Company.

We have carefully examined the situation and, taking into account the prevailing uncertainties, the objective of the draft plan which we are launching is to safeguard our essential functions, to extend the cash horizon and to maintain all operational latitude with a view to be able to offer peanut allergy patients the first and only epicutaneous immunotherapy treatment, subject to its approval.”Said Daniel Tassé, CEO of DBV Technologies,“We remain convinced that Viaskin Peanut, based on the clinical data observed to date, could change the paradigm of long-term treatment of peanut allergies and is well suited to the current health environment. ”

Update on the finances and activity of the Company:

As reported on March 16, 2020, the FDA has notified DBV that it is concerned about the impact of patch adhesion on the drug’s effectiveness. The Company promptly submitted additional test results which it believes respond to questions posed by the FDA and have asked the FDA for feedback on the remainder of the process. These analysis results, which show that the majority of patients treated with Viaskin Peanut have had enough daily application time to experience clinical benefit, have also been published in two peer-reviewed publications1.2. Since the submission of these test results last April and the requests made by the Company, the FDA has not provided any other information beyond the fact that the data transmitted were being examined and that the date the target of August 5, 2020 remained unchanged. Given the lack of clarity on the part of the FDA, DBV initiates a plan for a restructuring plan to allow the Company to continue the BLA review process and if approved, prepare to put Viaskin Peanut on the market, preserving its cash horizon.

DBV plans to focus on Viaskin Peanut and cut all of its other clinical programs and pre-clinical expenses. The Company plans to implement significant cost reduction measures throughout the organization, while preserving key activities and skills. On the basis of the draft updated plan and the proposed cost structure, DBV now estimates that its current balance of cash and cash equivalents of € 262.4 million at the end of the first quarter of 2020 is sufficient to finance its operations well beyond previous forecasts for the first quarter of 2021. In addition, the Company will release its updated cash flow horizon once the FDA’s feedback on Viaskin Peanut’s BLA application review process has been received.

Update on clinical trials:

All ongoing clinical trials will continue as planned, with recruitment schedules affected by COVID-19. Global collaboration with Nestlé Health Science in the development of candidate diagnostic products will also continue as planned, subject to the impact of COVID-19. In this unprecedented period, DBV will continue to take the additional measures necessary to maintain the safety of its employees and to mitigate the potential impact of COVID-19 on the business of the Company.

The Company is also providing an update on the ongoing EPITOPE clinical trial, a two-part Phase III pivotal trial evaluating the safety and efficacy of Viaskin Peanut in the treatment of young children aged 1 to 3 with peanut allergy, in supplement to the proposed indication for children aged 4 to 11 currently being reviewed by the FDA. As previously communicated, Part A showed that the two doses studied (100 µg (n = 20) and 250 µg (n = 21)) were described as well tolerated, without serious treatment-related adverse effects (SAEs). Patients in both treatment groups showed consistent treatment effect after 12 months of therapy, as shown by the results of a double-blind placebo-controlled food challenge test and the results of biomarker analyzes. Part A patients were not included in Part B and the study was not statistically designed to demonstrate the superiority of one dose or the other over placebo. These results validate the current study on the 250 µg dose in this age group, which is the dose also studied in Part B of the study.

Due to the current COVID-19 pandemic and the uncertainty surrounding the recruitment of the study, the Company plans to take stock in the second half of 2020 of the sample size and the recruitment expectations of the Part B. The Company will then assess potential options, including adjusting target recruitments for Part B.

“These first data from EPITOPE, our second Phase III program from Viaskin Peanut, support an epicutaneous immunotherapy approach to treat food allergy in this age group,” says Dr. Pharis Mohideen, Medical Director of DBV Technologies. “There is a growing body of scientific evidence supporting the importance of treating peanut allergy patients from an early age, when they are most likely to be diagnosed. These results are important not only for understanding the science of patch immunotherapy in different age groups, but also for advancing a potential treatment solution for very young patients. “

About the EPITOPE study
EPITOPE should allow the recruitment of approximately 400 patients (51 in part A and 350 in part B) in around fifty centers in North America (Canada and the United States), Europe and Australia. EPITOPE is a two-part clinical trial: Part A was designed to assess the safety of Viaskin Peanut 100 µg and 250 µg and to determine the maximum dose that can be tolerated, and Part B was designed to assess the efficacy and safety of the chosen dose. In part A, 51 patients were divided into a ratio of 1: 2: 2 and received either placebo or Viaskin Peanut 100 μg or 250 μg. A safety analysis was carried out by the independent monitoring and follow-up committee (DSMB) after three months of treatment in order to determine the maximum tolerated dose to be studied in part B. No safety concerns were observed with the either of the two doses, and the patients will continue their respective treatment and will keep the same dose of active treatment or placebo as in Part A for 12 months. In Part B, patients will be divided into a 2: 1 ratio and will receive Viaskin Peanut 250 µg or placebo.

The primary endpoint is based on an analysis of the response after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo-controlled food challenge test. For patients with a reactive dose (DR) of 10 mg or less, a patient will be considered a responder if they reach a reactive dose of 300 mg or more of peanut protein after 12 months of treatment. For patients with a DR greater than 10 mg, a patient is considered to be a responder if he achieves a DR equal to or greater than 1000 mg of peanut protein after 12 months of treatment. The cumulative reactive dose (DCR) will also be evaluated as a secondary efficacy criterion in the EPITOPE study to establish the total quantity of peanut proteins triggering reactions in patients at the 12th month of active treatment compared to placebo. Serological markers will also be measured at baseline, at the 3rd, 6th and 12th months, to characterize the immunological changes in patients.

At the end of EPITOPE, all eligible patients will be offered to participate in the long-term open-label follow-up study, EPOPEX on Viaskin Peanut 250μg. Patients participating in the EPOPEX study will be kept blind to their respective treatments in EPITOPE until the end of the study and public communication of the results.

About DBV Technologies
DBV Technologies develops Viaskin®, an exclusive technological platform with vast fields of potential applications in immunotherapy. Viaskin uses epicutaneous immunotherapy, or EPIT, which is the method developed by DBV Technologies to deliver biologically active compounds to the immune system through intact skin. With this new category of non-invasive product candidates, the company is working to transform the management of patients with a food allergy, for whom there is no approved treatment. DBV Technologies’ food allergy programs include clinical trials on Viaskin Peanut and Viaskin Milk, as well as preclinical development of Viaskin Egg. DBV Technologies is also conducting a clinical proof of concept study in humans for the treatment of eosinophilic esophagitis and continues to explore the potential applications of its platform in the area of ​​immunization and other immune diseases. DBV Technologies has a global headquarters in Montrouge (France), offices in Bagneux (France) and operational structures in North America in Summit, NJ and New York, NY. The company’s shares are traded on segment B of Euronext Paris (mnemonic: DBV – ISIN: FR0010417345), are part of the SBF120 index and are also traded on the Nasdaq Global Select Market in the form of American Depositary Shares (each representing half of an ordinary share) (mnemonic: DBVT).

Forward-looking statements
This press release may contain forward-looking statements and estimates, including statements regarding the potential benefits of the proposed restructuring of the company’s operations and the potential cost savings, the schedule of the company’s ongoing clinical trials, including, to in light of the continuing impact of the COVID-19 pandemic, the potential of ViaskinTM Peanut as a treatment for children with peanut allergies, the conduct and schedule of clinical trials of Viaskin Peanut and the Company’s research, development and regulatory plans for its product candidates and its preclinical pipeline, including interactions of the Company planned with the FDA and the target date for obtaining the BLA. These forward-looking statements and estimates do not constitute promises or guarantees, and involve substantial risks and uncertainties. At this stage, the marketing of the company’s products is not allowed in any country. Among the factors likely to cause the actual results to differ significantly from those described or projected in this document, the uncertainties generally linked to research and development activities, clinical trials, examinations and approvals may be cited corresponding regulations, in particular the impact of the COVID-19 pandemic, and the company’s ability to carry out its plans for restructuring plans. In addition, the timing of any FDA action and any regulatory pathways to follow cannot be guaranteed. A detailed list and description of these risks, contingencies and other risks appear in the documents filed by the company with the Autorité des Marchés Financiers as part of its regulatory obligations, in the documents and reports of the company filed with the Securities and Exchange Commission in the United States, and in the company’s annual report on Form 20-F relating to the fiscal year ended December 31, 2019, and in the documents and future reports to be made by the company. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Except when required by applicable regulations, DBV Technologies makes no commitment to update or revise the information contained in this press release.

DBV Investor Relations Contact
Sara Blum Sherman
Director, Investor Relations and Strategy
+1 212 271-0740
sara.sherman@dbv-technologies.com

DBV Media Contact
Joe Becker
Vice President, International Corporate Communications
+ 1-646-650-3912
joseph.becker@dbv-technologies.com

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[1] Fleischer DM, Chinthrajah S, et al. An Evaluation of Factors Influencing Response to Epicutaneous Immunotherapy For Peanut Allergy in the PEPITES Trial. Allergy & Asthma Proceedings. 2020; 41: 1-10. doi: 10.2500 / aap.2020.41.200047.
[2] Fleischer DM, Spergel JM, et al. Evaluation of Daily Patch Application Duration For Epicutaneous Immunotherapy For Peanut Allergy. Allergy & Asthma Proceedings. 2020; 41: 278-284. doi: 10.2500 / aap.2020.41.200045.