The Type A meeting request was submitted following the Company's receipt of a Complete Response Letter (CRL) in connection with its Biologics License Application (BLA) for Viaskin Peanut (DBV712), an investigational, non-invasive, once-daily epicutaneous patch to treat peanut allergy in children ages 4 to 11 years.
DBV believes that the feedback received from the FDA provides a well-defined regulatory path forward. In exchanges with the FDA, DBV proposed potential resolutions to two main concerns identified by the FDA in the CRL: the impact of patch adhesion and the need for patch modifications. DBV will address details about a new human factor (HF) validation study and additional chemistry, manufacturing and controls (CMC) data in subsequent interactions with the FDA.
The FDA agreed with DBV's position that a modified Viaskin Peanut patch should not be considered as a new product entity provided the occlusion chamber of the current Viaskin Peanut patch and the peanut protein dose of 250 -microg (approximately 1/1000 one peanut) remains unchanged and performs in the same way it has performed previously.
In order to confirm the consistency of efficacy data between the existing and modified patches, FDA has requested an assessment comparing the uptake of allergen (peanut protein) between the patches in peanut allergic children ages 4-11. The FDA also recommended conducting a 6-month, well-controlled safety and adhesion trial to assess the modified Viaskin Peanut patch in the intended patient population.
DBV plans to initiate the selection of modified prototype patches in the first quarter of 2021. Additionally, DBV will submit the protocol for the safety and adhesion trial in children with peanut allergy to FDA for review and comments in the second quarter of 2021 before initiating the trial.
'We are very encouraged by the positive feedback received from the FDA, and we appreciate the clarity provided,' stated
'We look forward to working with our investigators, clinical trial sites, and key stakeholders as we continue in our development of investigational Viaskin Peanut,' said Dr.
Based on the guidance received from the FDA and DBV's plans to implement such guidance, DBV continues to expect that the organization-wide cost reduction measures resulting from its previously announced global restructuring plan will extend its cash runway to the second half of 2022.
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Forward Looking Statements
This press release may contain forward-looking statements and estimates, including statements regarding the design of DBV's anticipated clinical trials, the anticipated timeline for regulatory submissions and trial initiation, potential future interactions with the FDA, the potential benefits of Viaskin Peanut DBV's continued development of epicutaneous immunotherapy the implementation of DBV's global restructuring plan, potential cost savings anticipated from the global restructuring plan, and DBV's forecast of its cash runway. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, the Company's products 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 are risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as to DBV's ability to meet other anticipated deadlines and milestones, presented by the ongoing COVID-19 pandemic; uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; risks related to whether results from a clinical trial will be predictive of the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of DBV's product candidates; expectations for regulatory approvals to conduct trials or to market products and DBV's ability to successfully execute on its restructuring plans. Furthermore, the timing of any action by any regulatory agency cannot be guaranteed, particularly in light of the COVID-19 pandemic. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV's regulatory filings with the French Autorite des Marches Financiers, DBV's
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