Lipocine doses first patient in Phase 3 study for oral testosterone replacement therapy

SALT LAKE CITY—Lipocine Inc., a specialty pharmaceutical company, today announced that the first patient has been dosed in its Study of Oral Androgen Replacement (SOAR) Phase 3 clinical study. The trial is designed to evaluate the safety and efficacy of LPCN 1021, an oral testosterone replacement therapy, in hypogonadal men with low testosterone. Approximately 300 patients are expected to be enrolled in multiple sites in the United States. The company expects to report top-line efficacy data for the trial in the second half of 2014 with a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) anticipated in the second half of 2015.

"LPCN 1021 represents a differentiated testosterone replacement therapy approach to treating hypogonadism in men that has the potential to improve patient compliance and overcome inadvertent testosterone transference risk of secondary exposure to women and children associated with topicals," said Dr. Mahesh Patel, president and CEO of Lipocine Inc. "The commencement of the Phase 3 trial is an important milestone for both LPCN 1021 and the company as we move into late-stage testing for our lead product. We are pleased with the high degree of interest in this study shown by both investigators and patients," Patel added.

SOAR is a randomized, open-label, parallel-group, Phase 3 clinical study of hypogonadal males with low testosterone. All subjects will be randomized in 2:1 ratio, such that approximately 200 will be treated with LPCN 1021 for 52 weeks and 100 with Androgel 1.62 percent (the best selling gel product) for 52 weeks.

The co-primary endpoints of the study will be the percentage of subjects achieving 24-hour average total serum testosterone concentration (Cavg(0-24)) within the normal range of 300 to 1140 ng/dL after completion of 13 weeks of treatment, Secondary endpoints of the study are based on the maximum serum total testosterone concentration (Cmax) after completion of 13 weeks of treatment and will include:  percentage of subjects who have a Cmax below 1500 ng/dL;  percentage of subjects with Cmax between 1,800 and 2,500 ng/dL; and percentage of subjects with Cmax above 2,500 ng/dL. Safety of LPCN 1021 will be monitored over the 52 weeks of treatment.

Previously, Lipocine completed a successful Phase 2 study for LPCN 1021 that produced results consistent with FDA guidelines for approval of testosterone replacement therapies for the starting dose selected for the SOAR trial. The primary and secondary outcomes of the trial were met and there were no significant adverse events.

The current testosterone market is dominated by topical products that are associated with poor patient compliance and FDA black-box warnings related to inadvertent transfer of testosterone. LPCN 1021 is a twice-a-day, oral product with low gastrointestinal drug exposure that is expected to overcome the major shortcomings of existing products with a more patient/ physician friendly label that includes three simple dosing options and faster time to maintenance dose in most patients. Unlike a selective estrogen receptor modulator (SERM), LPCN 1021 is not designed to interact with estrogen receptors and is targeted to address an unmet oral option needed in the established testosterone replacement market for chronic use.

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men's and women's health using proprietary drug delivery technologies. LPCN 1021 is Phase 3 ready to treat symptoms of low testosterone for men in need of testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of preterm birth.