Lipocine says LPCN 1021 achieved primary endpoints in dosing studies
Lipocine announced results from both the Dosing Validation and the Dosing Flexibility studies evaluating efficacy and tolerability of LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The results from these studies confirm the validity of a fixed dose approach without the need for dose titration to orally administering LPCN 1021. LPCN 1021 successfully met the FDA primary efficacy guidelines in the DV study where 81% of the subjects achieved average testosterone levels within the normal range with a lower bound confidence interval of 72%. The DF study restored 70% of the subjects' average testosterone levels within the normal range confirming that twice daily dosing is the appropriate dosing regimen for LPCN 1021 and will be the basis for resubmission. The adverse event profile of LPCN 1021 in both the DV and DF studies was consistent with the previously conducted 52-week Phase 3 Study of Androgen Replacement clinical trial. All drug related adverse events were either mild or moderate in intensity and none were severe, the company said. "We are pleased with the confirmation of LPCN 1021 efficacy, especially with a more practical patient and physician preferred "no titration" dosing regimen. We believe the results should address the label-related deficiency cited by the FDA in our NDA submission. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men with the potential to both improve patient compliance and eliminate the risk of testosterone transference. We look forward to resubmitting the NDA in the third quarter of 2017," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.