Shots:
- Astellas discontinue the dosing in the ASPIRO trial that evaluates AT132 in 24 participants (7 at the 1.3×1014 vg/kg dose and 17 at the 3.5×1014 vg/kg dose) with XLMTM. The participant has a history of intermittent cholestasis
- The discontinuation is due to serious AEs in a study that demonstrated abnormal LFTs in patients who received a low dose of AT132. Additionally, 3 patients develops progressive cholestatic hepatitis & liver failure who treated at 3.5×1014 vg/kg dose
- In Dec’20, FDA lifted the hold after reviewed the modifications to ASPIRO trial protocol including a reduction of dosing. AT132 has received RMAT, RPD designation, FTD & ODD from the FDA while PRIME & ODD from EMA
Click here to read full press release/ article | Ref: Astellas | Image: Nasdaq
The post Astellas Pauses Dosing of AT132 in ASPIRO Clinical Trial for the Treatment of X-linked Myotubular Myopathy first appeared on PharmaShots.
