(RTTNews) - PTC Therapeutics Inc. (PTCT), in an update on ongoing its phase 2 PIVOT-HD trial of PTC518 for the treatment of Huntington's disease, said that the U.S. Food and Drug Administration requested additional data to allow the study to proceed in the US. Accordingly, enrollment in the US has been paused while discussions with the FDA continue towards resuming US enrollment.
PTCT closed Tuesday regular trading at $48.78 down $6.01 or 10.97%. In the after-hours trade, the stock further dropped $7.67 or 15.72%.
To date, PTC has received approval for conduct of the planned 12-month study in several European countries as well as Australia.
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 to date for the 12-month study include both the 5mg and 10mg dose levels, as well as a potential third dose pending the results of the first two dosing cohorts.
PTC noted that it is working towards sharing data from the 12-week portion of PIVOT-HD within the first half of 2023.
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