Press Release (ePRNews.com) - WINSTON-SALEM, N.C. - Jun 20, 2017 - Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies.
Lipocine’s clinical development pipeline includes three development programs LPCN 1021, LPCN 1111 and LPCN 1107.
LPCN 1021, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men. LPCN 1021 was well tolerated and met the primary efficacy end-points in Phase 3 testing with twice daily dosing.
LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing and is currently in Phase 2 testing.
LPCN 1107, the potentially first oral hydroxyprogesterone caproate product candidate indicated for the prevention of recurrent preterm birth, has been granted orphan drug designation by the FDA. An End of Phase 2 meeting with the FDA has been completed.
LPCN Investor Highlights
• Product Development – LPCN 1021 achieved primary endpoints confirming the efficacy of twice daily oral administration.
• Innovation – New Drug Application resubmission planned in the third quarter of 2017.
• Progress: On April 24th Lipocine announced it had completed enrollment of the LPCN 1021 fixed dose trials.
• Upcoming Milestones – Topline results from DV and DF studies for LPCN 1021 expected in June 2017.
• Submission of LPCN 1107 Phase III protocol anticipated in 2Q:17.
LPCN 1021 is an oral testosterone replacement therapy product candidate containing Testosterone Undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. Lipocine expects LPCN 1021 will help fulfill an unmet need in the treatment of hypogonadism. The current testosterone market primarily uses short-acting injectable products as well as topical products that carry an FDA “black box” warning related to inadvertent transfer of testosterone to others. Per the IMS Health database, an average of 540,000 prescriptions a month have been dispensed from January 2016 through December 2016 for testosterone products.
LPCN 1111 is a novel ester prodrug of testosterone which uses the Lip’ral technology to enhance solubility and improve systemic absorption. A Phase 1 single dose randomized, open label, crossover study in postmenopausal women has been completed and the pharmacokinetics suggested feasibility of once-daily dosing. Further, a Phase 2a study established once-daily dosing potential in hypogonadal men.
LPCN 1107 is an oral product candidate of 17-alpha hydroxyprogesterone caproate under development for the indication of prevention of recurrent preterm birth. LPCN 1107 has the potential to become the first oral HPC product for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal, family or professional activities associated with weekly visits.
To learn more about LPCN visit http://www.smallcapreview.com/lpcn.htm.
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