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NASH Open Label Extension Study Results
On May 12, 2022 Lipocine (NASDAQ:LPCN) announced results from its NASH Open Label Extension (OLE) study. Safety was confirmed with no observed safety signals over the 72-week duration of exposure and liver injury markers were either maintained or reduced with the use of LPCN 1144. The data was sufficiently compelling to support further development in a pivotal trial. The OLE study was an extension of the 36 week Phase II LiFT study which produced topline results in August 2021 and was summarized in our report update here. Next steps are to hold an End of Phase II meeting with the FDA to identify trial design which will further determine Lipocine's next strategic step forward.
Of the 25 subjects enrolled in the OLE safety set, 16 participants were in the LPCN 1144 arm of the LiFT study and the remainder were assigned to the placebo arm. 23 completed the OLE with two discontinuations due to a non-drug related treatment emergent adverse event (TEAE). The purpose of the extension was to evaluate safety and tolerability of LPCN 1144 and monitor subject health over the observation period. Adverse events that were observed, including a gastrointestinal (GI) event and pedal edema, were not considered related to the study drug. Furthermore, no clinically meaningful changes in lipids were observed. This is an important conclusion as many of the investigational drugs in development for non-alcoholic steatohepatitis (NASH) were associated with poorly-tolerated adverse effects.
Six subjects chose to undergo an optional liver biopsy at the end of the OLE to provide additional safety data. Three of the enrollees were on treatment for the full 72 weeks of treatment. In this group, NASH resolution with no worsening fibrosis and fibrosis improvement with no worsening of NASH was observed as detailed below.
Three patients that started out in the placebo group for the LiFT portion of 36 weeks also received a biopsy to assess their status. Multiple individuals in this group also saw either an improvement in NASH resolution with no worsening fibrosis or fibrosis improvement with no worsening of NASH during the LPCN 1144 treatment period during the last 36 weeks of observation. Details of patients in each category are below.
TEAEs for the OLE were comparable to what was observed in the LiFT study with no reported cases of cardiovascular events, thromboembolic events, hepatocellular carcinoma or drug induced liver injury. Liver injury in particular was significantly reduced during the OLE compared to baseline. Liver data is summarized below.
Overall, the data was supportive of further development of LPCN 1144 in male patients with NASH. This has been a space with many dashed hopes as a number of candidates from other sponsors failed to generate strong enough data to merit a submission to the FDA due to either lack of efficacy or negative side effects. With the favorable safety data in hand, Lipocine's next step is to hold an End of Phase II meeting with the FDA to nail down trial design which will guide next steps forward.
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1. Source: LPCN Oral Neurosteroids Presentation, March 2022
2. Source: LPCN Oral Neurosteroids Presentation, March 2022. Black = Improved individual subject; Red = Individual subject without improvement. Baseline was measured prior to LPCN 1144 treatment initiation. Biopsy changes in the subjects assessed utilizing NASH CRN (Clinical Research Network) scori
3. Source: LPCN Oral Neurosteroids Presentation, March 2022. Black = Improved individual subject; Red = Individual subject without improvement. Baseline was measured prior to LPCN 1144 treatment initiation. Biopsy changes in the subjects assessed utilizing NASH CRN (Clinical Research Network) scori
4. Source: LPCN Oral Neurosteroids Presentation, March 2022
