subslover
1 month ago
DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe
Châtillon, France, October 22, 2024
DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe
DBV to pursue an Accelerated Approval pathway for toddlers ages 1 – 3 years-old
BLA submission under Accelerated Approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in Q2 2025
VITESSE Phase 3 study evaluating the Viaskin Peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; Topline results on track for 4Q 2025
European Medicines Agency (EMA) scientific advice confirms registration path for a Marketing Authorization Application (MAA) with the modified Viaskin peanut patch for a 1 – 7 year-old indication in Europe
Company to host investor conference call at 5:00pm ET today
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced positive regulatory updates for the Viaskin Peanut patch in the United States and Europe. DBV has agreed to guidance provided by the U.S. Food and Drug Administration (FDA) on a pathway under the Accelerated Approval Program for the Viaskin Peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the EMA on a 1 – 7 year-old indication in Europe. DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request.
“Our agreement with FDA guidance on a path towards Accelerated Approval for the Viaskin Peanut patch in 1 – 3 year-olds represents a significant step forward in getting this novel treatment to patients,” said Daniel Tasse, Chief Executive Officer, DBV Technologies. “I am pleased that the FDA recognizes the urgent unmet medical need that exists for this young patient population. We are also very pleased with the scientific advice received from EMA – one patch in peanut allergic children in 1 – 7 year-olds, subject to a safety study with our modified patch in toddlers 1 – 3 years-old.”
Viaskin Peanut Patch in Toddlers 1 – 3 Years
Accelerated Approval Pathway
FDA guidance for Accelerated Approval include three qualifying criteria: 1) that the product treats a serious condition, 2) that the product candidate generally provides a meaningful advantage over available therapies, and 3) that the product candidate demonstrates an effect on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
FDA confirmed that DBV has met criterion 1 and 2. Regarding criterion 3, FDA has provided guidance and suggestion regarding the intermediate clinical endpoint, which DBV has agreed to in informal discussions with the FDA. DBV intends to formalize the Accelerated Approval guidance provided by FDA via submission of a meeting request to confirm the general elements of the two study components: the COMFORT Toddlers safety study, to be completed before BLA submission, and the confirmatory effectiveness study, including the third Accelerated Approval criterion regarding the intermediate clinical endpoint. DBV expects that the confirmatory study will be initiated by the time of BLA submission and would run in parallel to commercialization in the United States, if Viaskin Peanut is approved.
COMFORT Toddlers
DBV is pleased to have aligned with FDA on a wear time collection methodology in COMFORT Toddlers that provides a practical approach for subjects and families, is intended to generate sufficient data to support a BLA submission, and places wear time into an acceptable clinical hierarchy relative to other study endpoints. DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025. The company anticipates enrolling approximately 300 - 350 subjects on active treatment into the safety study, which would bring the total Viaskin Peanut patch safety database in toddlers to approximately 600 subjects, consistent with prior FDA guidance.
With this path forward, the BLA submission for Viaskin Peanut patch in 1 – 3 year-olds under the Accelerated Approval program is anticipated to be supported by:
Positive efficacy and safety data from DBV’s previously completed EPITOPE Phase 3 Study; and
Additional safety data generated in COMFORT Toddlers supplemental safety study to be initiated in 2Q 2025.
“DBV’s Viaskin Peanut patch has the potential to significantly improve the lives of peanut allergic toddlers and their caregivers,” stated Dr. David Fleischer, FAAAAI, FACAAI, Professor of Pediatrics at Children’s Hospital Colorado. “With few approved treatment options for this patient population – the age range in which most young people are initially diagnosed with peanut allergy – the Viaskin Peanut patch has the potential to be a game changer in the food allergy community, and I look forward to having the opportunity to incorporate it into my own practice, if approved.”
Post-Marketing Confirmatory Study
DBV and FDA are in general agreement that the confirmatory study will need to demonstrate the effectiveness of the Viaskin Peanut patch and will need to be initiated at the time that the BLA is submitted. DBV will prioritize initiation of the COMFORT Toddlers safety study to enable the BLA submission.
“We are encouraged to learn that FDA has heard the voices of the food allergy community,” said Sung Poblete, PhD, RN, CEO of FARE (Food Allergy Research and Education). “This hopeful advancement in the treatment of peanut allergic toddlers has the potential to make a positive impact on the millions of families that are urgently awaiting innovative treatment options, and the confirmatory study will certainly add to the rich data that has been compiled in this important disease space. We stand by DBV in their efforts to advance Viaskin and look forward to representing the patient perspective.”
Regulatory History of the Viaskin Peanut Patch in Toddlers 1 – 3
DBV and the FDA have been engaged in ongoing dialogue regarding the COMFORT Toddlers supplemental safety study in 1 – 3 year-olds with a peanut allergy. The focus of continued exchanges has been on patch adhesion, specifically:
The hierarchy of an adhesion assessment within the COMFORT Toddlers study (FDA requesting that it be a study objective vs. exploratory assessment);
The sufficiency of adhesion data collected during the EPITOPE study to fully characterize daily patch adhesion duration (wear time) given the EPITOPE adhesion data collection methodology, and, conversely, the collection methodology required to generate sufficient adhesion data to inform the Viaskin label in future studies; and
The clinical relevance and regulatory use of adhesion data collected in a study that does not include an efficacy assessment.
DBV’s proposed labeling solution, submitted to the FDA on June 28, 2024, became critical in exploring with the FDA, practical solutions to linking adhesion, efficacy and safety to best inform the label. These fruitful discussions have led to what DBV believes to be an actionable regulatory pathway.
Viaskin Peanut Patch in Children 4 – 7
In September 2024, DBV announced that patient screening had been completed for the Phase 3 efficacy trial of the Viaskin Peanut patch in peanut allergic children ages 4 – 7 years-old (VITESSE). A total of 654 subjects were enrolled, and DBV anticipates topline data in the fourth quarter of 2025.
The COMFORT Children safety study is expected to be initiated in the second quarter of 2025. This study plans to enroll approximately 250 subjects to raise the total number of 4 – 7 year-olds on active treatment across the development program to approximately 600, consistent with prior FDA guidance. These two studies will constitute the core studies for a BLA submission in 4 – 7 year-olds.
EMA Regulatory Update
DBV sought scientific advice from the EMA regarding the components of a MAA for the Viaskin Peanut patch. Previous advice obtained from two local country regulatory health authorities indicated a potential path for a 1 – 7 year-old registration with one patch, the modified patch. The EMA recently confirmed through scientific advice that the completed EPITOPE study in 1 – 3 year-olds, and a positive VITESSE study in 4 – 7 year-olds, could constitute an MAA submission for a 1 – 7 year-old indication for peanut allergy patients using the modified patch, along with a new safety study in 1 – 3 year-olds with the modified patch. Timing for the initiation of this new safety study to satisfy the important EU market is currently being planned.
The most recent European Academy of Allergy & Clinical Immunology (EAACI) draft Guidelines on the Management of IgE-mediated Food Allergy has the following recommendation: “In children and adolescents with IgE-mediated peanut allergy, peanut epicutaneous immunotherapy is suggested to achieve desensitization, if available.” This recommendation further supports the potential clinical benefit of the Viaskin Peanut Patch, if approved, in Europe and the unmet medical need.
Financial Update
Based upon preliminary estimates and information available to the Company as of the date of this announcement, DBV’s cash and cash equivalents amount to $46.4 million as of September 30, 2024, compared to $66.2 million as of June 30, 2024, a net decrease by $19.8 million comprising :
$22.5 million of net cash flow used in operating activities, mainly external clinical-related expenses notably progress on patient enrollment in VITESSE Phase 3 clinical trial, Regulatory and Medical activities as well as Manufacturing Operations.
Partially offset by Research Tax Credit complementary refund for years 2020 to 2022 of $3.0 million.
These preliminary financial results reflect the Company’s estimates and are based on currently available information. The Company’s actual financial results for the quarter ended September 30, 2024 have not yet been finalized by management or reviewed by the Company’s independent auditors. This preliminary financial information is not a comprehensive statement of all financial results for the quarter ended September 30, 2024. Accordingly, undue reliance should not be placed on these preliminary financial results.
The Company has incurred operating losses and negative cash flows from operations since inception. As of the date of this announcement, the Company’s available cash and cash equivalents is not projected to be sufficient to support its operating plan for at least the next 12 months. As such, there is substantial doubt regarding the Company’s ability to continue as a going concern. Based on current operations, plans and assumptions, the Company expects that its balance of cash and cash equivalents will be sufficient to fund its operations into 1Q 2025 and intends to seek additional capital as it continues research and development efforts and prepares for the launch of Viaskin Peanut, if approved.
Investor Conference Call and Webcast
DBV management will host an investor conference call and webcast today, October 22nd, at 5:00pm EST, to discuss these regulatory updates. This call is accessible via the below teleconferencing numbers and requesting the DBV Technologies call.
United States: +1-877-346-6112
International: +1-848-280-6350
A live webcast of the call will be available on the Investors & Media section of the Company’s website: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.
About DBV Technologies
DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary Viaskin® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the Viaskin® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual’s underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin’s immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of Viaskin Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
subslover
2 years ago
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
December 23 2022 - 01:30AM
GlobeNewswire Inc.
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Montrouge, France, December 23, 2022
DBV Technologies Announces FDA Has Lifted Partial Clinical Hold on VITESSE Phase 3 Pivotal Trial
DBV expects to initiate patient screening in Q1 2023 with the last patient screened by 1H 2024 and topline results anticipated in 1H 2025
Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data
DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the Company’s VITESSE (Viaskin Peanut Immunotherapy Trial to Evaluate Safety, Simplicity and Efficacy) Phase 3 clinical trial that will evaluate the modified Viaskin™ Peanut 250 µg patch (DBV712) in peanut-allergic children ages 4 to 7 years. The updated protocol will be submitted to study sites for subsequent Institutional Review Boards (IRB)/Ethics Committees (EC) approval.
In the Partial Clinical Hold (PCH) letter, the FDA requested changes to certain elements of the VITESSE protocol with the intent for the trial to support a Biologics License Application (BLA). The FDA communication contained four protocol modifications: the redefinition of the minimal daily wear time, the addition of a statistical test for the patch adhesion assessment, the reclassification of certain adverse events (AEs) to adverse events of special interest (AESIs) and an increase in the number of trial participants on active treatment.
Key design elements of VITESSE such as inclusion criteria, primary efficacy endpoint, responder criteria, efficacy assessment methodology and safety endpoints were not impacted by the PCH letter and have not changed.
“We are pleased that the FDA has lifted the partial clinical hold on the VITESSE study and anticipate initiating patient screening in Q1 2023,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “I am proud of our team for continuing to advance important pre-study activities these last several weeks so that we are prepared to act quickly to re-launch VITESSE following today’s announcement.”
Following receipt of the PCH letter, DBV and the FDA discussed how VITESSE protocol modifications could best support the Agency’s review of a potential BLA for Viaskin Peanut as a peanut allergy treatment.
In lifting the PCH, the FDA confirmed DBV satisfactorily addressed all clinical hold issues identified in the PCH letter. The FDA stated that DBV may proceed with VITESSE with the following changes included in the revised protocol:
The updated VITESSE Instructions for Use (IFU) will direct caregivers to apply one patch at approximately the same time each day, following removal of the previous day’s patch. The updated IFU now outlines that Viaskin Peanut 250 µg is to be worn for as close to a full day as possible (i.e., 24 hours) with a minimum daily wear time of 20 hours each day.
Patch adhesion will be assessed in VITESSE to affirm the modified Viaskin Peanut patch performs adequately, which aligns with existing regulatory requirements for patch-based therapies. In post-PCH discussions, DBV and the FDA agreed a statistical test of adhesion will be included in the VITESSE statistical analysis plan and further considered patch adhesion data collection and interpretation in the context of the novel nature of the Viaskin patch platform.
Four AEs will be classified as AESIs. These AEs – which include AEs leading to inhaled or systemic corticosteroid or epinephrine use, systemic allergic reactions, and Grade 4 local application site (skin) reactions – were collected and assessed in all previous Viaskin Peanut trials and included in the previous VITESSE protocol. Only the classification of these AEs has changed.
DBV plans to initiate a separate safety study in approximately 275 additional subjects, randomized 3:1 active versus placebo. The additional safety data generated by this six-month study will supplement the safety data generated by the VITESSE trial, resulting in a safety database comprised of approximately 600 children ages 4 to 7 years treated with Viaskin Peanut. The protocol design of the safety study will be submitted to the FDA and is expected to be similar to the REALISE (REAL Life Use and Safety of EPIT) safety study that DBV previously conducted with Viaskin Peanut in children ages 4 to 11 years.
The Company does not expect the additional safety study to have an impact on the Company’s cash runway guidance as DBV had included a provision for a possible supplemental safety trial in its cash runway assumptions. The Company reiterates that cash on-hand is sufficient to fund operations through VITESSE topline data.
“Following a very productive dialogue with the FDA, we have incorporated the Agency’s modifications to VITESSE into the study protocol and look forward to initiating patient treatments,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “I am confident that the VITESSE study, when completed, will add to the growing body of evidence demonstrating the ability of our novel drug-device immunotherapy platform, Viaskin Peanut, to address significant unmet needs among peanut-allergic children and their families.”
DBV anticipates initiating VITESSE patient screening in the first quarter of 2023 with the last patient screened in 1H 2024 and topline results anticipated in 1H 2025.
About VITESSE
The VITESSE trial will enroll 600 subjects, randomized 2:1 active versus placebo. The study will involve approximately 80 trial sites across the United States, Canada, Australia and Europe. Dr. David Fleischer, Children’s Hospital Colorado, will act as the principal investigator.
The primary efficacy endpoint is the percentage of treatment responders in the active versus placebo arms at Month 12. The primary efficacy analysis includes the success criterion of a lower bound of the confidence interval of the difference in responder rates between active and placebo groups being greater than or equal to 15%.
A treatment responder is defined as either a subject with a baseline eliciting dose (ED) ≤30 mg who reaches an ED ≥300 mg of peanut protein at Month 12, or a subject with a baseline ED = 100 mg who reaches an ED ≥600 mg of peanut protein at Month 12. A double-blind, placebo-controlled food challenge (DBPCFC) will be administered at baseline and Month 12 to determine a subject’s ED at both timepoints.
During the screening period, subjects will undergo an initial visit with assessment for eligibility according to peanut skin prick test (SPT) and serum peanut IgE. Those meeting these criteria will proceed to a DBPCFC to confirm their peanut allergy and establish an entry peanut ED. The entry DBPCFC will be 1 mg peanut protein, and will escalate up to a highest single dose of 100 mg peanut protein. Subjects who react with an ED at or below the dose of 100 mg peanut protein are considered eligible. At Month 12, a post-treatment DBPCFC will be performed, with a starting dose of 3 mg peanut protein, escalating to a highest dose of 1,000 mg peanut protein according to the following schedule: 3, 10, 30, 100, 300, 600, 1,000 mg. Secondary efficacy endpoints include changes in Cumulative Reactive Dose, ED and severity of allergic reaction at Month 12 food challenge.
BostonSportsNut
5 years ago
DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
PRESS RELEASE GlobeNewswire
Aug. 7, 2019, 04:05 PM
Montrouge, France, August 7, 2019
DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. Viaskin Peanut is the Company’s lead product candidate based on epicutaneous immunotherapy (EPIT®). Viaskin is the Company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization to allergens.
This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission for Viaskin Peanut. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut in December 2018.
“This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients.I want to thank the team for their dedication in working to address the FDA’s findings over the past few months. Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process.”
Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase I studies, four Phase II studies and two Phase III studies. The two double-blind placebo-controlled Phase III trials, PEPITES and REALISE, studied patients aged 4 to 11 years for 12 months and 6 months, respectively, and were included in the submission. Additionally, supportive long-term data from the Company’s open-label Phase II program were also included in the submission.
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