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Lipocine Says FDA Clears IND Application To Initiate Phase 2 Study For LPCN 1154 - Quick Facts

Biopharmaceutical company Lipocine Inc. (LPCN) announced Tuesday that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) to initiate a Phase 2 study to evaluate the therapeutic potential of LPCN 1154, an oral neuro-steroid product candidate, for the treatment of postpartum depression (PPD) in adults.

A pharmacokinetic (PK) study to assess dose proportionality is planned to start in July 2021 with top-line results expected in the third quarter of 2021. Following the PK study, a proof-of-concept study to evaluate the safety, tolerability, and efficacy of LPCN 1154 in adult female subjects diagnosed with PPD is expected to occur with the first subject dosed in the fourth quarter of 2021.

PPD, a major depressive disorder that is under diagnosed in US, impacts approximately 1 in 7 women after giving birth. PPD can lead to devastating consequences for a woman, her newborn and her family. Currently, there is no oral therapy approved for the treatment of PPD.

The active moiety in LPCN 1154 is an endogenous positive allosteric modulator of ?-aminobutyric acid (GABAA) receptor. LPCN 1154 is expected to be an "at home" treatment with easier treatment access than the current standard of care invasive option that requires hospitalization with significant limitations.

Moreover, LPCN 1154 is expected to provide the required level of privacy for a mother, avoiding bonding/breast feeding interruptions due to the required hospitalizations for the current option.

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