TOKYO, September 14, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) reports that the ASPIRO clinical trial participant, who developed a serious adverse event as described on September 1, passed away on September 9. The cause of death is still pending.

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. This was the first and only participant dosed following the December 23, 2020, release of the earlier FDA clinical hold. 
 
On September 1, Astellas announced that it had paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy (XLMTM). Thereafter, the FDA informed Astellas via email that the ASPIRO trial had been placed on clinical hold and a written letter is expected over the next several weeks.  Following receipt of the official FDA clinical hold letter, Astellas will review its contents and have further dialogue with regulators on the path forward. 
 
“On behalf of Astellas, we extend our deepest sympathies to the participant’s family, said Nathan Bachtell, M.D., Senior Vice President and Head of Gene Therapy, Medical & Development at Astellas.  “We will investigate and review all findings with our independent data monitoring committee, our expert liver advisory panel and the ASPIRO site investigators. We remain committed to the development of AT132 and the XLMTM patient community.”

 

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