Lipocine, Inc. (NASDAQ:LPCN) shares are trading lower Thursday after the company reported topline safety and efficacy results for LPCN 1154 in patients with postpartum depression.
- Lipocine stock is testing key support levels. Why are LPCN shares at support?
Phase 3 Trial Misses Primary Endpoint
Lipocine said LPCN 1154 did not show a statistically significant reduction from baseline in HAM-D17 total score compared to placebo at hour 60 in the overall study population, and the primary endpoint was not met.
The HAM-D17 is a clinical scale used to measure depression severity, with score reductions indicating symptom improvement.
In a post hoc analysis of participants with a history of psychiatric conditions, LPCN 1154 demonstrated nominally statistically significant and clinically meaningful reductions in HAM-D scores compared to placebo as early as hour 12, with effects sustained through day 30.
The company said the treatment was well tolerated across the overall population, with no treatment-related serious adverse events reported and no adverse events occurring in more than 5% of treated participants.
Lipocine added that LPCN 1154 demonstrated a favorable safety profile that may support outpatient administration without the need for healthcare provider monitoring.
The company said it has applied for breakthrough therapy and Fast Track designations for LPCN 1154 in postpartum depression and plans to evaluate all available options moving forward.
Lipocine Shares Fall
LPCN Price Action: At the time of publication, Lipocine shares are trading 78.27% lower at $2.01, according to data from Benzinga Pro.
This illustration was generated using artificial intelligence via Midjourney.
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