As a result, the Board of Directors has approved the immediate initiation of a global and comprehensive restructuring plan, which is expected to include a significant reduction in workforce. The Company has initiated, in compliance with French law, the mandatory consultation process with
'We have carefully reviewed the situation and given the prevailing uncertainties, the goal of the plan that we are launching aims to preserve our core functions, extend our cash runway and maintain operating latitude to bring the first and only epicutaneous immunotherapy for the treatment of peanut allergy to patients in need, if approved,' said
Financial and Business Updates
As communicated on
DBV plans to focus on Viaskin Peanut and scale down other clinical programs and pre-clinical spend. The Company is contemplating the implementation of cost reduction measures across the organization, while preserving core activities and competencies. Under the revised plan and proposed cost structure, DBV now expects that its current balance of cash and cash equivalents of
Clinical Trials Update
All ongoing clinical trials will continue as planned; however, enrollment timelines have been impacted by COVID-19. The Company's global collaboration with
The Company also provided an update on the ongoing EPITOPE trial, a two-part, pivotal Phase III clinical trial assessing the safety and efficacy of Viaskin Peanut for the treatment of peanut-allergic toddlers ages 1 to 3 years, to complement the proposed indication in children ages 4 to 11 years currently under FDA review. As previously reported, Part A showed that both doses studied (100 -microg (n=20) and 250 -microg (n=21)) were reported to be well tolerated, with no treatment-related serious adverse events (SAEs). Patients in both treatment arms showed consistent treatment effect after 12 months of therapy, as assessed by a double-blind placebo-controlled food challenge and biomarker results. Part A subjects were not included in Part B and the efficacy analyses from Part A were not statistically powered to demonstrate superiority of either dose versus placebo. These results validate the ongoing investigation of the 250 -microg dose in this age group, which is the dose being studied in Part B of the study.
Based on the current COVID-19 pandemic and uncertainty surrounding study enrollment, the Company anticipates providing an update regarding sample size and expectations for completion of enrollment of Part B in the second half of 2020. The Company will evaluate potential options including adjusting the target enrollment for Part B.
'These initial data from EPITOPE, our second Phase III clinical trial for Viaskin Peanut, provide support for an epicutaneous immunotherapy approach to treating food allergy in this age group,' said
About EPITOPE
EPITOPE is expected to enroll approximately 400 patients (51 in Part A and 350 in Part B) in approximately 50 centers across
The primary endpoint is based on a responder analysis after 12 months of treatment with the selected dose of Viaskin Peanut. Efficacy will be assessed using a double-blind, placebo-controlled food challenge (DBPCFC). For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder is 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 is 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, Cumulative Reactive Dose (CRD), will also be evaluated in EPITOPE to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers will also be measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
Following the completion of EPITOPE, all eligible patients will have the option to rollover into EPOPEX, a long-term, open-label extension study of Viaskin Peanut 250 -microg. Patients enrolling in the EPOPEX study will remain blinded to their respective treatment group in EPITOPE until the EPITOPE study results become publicly available.
About
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 business and potential cost savings, the timelines for the Company's ongoing clinical trials, including in light of the ongoing impact of the COVID-19 pandemic, the potential of Viaskin Peanut as a treatment for peanut-allergic children, the conduct and timing of the Company's clinical trials of Viaskin Peanut and the Company's research, development and regulatory plans for its product candidates and preclinical pipeline, including the Company's planned interactions with the FDA regarding Viaskin Peanut and the target action date for the Company's BLA. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the products of the Company have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, including the impact of the COVID-19 pandemic, and the Company's ability to successfully execute on its restructuring plans. Furthermore, the timing of any action by the FDA and possible regulatory paths forward cannot be guaranteed. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French Autorite des Marches Financiers, the Company's
Contact:
Tel: +1 212-271-0740
Email: sara.sherman@dbv-technologies.com
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