Lipocine has announced the commencement of a randomised Phase III clinical trial of LPCN 1154, an oral formulation of brexanolone, being developed for treating postpartum depression (PPD).
The trial’s initiation follows comparative exposure between LPCN 1154 and the reference drug from a pharmacokinetic bridge trial.
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Lipocine anticipates the first subject to be dosed in the second quarter of this year in the Phase III study.
The blinded, placebo-controlled outpatient trial aims to assess the efficacy and safety of the therapy in women with PPD.
This study is designed to support a global registration package for LPCN 1154 in treating PPD. It will compare the therapy against a placebo in women aged 15 years and above who are diagnosed with severe PPD, with a treatment regimen of a 48-hour dosing period.
Change from baseline in the Hamilton Depression Rating Scale (HAM-D) is the primary endpoint.
Secondary endpoints include changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Rating Scale (HAM-A), alongside main tolerability and safety measures.
The size of the trial is determined depending on the impact of the treatment observed with the injectable brexanolone.
Lipocine CEO Mahesh Patel said: “We are excited to initiate this registration-enabling Phase III trial.
“Importantly, based on Food and Drug Administration (FDA) protocol feedback, patients will self-administer LPCN 1154 at home. We believe that LPCN 1154 has the potential to be the first line option for rapid symptom relief in women with PPD.”
Brexanolone, is stated to be “bioidentical” to naturally occurring neuroactive steroid allopregnanolone.
Lipocine’s clinical development pipeline includes several candidates targeting various conditions.
In addition to LPCN 1154, the company is developing LPCN 2203 for essential tremor management, LPCN 2101 for epilepsy.
It is seeking collaboration opportunities for LPCN 1107, LPCN 2401, LPCN 1148, and LPCN 1144, which address preterm birth prevention, obesity management, decompensated cirrhosis, and metabolic dysfunction-associated steatohepatitis (MASH), respectively.
