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DBV Technologies Announces 3-Year Results From EPITOPE Phase 3 Open-Label Extension Study; Data Provided Support That Continued Treatment With VIASKIN Peanut Showed Improveemntn Through 36 Months Of Treatment Across All Efficacy Parameters

DBV Technologies Announces 3-Year Results From EPITOPE Phase 3 Open-Label Extension Study; Data Provided Support That Continued Treatment With VIASKIN Peanut Showed Improveemntn Through 36 Months Of Treatment Across All Efficacy Parameters

DBV Technologies宣布EPITOPE第三阶段开放标签扩展研究的三年结果;数据提供了支持,显示持续使用VIASKIN花生治疗的患者在各项疗效参数上经过36个月的治疗后有明显改善。
Benzinga ·  01/08 16:08
  • EPITOPE OLE data demonstrates continued improvement in treatment benefit of VIASKIN Peanut patch in toddlers 1 – 3 years through 36 months
  • 68.2% of subjects completed the oral food challenge (~12-14 peanut kernels) without meeting stopping criteria, compared to 30.7% at month 12
  • No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three of EPITOPE OLE
  • DBV also announced daily patch wear time data from EPITOPE that is supportive of the Company's proposed labeling approach shared with FDA
  • DBV to highlight these data in multiple abstract presentations at the Eastern Food Allergy & Comorbidity Conference, January 9-12, in Palm Beach, Florida
    • Company to host investor webcast today at 5:00pm ET
  • EPITOPE OLE数据显示,VIASKIN花生贴片对1至3岁幼儿的治疗效益在36个月内持续改善。
  • 68.2%的受试者在口服食物挑战中完成(约12-14颗花生)而未达到停止标准,12个月时为30.7%
  • 在EPITOPE OLE的第三年中,没有发生与治疗相关的过敏反应或严重的治疗相关不良事件(TEAE)
  • DBV还公布了EPITOPE每日贴片佩戴时间的数据,支持公司与FDA分享的提议标签方案。
  • DBV将在2025年1月9日至12日在佛罗里达州棕榈滩举行的东部食品过敏与共病会议上,通过多个摘要展示这些数据。
    • 公司将在今日东部时间下午5:00举办投资者网络研讨会
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