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PTC Therapeutics Pauses Enrollment In Huntington's Candidate Trial In US

Published 19/10/2022, 11:28
© Reuters. PTC Therapeutics Pauses Enrollment In Huntington's Candidate Trial In US
PTC
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PTCT
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  • PTC Therapeutics Inc (NASDAQ: 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.
© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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