Pinteon Therapeutics Announces Promising Phase 1 Data for Novel Tau Antibody PNT001
Study showed PNT001 was well-tolerated at dose levels that may provide potential therapeutic effect
PNT001 to be evaluated next in patients with traumatic brain injury
CAMBRIDGE, Mass. – Feb. 1, 2021 – Pinteon Therapeutics, a biotechnology company focused on protecting neuronal health by targeting neurotoxic forms of tau, today announced results from its Phase 1 study of PNT001, a novel tau antibody that uniquely targets a toxic epitope known to drive neurodegenerative disease. The results showed PNT001 was well-tolerated in healthy volunteers at doses that lead to a potentially therapeutic drug concentration in the cerebrospinal fluid (CSF). These doses will be evaluated next in multiple ascending dose studies in patients with traumatic brain injury and other tauopathies.
“Traumatic brain injury and other tauopathies can have devastating effects on cognitive function and quality of life, yet there are currently no therapies that can halt or slow the rate of decline in these patients,” said Martin Jefson, Ph.D., Pinteon’s chief executive officer. “We are pleased by the encouraging results from our first Phase 1 study, which give us a strong foundation to advance PNT001 into patient populations as we work to develop a treatment that can reduce the acute, neurotoxic effects of cis-pT231 tau, as well as stop the spread of pathologic tau and preserve function in patients living with tauopathies.”
PNT001 is a monoclonal antibody targeting an epitope on a highly neurotoxic conformation of the tau protein called cis-pT231 tau. This conformation of tau is acutely neurotoxic and also contributes to the initiation and spread of tau pathology in neurodegenerative tauopathies, such as traumatic brain injury, chronic traumatic encephalopathy, Alzheimer’s disease and progressive supranuclear palsy.
The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers. The study included 49 participants across six dose cohorts (up to 4,000 mg). Participants were randomized to receive a single dose of PNT001 or placebo, and were followed for 16 weeks. Three non-serious Grade 1 adverse events were determined to be related to PNT001 or placebo, and all resolved without sequelae. No maximum tolerated dose was identified, and there were no premature discontinuations, dose reductions or dose interruptions due to treatment-related adverse events. Well-tolerated doses produced CSF concentrations of PNT001 that suggest a potentially therapeutic effect. More information about the study can be found on ClinicalTrials.gov (NCT04096287).
About Pinteon Therapeutics
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. Pinteon is led by an experienced management team with strong track records in CNS drug discovery and development and is funded by Morningside Ventures. For more information, visit pinteon.com.
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