Lipocine Announces First Patient Dosed In Phase 1 Study In Pregnant Women Of LPCN 1107, Potentially The First Oral Product For The Prevention Of Preterm Birth

Lipocine Inc.

, a specialty pharmaceutical company, today announced the first patient was dosed in a Phase 1 study in pregnant women of LPCN 1107, the company's oral hydroxyprogesterone caproate (HPC) product candidate. The primary objectives of the study will be to determine safety, tolerability and pharmacokinetics of oral administration of LPCN 1107 in pregnant subjects. "Based on previous clinical testing, we believe that LPCN 1107 has the potential to become the first oral product for prevention of preterm birth. HPC is the only drug approved for prevention of recurrent preterm birth, a leading cause of peri-natal mortality and morbidity worldwide, but it is currently only available in an inconvenient injectable form that may cause pain at the site of injection and requires several visits to the physician during the course of treatment," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look forward to presenting top-line results from this study in 2015." This Phase 1, open-label study will enroll up to eight healthy, pregnant female subjects of child bearing age with a normal pregnancy of 16 to 18 weeks. In period one, subjects will receive two doses of 400 mg oral LPCN 1107, administered 12 hours apart. In period two, subjects will receive two doses of 800 mg oral LPCN 1107, administered 12 hours apart. In period three, subjects will be given 250 mg of HPC via intramuscular injection. There will be a washout period of at least three days between each period. Blood samples will be taken and used to determine the pharmacokinetics for each period. Previously in Phase 1 clinical testing, LPCN 1107 was well tolerated and achieved meaningful drug levels after oral administration in healthy, non-pregnant women.