RTTNews | Sep 1, 2021 02:53AM EDT

02:52 Wednesday, September 1, 2021 (RTTNews.com) - Astellas Pharma Inc. (ALPMY, ALPMY) said Wednesday that it has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy.

The move came after the reporting of a recent serious adverse event in a study participant due to abnormal liver function tests observed in the weeks following dosing of the AT132 investigational gene therapy product at a lower dose.

The company said the participant has a history of intermittent cholestasis. However, prior to dosing, the participant had a normal liver ultrasound; and the participant's liver function tests, were within eligibility criteria. The company will continue to closely monitor the participant's status.

X-linked Myotubular Myopathy is a serious, life-threatening, rare neuromuscular disease that is characterized by extreme muscle weakness, respiratory failure and early death.

Astellas said it has reported the serious adverse event to regulatory agencies, and is engaged in dialogue with regulators about the serious adverse event.

At this time, an Investigational New Drug clinical hold has not been issued by the U.S. Food and Drug Administration. If the company receives a clinical hold letter, it will review the content and determine next steps, Astellas Pharma said in a statement.

Read the original article on RTTNews ( https://www.rttnews.com/3222397/astellas-pharma-halts-rare-neuromuscular-clinical-trial-due-to-serious-adverse-event.aspx)

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