FDA Clears LPCN 1148 IND Application for Phase 2 Cirrhosis Trial

Lipocine announced that the U.S. Food & Drug Administration (FDA) has accepted the Company's Investigational New Drug application (IND) to initiate a Phase 2 proof-of-concept study to evaluate the therapeutic potential of LPCN 1148, an oral prodrug of bioidentical testosterone, for the treatment of liver cirrhosis in adult male cirrhotic patients. The planned Phase 2 clinical study is a prospective, multi-center, randomized, placebo-controlled 52-week study in male cirrhotic patients that are on the liver transplant list. Contingent upon available funding, Lipocine projects study initiation in the fourth quarter of 2020 or the first quarter of 2021.

Liver cirrhosis is estimated to affect in excess of 600,000 Americans, with men affected at twice the rate of women, and results in approximately 45,000 deaths every year. Due to a lack of available organs, only a third of waitlisted patients receive liver transplants, and patients who do receive a transplant are increasingly being described as frail. Low testosterone affects up to 90% of cirrhotic men, and is a predictor of mortality and increased adverse events including ascites, hepatic encephalopathy, and clinically significant portal hypertension.

"We are excited the FDA has accepted the LPCN 1148 Phase 2 clinical protocol to test our potential treatment in cirrhotic patients," said Dr. Mahesh Patel, Chairman, President, and Chief Executive Officer of Lipocine. "We believe LPCN 1148 has the potential to improve survivability and quality of life for cirrhotic patients."

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