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PTC Therapeutics Inc PTCT confirmed that enrollment is active and ongoing for its Phase 2 PIVOT-HD trial of PTC518 for Huntington’s disease at study sites globally.
The Phase 2 PIVOT-HD study consists of two parts:
An initial 12-week placebo-controlled part focused on PTC518 pharmacology and pharmacodynamic effect.
Followed by a 9-month placebo-controlled part, during which blood (CSF) and radiographic biomarker data will be collected.
The study will initially include two dose levels, 5 milligrams, and 10 milligrams, with the potential to study a third dose leveraging the titratability of the drug.
The approvals received for the 12-month study include both the 5mg and 10mg dose levels and a potential third dose pending the results of the first two dosing cohorts.
Enrollment in the 12-week portion of the study began first in the U.S. and continues globally.
To date, no treatment-related adverse events have been reported in the U.S. or outside of the U.S.
However, the FDA has requested additional data to allow the study to proceed in the U.S. Accordingly, enrollment in the U.S. has been paused while discussions with the FDA continue.
PTC is working towards sharing data from the 12-week portion of PIVOT-HD within the first half of 2023.
Price Action: PTCT shares closed 15.7% lower at $41.11 during after-hours trading on Tuesday.
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