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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宣佈EPITOPE第三階段開放標籤擴展研究的三年結果;數據提供了支持,顯示持續使用VIASKIN花生治療的患者在各項療效參數上經過36個月的治療後有明顯改善。
Benzinga ·  01/09 05:08
  • 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數據顯示,VIASKIN花生貼片對1至3歲幼兒的治療效益在36個月內持續改善。
  • 68.2%的受試者在口服食物挑戰中完成(約12-14顆花生)而未達到停止標準,12個月時爲30.7%
  • 在EPITOPE OLE的第三年中,沒有發生與治療相關的過敏反應或嚴重的治療相關不良事件(TEAE)
  • DBV還公佈了EPITOPE每日貼片佩戴時間的數據,支持公司與FDA分享的提議標籤方案。
  • DBV將在2025年1月9日至12日在佛羅里達州棕櫚灘舉行的東部食品過敏與共病會議上,通過多個摘要展示這些數據。
    • 公司將在今日東部時間下午5:00舉辦投資者網絡研討會
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