A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy With DBV712 250 μg in 4-7-year-old Children With Peanut Allergy (VITESSE)

The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month treatment period.

开始日期2023-03-22

申办/合作机构

DBV Technologies SA

EUCTR2018-003323-10-DE / Unknown status临床3期

EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX) - EPOPEX

开始日期2021-02-11

申办/合作机构-

NCT03859700 / Enrolling by invitation临床3期

EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children

Open-label, follow-up study for subjects who completed the EPITOPE study.

开始日期2018-12-06

申办/合作机构

DBV Technologies SA

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项与 Peanut allergy immunotherapy(DBV Technologies SA) 相关的文献（医药）

2024-02-07·Expert review of clinical immunology

Safety and efficacy of epicutaneous immunotherapy with DBV712 (peanut patch) in peanut allergy.

Review

作者: Christophe Dupont ; A Wesley Burks ; David M Fleischer ; Katharine J Bee ; Sarita Chainani ; Hugh A Sampson

INTRODUCTION:

DBV712 250 µg, (also referred to as Viaskin Peanut or peanut patch; Viaskin is a trademark of DBV Technologies), is an innovative approach to epicutaneous immunotherapy (EPIT). The patch-based technology system facilitates peanut protein (allergen) absorption into the intact non-vascularized epidermis to promote desensitization to peanut while limiting systemic allergen exposure.

AREAS COVERED:

Efficacy and safety in children have been evaluated in four completed phase 3 studies. Overall, the results from these studies have demonstrated the peanut patch to be superior in desensitization compared with placebo and safe for daily use over multiple years.

EXPERT OPINION:

These findings, as well as supportive evidence from phase 2 studies, confirm the potential for an effective treatment of peanut allergy in children. The purpose of this review is to summarize the safety and efficacy of the peanut patch in the treatment of peanut allergy.

2024-01-01·Immunotherapy

Epicutaneous immunotherapy with Viaskin^™ Peanut in toddlers: a plain language summary.

Review

作者: David R Stukus ; Ruchi Gupta ; Douglas Mack ; Lianne Mandelbaum ; Dareen Siri ; Vivian Hernandez-Trujillo ; Hugh A Sampson

WHAT IS THIS SUMMARY ABOUT?:

This is a summary of an article published in The New England Journal of Medicine about the EPITOPE clinical study, which tested a skin patch called ViaskinTM Peanut 250 μg (micrograms) as a treatment option for peanut allergy in children aged 1 through 3 years. The patch is a form of epicutaneous immunotherapy (EPIT), which is a new approach to allergen immunotherapy that delivers a small amount of peanut protein to the immune system through the skin. Viaskin Peanut is an investigational therapy, meaning it has not yet been approved by the United States Food and Drug Administration (FDA), that has been studied before in young children aged 4 through 11 years. In those studies, the children who received the patch were desensitized and were less likely to experience anaphylaxis when they ate peanut at the end of the study. The EPITOPE study included children aged 1 through 3 years with peanut allergy and looked at how well the peanut patch worked and how safe it was compared to a patch with no medicine (placebo, no medicine) after 12 months.

WHAT WERE THE KEY TAKEAWAYS?:

The study showed that the peanut patch was better in desensitizing children to peanuts than the placebo patch. Most of the children in the study who received the peanut patch for 12 months (the treatment group) were able to eat and tolerate more peanut at the end of the study than those who received only the placebo patch (the control group). This demonstrates that the children in the treatment group were less likely to have an allergic reaction if they ate peanut by accident at the end of the study. The children in the treatment group also had less severe symptoms when they were given peanut during the oral food challenges at the end of the study. Most children in both groups experienced side effects. Mild to moderate local skin reactions where the patch was applied were most common. These side effects happened less often and were less serious over the 12-month treatment period.

WHAT WERE THE MAIN CONCLUSIONS REPORTED BY THE RESEARCHERS?:

Overall, these results show the peanut patch may be a possible treatment option to help desensitize young children with peanut allergy to peanut.

2023-03-14·Allergy

Immune Response Evolution in Peanut Epicutaneous Immunotherapy for Peanut-Allergic Children.

Article

作者: Marie Bastin ; Warner W Carr ; Carla M Davis ; David M Fleischer ; Jay A Lieberman ; S Shahzad Mustafa ; Thibault Helleputte ; Timothée Bois ; Dianne E Campbell ; Todd D Green ; Matthew Greenhawt

BACKGROUND:

Epicutaneous immunotherapy (EPIT) with investigational Viaskin™ Peanut 250 μg (DBV712) has demonstrated statistically superior desensitization versus placebo in peanut-allergic children in clinical trials. It is unclear if serologic biomarkers predict response.

METHODS:

Serum-specific IgG4 and IgE (whole peanut and components) from subjects enrolled in the phase 3 PEPITES study were examined by exploratory univariate and multivariate analyses to determine trajectories and predictors of treatment response, based upon peanut protein eliciting dose (ED) at Month (M) 12 double-blind placebo-controlled food challenge.

RESULTS:

Among Viaskin Peanut-treated subjects, peanut sIgG4 significantly increased from baseline through M12 and peanut sIgE peaked at M3 and fell below baseline by M12, with sIgG4 and sIgE peanut components mirroring these trajectories. Placebo subjects had no significant changes. By univariate analysis, M12 peanut sIgG4/sIgE was higher in treatment responders (P < 0.001) and had highest area under the curve (AUC) for predicting ED ≥300 mg and ≥1000 mg (AUC 69.5% and 69.9%, respectively). M12 peanut sIgG4/sIgE >20.1 predicted M12 ED ≥300 mg (80% positive predictive value). The best performing component was Ara h 1 sIgE <15.7 kU_A /L (AUC 66.5%). A multivariate model combining Ara h 1 and peanut sIgG4/sIgE had an AUC of 68.2% (ED ≥300 mg) and 67.8% (ED ≥1000 mg).

CONCLUSIONS:

Peanut sIgG4 rise most clearly differentiated Viaskin Peanut versus placebo subjects. sIgG4/sIgE ratios >20.1 and the combination of Ara h 1 and peanut sIgG4/sIgE had moderate ability to predict treatment response and could potentially be useful for clinical monitoring. Additional data are needed to confirm these relationships.

项与 Peanut allergy immunotherapy(DBV Technologies SA) 相关的新闻（医药）

2024-03-14

·药融圈

创新企业！Epitomee向FDA递交减肥胶囊上市申请

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：Epitomee MedicalEpitomee® (TASE：EPIT) 近期宣布，公司已于 2024 年 2 月 27 日提交其减肥胶囊供美国食品药品管理局 (FDA) 批准，是该公司研发过程中的重要里程碑。Epitomee® 胶囊为希望减肥的成年人提供创新、口服、不含药物、经临床验证有效且安全的解决方案。建议的适应症涵盖最广泛的体重指数 (BMI) 范围，即 25 至 40 kg/m2；即便没有并存疾病，在配合饮食和运动的情况下，可达到最佳效果。本次申请通过针对医疗器械的 510k 监管途径进行提交。值得注意的是，Epitomee® 胶囊已经获得欧盟的批准并带有 CE 标志。一旦经美国食品药品管理局批准，该胶囊将可通过医疗保健专业人员的处方获得。世界肥胖联合会前主席 Donna Ryan 教授说："Epitomee® 胶囊是显著改善体重管理的工具。它是治疗超重和肥胖的方法，有效而安全，可加强减肥成效并改善生活质量；不但有望预防糖尿病前期患者的糖尿病恶化，还有助改善血压、血脂和腰围。鉴于其出色的安全记录，良好的风险收益比突显了其作为广泛应用可行选择的重要性，"Epitomee Medical 首席执行官 Dan Hashimshony 博士说："我们很高兴地宣布向 FDA 提交减肥胶囊数据。这是在美国实现商业化的又一步骤。我们渴望在不久的将来，向医疗保健专业人员和消费者介绍这项突破性的创新，并通过更多的全球商业合作伙伴关系扩大我们的市场范围。"本公告是在该公司宣布（2024年1月16日）成功完成 RESET 关键临床试验（随机、安慰剂对照、双盲试验）之后发布，该试验调查了 Epitomee® 胶囊与假胶囊对照的安全性和有效性，以及生活方式管理对无合并症的超重或肥胖成年人减轻体重的作用。关于 Epitomee®：Epitomee® 是一家领先的健康解决方案公司，致力于推动创新的治疗方法。通过重视健康、效果和提升生活质量，Epitomee® 有望在转型医疗解决方案领域获得成功。版权声明：本文转自药融投资，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 8月 • 第六届CMC-China博览会关键词：生物药、小分子创新药、药学CMC&创新&CXO、原辅包（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

临床研究申请上市

2024-03-08

·FierceBiotech

Food allergy biotech DBV is running out of cash, with phase 3 trials underway

DBV Technologies hopes to complete enrollment in two supplemental safety trials of a peanut allergy therapy this year. DBV Technologies, a French biotech working on a treatment for food allergies, says it's running out of cash. The disclosure came via a going concern note in the company’s fourth-quarter and full-year 2023 earnings report on Friday, with DBV saying it doesn’t have enough money to keep the lights on for a full 12 months. DBV says it has until the very end of the year based on the $141.4 million in cash reported as of the end of December 2023. To persevere, the biotech will look to raise more money via debt and equity offerings. DBV’s cash reserves fell by nearly $68 million in 2023, with most of the money going toward R&D. Much of the biotech’s focus centers on lead peanut allergy treatment DBV712, with two phase 3 safety trials ongoing in kids. The goal is to complete enrollment in two supplemental six-month safety trials this year, despite experiencing delays that were attributed to new clinical trial rules in Europe. “We expect good momentum regarding Vitesse recruitment in the next several months and last subject screened by Q3 2024,” DBV CEO Daniel Tassé said in a release. The late-stage development work makes DBV’s current cash crunch all the more perilous, given how close the company potentially is to the market. In addition to wrapping up enrollment in the two COMFORT trials, DBV expects to have three-year data from an efficacy trial in toddlers 1-3 years old. A sibling trial for kids 4-7 years old is slated to screen its last patient by the third quarter of 2024. That study, named VITESSE, was previously on an FDA partial hold while the company and regulators worked on an updated trial protocol. Should DBV strengthen its balance sheet, there are two additional phase 2 trials waiting in the wings for runner-up med DBV135, which is in development for milk allergies and eosinophilic esophagitis.

临床3期临床2期

2024-03-08

·GlobeNewswire-Health Care

DBV Technologies announces filing of 2023 Annual Report on Form 10-K and Universal Registration Document

Montrouge, France, March 8, 2024 DBV Technologies announces filing of 2023 Annual Report on Form 10-K and Universal Registration Document DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the “Company”), today announced the filing, for the year ended December 31, 2023, of its Annual Report on Form 10-K with the U.S. Securities and Exchange Commission (“SEC”) and its Universal Registration Document (“URD”) with the French market authority, “Autorité des Marchés Financiers” (“AMF”). These documents can be accessed on the Investors section of the Company's website at www.dbv-technologies.com. In addition, the URD is available on the AMF’s website at www.amf-france.org and the Form 10-K is available on the SEC’s website at www.sec.gov. Printed copies of both documents are available, free of charge, at the Company’s headquarters and registered office located at 177-181 avenue Pierre Brossolette 92120 Montrouge, France. 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 technology platform, Viaskin™, 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 platform 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). DBV Technologies is headquartered in Montrouge, France, with North American operations in Basking Ridge, NJ. The Company’s ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing one-half of one ordinary share) are traded on the Nasdaq Global Select Market (Ticker: DBVT). For more information, please visit www.dbvtechnologies.com and engage with us on X (formerly Twitter) and LinkedIn. Viaskin and EPIT are trademarks of DBV Technologies. Investor Contact Katie MatthewsDBV Technologieskatie.matthews@dbv-technologies.com Media ContactAurora KrauseDBV Technologiesaurora.krause-ext@dbv-technologies.com Attachment PDF Version

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研发状态

适应症	最高研发状态	国家/地区	公司
花生过敏	申请上市	欧盟更多	DBV Technologies SA 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01675882 (CTgov)	临床2期	花生过敏	221	Viaskin Peanut (Viaskin Peanut 50 μg)	積窪簾繭憲壓淵築鬱製(遞壓範鏇餘繭廠築窪膚) = 壓鬱艱鏇膚糧範糧願簾糧鑰衊鑰顧積淵壓衊範 (範範繭遞壓艱構範壓壓, 範餘積艱餘鹹鑰廠積簾 ~ 糧築醖鏇繭構衊簾衊構) 更多	-	2021-10-27
				Viaskin Peanut (Viaskin Peanut 100 μg)	積窪簾繭憲壓淵築鬱製(遞壓範鏇餘繭廠築窪膚) = 繭選簾窪窪選選積憲構糧鑰衊鑰顧積淵壓衊範 (範範繭遞壓艱構範壓壓, 獵顧網蓋衊範鏇築鏇鏇 ~ 壓繭糧鹹製製蓋衊遞顧) 更多
NCT01955109 (CTgov)	临床2期	花生过敏	171	Viaskin Peanut (VIPES Initial Treatment Group: All Viaskin Peanut Doses)	廠鹽選積壓膚鬱艱鹽廠(簾鹹廠壓衊積製範鬱憲) = 範簾憲顧願願鏇鏇艱膚簾艱網顧構鑰範醖鹹餘 (夢醖願構繭簾構顧膚鹹, 壓願淵築觸壓膚衊鑰醖 ~ 衊衊遞衊衊築範願廠壓) 更多	-	2022-06-30
				Placebo (VIPES Initial Treatment Group: Placebo)	廠鹽選積壓膚鬱艱鹽廠(簾鹹廠壓衊積製範鬱憲) = 衊網鹽齋簾夢醖獵鹹鹹簾艱網顧構鑰範醖鹹餘 (夢醖願構繭簾構顧膚鹹, 鏇顧糧憲淵觸壓積膚餘 ~ 製鑰鏇鑰築觸膚鏇鹽衊) 更多
NCT03013517 (PEOPLE, Pubmed \| J Allergy Clin Immunol Pract) 人工标引	临床3期	花生过敏	198	DBV712	(膚築糧範簾顧網積獵壓) = 築醖蓋窪淵簾鑰製壓膚網顧壓艱糧廠範鬱齋膚 (艱積窪蓋蓋構獵襯願獵 ) 更多	积极	2020-10-01
NCT02636699 (CTgov)	临床3期	花生过敏	356	Placebo	構鑰製簾鑰襯夢遞膚選(醖築構夢鹽齋顧構淵觸) = 窪鑰鏇遞憲齋網淵衊憲網衊築繭鬱鏇壓淵糧網 (廠壓夢艱衊鑰築願觸鏇, 鬱餘艱壓夢壓膚醖鹽築 ~ 窪艱憲鏇願製餘構蓋窪) 更多	-	2021-10-15
NCT01904604 (CTgov)	临床2期	花生过敏	75	Placebo Viaskin® Patch (Placebo Patch)	蓋鹽網齋襯醖夢憲窪鬱(構遞鹽選醖蓋衊觸鹹願) = 鑰窪蓋願憲構範襯製襯簾製衊遞憲獵鹹範獵積 (簾壓餘廠願選範鏇膚簾, 鑰顧餘糧膚餘積夢糧觸 ~ 獵壓製鹽遞壓簾積鬱網) 更多	-	2016-08-26
				Low-dose DBV712 Viaskin® Patch (100 µg Peanut Patch)	蓋鹽網齋襯醖夢憲窪鬱(構遞鹽選醖蓋衊觸鹹願) = 鑰顧襯簾糧壓顧製夢簾簾製衊遞憲獵鹹範獵積 (簾壓餘廠願選範鏇膚簾, 製鏇鹽醖簾鬱衊艱餘餘 ~ 蓋觸顧鬱窪簾鹹鬱築壓) 更多
NCT03211247 (EPITOPE, GlobeNewswire) 人工标引	临床3期	花生过敏	362	Peanut allergy immunotherapy	(憲繭選積製艱蓋繭積簾) = 糧積艱鏇淵鑰鏇鹽願憲網鬱繭繭鹹齋選淵鹹壓 (構鏇窪醖顧糧鹹膚遞範 ) 更多	积极	2022-06-07
				Placebo	(憲繭選積製艱蓋繭積簾) = 蓋網繭襯窪齋艱獵鑰鏇網鬱繭繭鹹齋選淵鹹壓 (構鏇窪醖顧糧鹹膚遞範 ) 更多