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$Lipocine (LPCN.US)$ Lipocine Announces Positive Oral Brexanolone Quantitative EEG Results
● Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation
● Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone
● Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders
SALT LAKE CITY, Oct. 10, 2024 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression (PPD). Changes in spectral power (a quantitative measure of the strength or intensity of specific brain wave frequencies) are frequently used to characterize the effects of drug candidates and may have utility in indication and dose selection in CNS clinical trials. The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications.
“We are pleased with the qEEG results that confirm target engagement of oral bioidentical brexanolone, which suggests potential utility in treating numerous psychiatry indications, including depression and anxiety, and neurology indications such as essential tremor and epilepsy,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “These positive biomarker results and favorable safety profile support further development of oral brexanolone.”
This Phase 1 study evaluated qEEG spectral power changes after administration of oral brexanolone. Healthy postmenopausal females (N=12) were administered single doses of oral brexanolone. EEG recordings and blood samples were collected pre- and post-dose (2, 4 and 12 hours). EEG recordings were obtained using a wireless, 19-electrode EEG monitoring device (Zeto Inc., Santa Clara, CA). Spectral analysis was performed and EEG band amplitudes were analyzed for the oscillatory spectra. Pre-dose-adjusted spectral power values at each single-electrode location were determined for each post-dose timepoint.
Following a single clinically relevant dose of oral brexanolone, subjects showed mean changes in all oscillatory spectral power bands. As shown in Fig. 1, theta and alpha1 band power were significantly increased in posterior cortical regions, while alpha2 band power decreased. There was considerable beta band amplitude increase, including significant increase in beta2 amplitude across all cortical brain areas Most of the treatment-related EEG changes were rapid occurring as early as 2 hours, with maximum and significant mean contrast values at 4 hours post dose (consistent with Tmax) with appreciable effects lasting 12 hours post-dose.
● Quantitative Electroencephalogram (qEEG) in healthy subjects administered single doses of oral brexanolone, a neuroactive steroid (NAS), confirmed GABAA modulation
● Rapid and durable CNS target engagement confirms effective oral delivery of bioidentical brexanolone
● Promising results support continued development of oral brexanolone for the treatment of neuropsychiatric disorders
SALT LAKE CITY, Oct. 10, 2024 — Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced positive data from its qEEG study of its oral brexanolone, a proprietary bioidentical NAS being developed for the treatment of post-partum depression (PPD). Changes in spectral power (a quantitative measure of the strength or intensity of specific brain wave frequencies) are frequently used to characterize the effects of drug candidates and may have utility in indication and dose selection in CNS clinical trials. The results indicate robust central nervous system (CNS) activity of oral brexanolone, with concentration- and time-dependent post-dose changes in qEEG. These results confirm GABAA positive allosteric modulation and support future development of oral brexanolone in neuropsychiatric indications.
“We are pleased with the qEEG results that confirm target engagement of oral bioidentical brexanolone, which suggests potential utility in treating numerous psychiatry indications, including depression and anxiety, and neurology indications such as essential tremor and epilepsy,” said Dr. Mahesh Patel, President and CEO of Lipocine Inc. “These positive biomarker results and favorable safety profile support further development of oral brexanolone.”
This Phase 1 study evaluated qEEG spectral power changes after administration of oral brexanolone. Healthy postmenopausal females (N=12) were administered single doses of oral brexanolone. EEG recordings and blood samples were collected pre- and post-dose (2, 4 and 12 hours). EEG recordings were obtained using a wireless, 19-electrode EEG monitoring device (Zeto Inc., Santa Clara, CA). Spectral analysis was performed and EEG band amplitudes were analyzed for the oscillatory spectra. Pre-dose-adjusted spectral power values at each single-electrode location were determined for each post-dose timepoint.
Following a single clinically relevant dose of oral brexanolone, subjects showed mean changes in all oscillatory spectral power bands. As shown in Fig. 1, theta and alpha1 band power were significantly increased in posterior cortical regions, while alpha2 band power decreased. There was considerable beta band amplitude increase, including significant increase in beta2 amplitude across all cortical brain areas Most of the treatment-related EEG changes were rapid occurring as early as 2 hours, with maximum and significant mean contrast values at 4 hours post dose (consistent with Tmax) with appreciable effects lasting 12 hours post-dose.
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