Policy & Regulation
First Patient Dosed in Phase 1 Study of PNT001 in Patients with Acute Traumatic Brain Injury
6 April 2021 - - The first patient has been dosed in a Phase 1b multiple ascending dose study evaluating PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease, in patients with acute traumatic brain injury, US-based biotechnology company Pinteon Therapeutics said.

The randomized, double-blind, placebo-controlled multiple ascending dose study will enroll 64 patients across two dose level cohorts that, based on the Phase 1 study in healthy volunteers, will provide potentially therapeutic cerebrospinal fluid concentrations of PNT001.

Patients will be randomized to receive three monthly intravenous doses of PNT001 or placebo, and will receive their first dose within 24 hours of documented traumatic brain injury. Safety, tolerability, pharmacokinetic, biomarker, imaging and cognitive data will be collected over 12 weeks.

More information about the study can be found on ClinicalTrials.gov (NCT04677829).

Pinteon Therapeutics is advancing clinical studies of a novel antibody that aims to interrupt the spread of toxic tau and protect and preserve brain function in patients with neurodegenerative disease.

Pinteon's lead asset, PNT001, is the only antibody in development that targets cis-pT231 tau, a neurotoxic epitope that has been identified in multiple preclinical studies as a potent driver of neurodegenerative disease.

The company reported promising Phase 1 safety data early in 2021 showing PNT001 was well-tolerated at dose levels that may provide potential therapeutic effect.

Pinteon is led by an experienced management team with strong track records in CNS drug discovery and development and is funded by Morningside Ventures.


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