Montrouge, France, December 20 (10:15 p.m. CET) 2021
DBV Technologies takes stock of
regulatory changes in
Viaski
n ™
Peanut
DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced its intention to start a new pivotal phase 3 study of the modified patch Viaskin ™ Peanut in children in the target patient population. The Company has also published an update regarding the Marketing Authorization Application for ViaskinPeanut filed with the European Medicines Agency (EMA).
Update on the American regulatory dossier
:
DBV has notified the US Food and Drug Administration (FDA) of its intention to initiate a new pivotal phase 3 clinical study of the modified ViaskinPeanut patch in children in the target patient population. The study will focus on the modified ViaskinPeanut (mVP) patch, which is circular in shape and approximately 50% larger than the current ViaskinPeanut (cVP) patch. In the CHAMP study, carried out in a cohort of healthy adults, mVP outperformed cVP. The new pivotal study will also include updates to the Instructions For Use (IFU).
At the end of November 2021, DBV received recommendations and requests for information from the FDA regarding the evaluation of the allergen absorption / transport comparability between mVP and cVP. Upon review of these submissions, it is clear that further discussion with the FDA will be required before DBV can initiate the allergen uptake comparison study between mVP and cVP. As previously announced, the FDA informed DBV in October 2021 that it would provide additional comments on the design of the STAMP protocol, only after reviewing the data from the allergen absorption / transport comparability study.
After careful analysis of the FDA’s requests for information and consideration of all other options, the Company has decided not to pursue the sequential approach for the development plan of ViaskinPeanut (absorption / transport study of the allergen before STAMP) as requested by the FDA in its October 2021 return. DBV had planned to carry out these studies in parallel. DBV estimates that adopting the FDA’s newly proposed sequential approach would require at least five cycles of trade requiring alignment with the FDA prior to the initiation of STAMP, a six-month safety and adherence study. DBV believes that this approach is not in the best interests of patients, due to the long delays associated with the review by the FDA of a product dependent on the resources available to the United States Agency (product not falling under the “Prescription Drug User Fee Act”, PDUFA).
Therefore, DBV believes that the completion of a new pivotal phase 3 placebo-controlled clinical study, similar to PEPITES (V712-301), is the most direct and effective means for the progression and advancement of the regulatory pathway of ViaskinPeanut. DBV also considers this approach to be the most straightforward to demonstrate effectiveness, safety and improved grip.
invivo
of the modified ViaskinPeanut system. The FDA confirmed that DBV’s change in strategy was acceptable in its oral and written discussions.
DBV has started work on a protocol for the placebo-controlled phase 3 efficacy study with mVP, and will seek agreement with the FDA before the initiation of the new trial. The Company is in the process of finalizing the new protocol for the pivotal phase 3 study and intends to submit this protocol to the FDA by the end of February 2022.
”
DBV is convinced that a new pivotal phase 3 study, generating a robust data set, is the best way to support the development of Viaskin
Peanut
“,
said DanielTassé, CEO of DBVTechnologies. ”
In October we were surprised
to see the FDA request a sequential approach to our development plans
. take in account the
recommendations and
requests for information received from the FDA regarding STAMP in October and the study
d
‘absorption/
of
transport of the
‘allergen
in November, the Company estimated that
from
trades
additional
with the FDA
,
in the context of review deadlines related to resource dependence
,
would be unpredictable and
would likely cause significant delays in
our
advances
regulatory. We are convinced that Viaskin
Peanut
is a viable treatment option for patients currently suffering from
cared for
and who are eagerly awaiting treatment options. Our priority is to provide them with a safe, efficient and convenient product as quickly as possible. ”
Update on the European regulatory dossier
:
DBVTechnologies announced today that it has officially notified the European Medicines Agency (EMA) of its decision to withdraw the Marketing Authorization (MA) application for ViaskinPeanut. The application for ViaskinPeanut had been accepted by the EMA in November 2020. At the time of the withdrawal, the product was under review by the EMA’s Committee for Medicinal Products for Human Us (CHMP).
The initial filing was supported by positive data from a single pivotal phase 3 trial, PEPITES (V712-301). The withdrawal decision was based on the current opinion of the CHMP that the data available to date from a single pivotal study in the Marketing Authorization was not sufficient to avoid, on day 180 of the review process, a major objection. As noted above, the Major objection concerns the scope of the data, for example, clinical relevance and magnitude of effect. DBV believes that the generation of data from a new pivotal phase 3 trial will pave a more robust path for the approval of Viaskin Peanut in the European Union.
”
DBV’s decision to withdraw MA for Viaskin
Peanut
is the result
an in-depth reflection aimed at submitting the most solid request
possible
for Union patients
European
Said PharisMohideen, medical director of DBV Technologies. “Our
team has demonstrated thoughtfulness and analysis in designing a new pivotal Phase3 trial protocol to support US and European regulatory pathways, and we will continue to work closely with the EMA as we go forward. as we
will produce
additional data. There is a significant need for effective and well-tolerated treatments for people with peanut allergies, and our goal is to offer Viaskin
Peanut
to patients and physicians as quickly as possible
. ”
DBV will host a live audio conference call and webcast on Monday, December 20, 2021 at 11:00 p.m. CET to provide an update on its activities
This conference will be accessible by dialing the conference numbers below, followed by the reference ID: 50269344.
United States: (866) 939-3921
Canada: (866) 215-5508
United Kingdom: 0808 238 9578
France: 0805 102 604
A live webcast of the conference will be available in the “News and Resources” section of the Company’s website at: https://www.dbv-technologies.com/en/news-and-resources/. A replay of the presentation will also be available on the DBV website once the event is over.
About DBV Technologies
DBV Technologies is developing Viaskin ™, an exclusive experimental technological 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 non-invasive product candidates, the Company aims to safely transform the treatment of patients with food allergies. DBV’s food allergy programs include ongoing clinical trials with Viaskin Peanut. DBV Technologies’ global headquarters is located in Montrouge, France, and its North American operations are based in Summit, New Jersey. The company’s ordinary shares are traded on the B segment of Euronext Paris (symbol: DBV, ISIN code: FR0010417345) and the company’s ADSs (each representing half an ordinary share) are traded on the Nasdaq Global Select Market ( symbol: DBVT).
Forward-looking statements
This press release may contain forward-looking statements and estimates, including statements relating to regulatory and clinical efforts planned by DBV, including the timing and results of communications with regulatory agencies, and the ability to any DBV product candidate, if approved, will improve the lives of patients with food allergies. These forward-looking statements and estimates do not constitute promises or guarantees and involve substantial risks and uncertainties. At this point, DBV’s product candidates have not been authorized for sale in any country. Factors that cause actual results to differ materially from those described or projected in this document include uncertainties generally associated with research and development, clinical trials, and related regulatory reviews and approvals, including the impact of the COVID-19 pandemic. A more detailed list and description of the risks and uncertainties that could cause actual results to differ materially from those stated in the forward-looking statements of the
Contact with investors
Anne Pollak
DBV Technologies
+1 857-529-2363
[email protected]
Media contact
Angela Marcucci
DBV Technologies
+ 1646-842-2393
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