Lipocine to Present Preclinical Data on Therapeutic Potential of LPCN 1144 in Hepatic Fibrosis and NASH at The Liver Meeting Digital Experience™
SALT LAKE CITY, Nov. 5, 2020 /PRNewswire/ -- Lipocine Inc.(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced it will present a poster with results from a preclinical study investigating LPCN 1144 treatment on hepatic fibrosis and non-alcoholic steatohepatitis ("NASH") features at The Liver Meeting Digital Experience™, hosted by the American Association for the Study of Liver Diseases ("AASLD"). The poster will be available virtually on Friday, November 13, 2020, Room 1970 between 6:00 AM - 11:55 PM ET.
"It has been shown that low testosterone levels in men are independently associated with the presence and severity of NASH," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine Inc. Dr. Patel further stated, "These preclinical data add to our understanding of the effects of oral testosterone on the liver, showing that LPCN 1144 improved high fat diet induced hepatic fibrosis and NASH features."
Lipocine recently announced completion of enrollment in its LiFT ("Liver Fat intervention with oral Testosterone") Phase 2 clinical study, a paired-biopsy study investigating LPCN 1144 in confirmed NASH subjects. The Company expects to report top-line change in liver fat data measured by MRI-PDFF (primary endpoint) in January 2021. Subsequently, 36-week biopsy and MRI-PDFF data are expected mid-2021. For more information, refer to NCT04134091.
LPCN 1144 Treatment Potential Assessment in a High Fat Diet Induced Rabbit Model of Hepatic Fibrosis and NASH (Kilyoung Kim et al)
The goal of this study was to evaluate the treatment potential of daily LPCN 1144 on histological and biochemical features of NASH and fibrosis using a high fat diet ("HFD")-induced NASH model. Male rabbits were randomly assigned to 5 groups: regular diet ("RD"), HFD, HFD+LPCN 1144 vehicle ("VEH"), HFD+LPCN 1144, and HFD+LPCN 1144+a-tocopherol ("LPCN 1144+AT). The study duration was 12 weeks.
Both the LPCN 1144 and LPCN 1144+AT arms improved mean histological scores of NASH with fibrosis compared to HFD arm. Importantly, the fibrosis percentage (in sampled liver tissue area) was significantly improved in both the LPCN 1144 (p<0.05) and LPCN 1144+AT (p=0.05) treatment arms vs the HFD arm. Both LPCN 1144 and LPCN 1144+AT arms also reduced HFD-induced elevated liver mRNA inflammation and fibrosis markers. Furthermore, LPCN 1144 concomitant treatment improved insulin resistance, visceral adiposity, and low testosterone (metabolic dysfunctions) induced by HFD.
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SOURCE Lipocine Inc.
Company Codes: NASDAQ-SMALL:LPCN