PTC Provides Update on Ongoing Global PIVOT-HD Trial For PTC518
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.
Enrollment in the 12-week portion of the study began first in
PTC is working towards sharing data from the 12-week portion of PIVOT-HD within the first half of 2023.
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC's mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC's strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients. PTC believes this allows it to maximize value for all its stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Instagram, Facebook, Twitter, and LinkedIn.
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This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this release, other than statements of historic fact, are forward-looking statements, including statements regarding: the future enrollment, study design, expected timing, availability of data, regulatory submissions and responses and other matters related to PTC's Phase 2 trial of PTC518 for the treatment of Huntington's disease; PTC's strategy, future operations, future financial position, future revenues, projected costs; and the objectives of management. Other forward-looking statements may be identified by the words, "guidance", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
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