シンバイオ製薬---注射剤ブリンシドフォビルによる第2a相臨床試験においてFPI(第1例目)を達成

2024年06月12日 10:28:00
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*10:28JST シンバイオ製薬---注射剤ブリンシドフォビルによる第2a相臨床試験においてFPI(第1例目)を達成シンバイオ製薬<4582>は11日、米国において実施中の造血幹細胞移植後のサイトメガロウイルス感染症(以下、CMV感染症)患者を対象とした注射剤ブリンシドフォビル(brincidofovir、以下「BCV」)の第2a相臨床試験(以下、同試験)において第1例目が、2024年6月10日(米国中部時間)に登録されたと発表。
同試験は、現在実施中の免疫不全状態のアデノウイルス感染症を対象とした第2a相試験においてプロトコル変更を行い追加適応症として、米国食品医薬品局(FDA)に本年2月に受理されたことによりCMV感染症を新たに対象としたもの。
造血幹細胞移植後のCMV感染症については、造血幹細胞移植後のウイルス感染の中で発症率は最も高く、既に予防薬あるいは治療薬はあるものの再活性化例や耐性・不応例が多く認められており患者数も多く、未充足の治療領域であることから医療ニーズが高い感染症である。
Chimerixが実施した経口剤BCVの臨床試験において、BCVがCMV感染症に対して高い有効性を示す結果が既に得られており、安全性の高い注射剤BCVによる臨床試験を開始する。

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