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Astellas' Gene Therapy Trial Hit With Another Death, FDA Slaps Clinical Hold

  • Astellas Pharma Inc (OTC: ALPMF) has seen the fourth death in its experimental gene therapy trial gained through a $3 billion buyout of Audentes Therapeutics Inc.
  • The Aspiro trial was testing AT132, gene therapy for a rare neuromuscular disease, X-linked Myotubular Myopathy (XLMTM). But the trial has been hit by three deaths, leading to a clinical hold (this was lifted by the FDA late last year).
  • After one patient reported abnormal liver function test results earlier this month, Astellas was forced to pause screening and dosing of additional participants.
  • Related Content: See Why Astellas Stopped Dosing In Neuromuscular Disease Gene Therapy Trial.
  • Today, the Japanese pharma said that this patient has now died. It did not give a cause of death. The FDA informed Astellas that the ASPIRO trial had been placed on clinical hold, and a written letter is expected over the next several weeks. 
  • “Astellas is gathering the relevant clinical information and incorporating such information into the ongoing investigation regarding other serious adverse events observed to date in the Aspiro trial,” the company said in a statement. 
  • “This was the first and only participant dosed following the December 23, 2020, release of the earlier FDA clinical hold.”
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: ALPMF stock closed at $17.10 on Monday.

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