PNT001 will be assessed in multiple ascending dose studies in patients with traumatic brain injury. Credit: Robina Weermeijer on Unsplash.

Biotechnology company Pinteon Therapeutics has announced results from its Phase I study of novel tau antibody, PNT001, in treating neurodegenerative tauopathies.

The monoclonal antibody targets a neurotoxic epitope, cis-pT231 tau.

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PNT001 is the lead asset of Pinteon and is the only antibody being developed to target cis-pT231 tau.

The Phase I study assessed the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers.

It enrolled 49 subjects across six dose cohorts (up to 4,000mg) and were randomly given a single dose of PNT001 or placebo. They were followed up for 16 weeks.

According to the data, PNT001 was demonstrated to be well-tolerated in healthy volunteers at doses that suggest a potential therapeutic drug concentration in the cerebrospinal fluid (CSF).

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In addition, no maximum tolerated dose was detected and no premature discontinuations, dose reductions or dose interruptions due to treatment-related adverse events were observed in the trial.

The company noted that these doses will be analysed in multiple ascending dose studies in patients with traumatic brain injury, as well as other tauopathies.

Pinteon Therapeutics CEO Martin Jefson said: “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.

“We are pleased by the encouraging results from our first Phase I 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.”