Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, today announced that it has filed an Investigational New Drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”) to initiate a Phase 2 clinical study of LPCN 1144 in non-alcoholic steatohepatitis (“NASH”) with biopsy confirmed NASH subjects.
“This IND filing is an important step forward as we pursue further evaluation of LPCN 1144 in biopsy confirmed NASH patients for the treatment of NASH. There is currently no FDA approved product for the treatment of NASH and we believe our well-tolerated oral LPCN 1144 is well positioned to mechanistically address this disease and provide additional unmet benefits,” said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.
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