Lipocine Inc. (NASDAQ: LPCN) jumped 4.5% after the company announced that the FDA had cleared its Investigational New Drug Application for commencement of a Phase 2 trial evaluating LPCN 1154’s therapeutic potential. LPCN 1154 is an oral neurosteroid for postpartum depression (PPD) treatment in adults.
LPCN 1154 PK study to commence in July
A pharmacokinetic (“PK”) study to determine dose proportionality will begin in July 2021. The company will report top-line results in the third quarter. A proof-of-concept trial to examine LPCN 1154’s tolerability, safety, and efficacy in adult female participants diagnosed with PPD is expected to begin in the fourth quarter of 2021, after the PK study.
PPD is an underdiagnosed severe depressive disease that affects about one in every seven women in the US after giving birth. The disorder can have severe effects on the mother, her baby, and her household. Presently there is no approved oral medication for PDD treatment. LPCN 1154 is a potential therapy, and it contains an endogenous positive allosteric modulator of the -aminobutyric acid (“GABAA”) receptor. Once approved, LPCN 1154 will provide “at home” treatment with easier access to treatment than the current standard of care invasive alternative, which needs hospitalization and has significant limits. Furthermore, LPCN 1154 will afford the mother the needed level of privacy, minimizing breastfeeding/bonding interruptions caused by the current treatment option.
Lipocine to commence neuroendocrinology study
Dr. Mahesh Patel, Lipocine CEO and President said they are excited to use their unique oral-enabling technology platform to commence a neuroendocrinology study for a significant neuropsychiatric indication with a significant unmet need. He added that they are optimistic LPCN 1154 has the potential to be a good PPD therapeutic option.
Besides LPCN 1154, ORLANDO, the company’s proprietary oral testosterone prodrug, has tentative FDA approval for hypogonadism.