The Phase I study has been designed for evaluating the CNS pharmacokinetics and pharmacodynamics of LP352 in healthy participants. Credit: Josh Riemer on Unsplash.

Longboard Pharmaceuticals has reported positive data from a Phase I clinical study of the oral, centrally acting 5-HT2C superagonist, LP352.

The open-label Phase I study has been designed for evaluating the central nervous system (CNS) pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered LP352 in healthy participants.

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The trial’s objectives include the characterisation of safety and tolerability of doses with titration and taper, and the characterisation of plasma and cerebrospinal fluid (CSF) PK.

It also includes evaluation of the PK-PD relationships between plasma and CSF exposure, and PD safety and efficacy endpoints.

Findings from the study showed that LP352 exhibited a strong correlation between plasma and CSF PK concentration that increased in a consistent and dose-dependent manner.

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Early quantitative electroencephalogram (qEEG) changes, as well as sustained effects on qEEG activity following continuous dosing in a dose-dependent manner, were observed in the trial.

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The company stated that favourable safety and tolerability results were observed, with adverse events (AEs) generally consistent with earlier LP352 clinical studies.

Longboard chief medical officer Dr Randall Kaye said: “We are excited to share data from our 102 study, the first known of its kind for a 5-HT2 receptor agonist, to further elucidate the potentially best-in-class profile of LP352.

“We believe the results of this study are encouraging as orally administered LP352 plasma and CSF PK concentration increased in a dose-dependent and consistent manner, a clear indicator that LP352 is crossing the blood brain barrier.

“Furthermore, the observation of demonstrated effects on qEEG activity within the first few doses and after continuous dosing suggests that LP352 engaged neurotransmitter systems and altered the EEG spectrum.”