Slide 1: LPCN 1144 for Non-Cirrhotic NASH Open Label Extension (OLE) Study – Topline Results
LPCN 1144 for Non-Cirrhotic NASH Open Label Extension (OLE) Study – Topline Results May 2022
Slide 2: LPCN 1144: NASH Open Label Extension Study Objective & Design
LPCN 1144: NASH Open Label Extension Study Objective & Design Objective: To evaluate the safety and tolerability of extended (up to 72 weeks) treatment with LPCN 1144 in subjects with biopsy confirmed Nonalcoholic Steatohepatitis (NASH) ❑ A multicenter study (NCT04685993) to provide LPCN 1144 treatm
Slide 3: Disposition and Analysis Sets
LPCN 1144: NASH Open Label Extension Study Disposition and Analysis Sets ❑ Biopsy confirmed male NASH subjects (N=25, OLE-SS, OLE-Safety Set) who completed LiFT study ❑ Extended LPCN 1144 treatment subjects (n=16): Total of 72-weeks of LPCN 1144 treatment • 36 weeks of LPCN 1144 treatment in LiFT +
Slide 4: Safety Overview of LPCN 1144 in OLE
Safety Overview of LPCN 1144 in OLE Well-Tolerated with No Observed Safety Signals ❑ In the OLE-SS, the frequency and severity of TEAEs were comparable to those observed in the LiFT study ❑ There were no reported cases of cardiovascular events, thromboembolic events, hepatocellular carcinoma, or dru
Slide 5: Observed Key Liver Injury Markers Change from Baseline
Observed Key Liver Injury Markers Change from Baseline Liver Injury Markers were Reduced Significantly and Maintained with Extended LPCN 1144 Treatment Week 36 Week 72 Week 36 Week 72 20 5 ALT CBL (U/L) AST CBL (U/L) 10 BL: 61.8 U/L BL: 65.9 U/L BL: 38.4 U/L BL: 37.4 U/L 0 0 -10 -5 -20 -30 -10 -25.4
Slide 6: Histological Changes in OLE Subjects with EOS Biopsy: Extended LPCN 1144 Subjects
Histological Changes* in OLE Subjects with EOS Biopsy Extended LPCN 1144 treatment subjects Baseline Week 36 Week 72 NASH Resolution with No Worsening of Fibrosis LPCN 1144 LPCN 1144 Fibrosis Improvement with No Worsening of NASH LPCN 1144 LPCN 1144 Phase 2 – LiFT Phase 2 - OLE Black = Improved indi
Slide 7: Histological Changes in OLE Subjects with EOS Biopsy: Subjects Initiated after Placebo Run-In
Histological Changes* in OLE Subjects with EOS Biopsy Subjects Initiated LPCN 1144 Treatment after Placebo Run-In Baseline Week 36 NASH Resolution with No Worsening of Fibrosis Placebo LPCN 1144 36 weeks Fibrosis Improvement with No Worsening of NASH Placebo LPCN 1144 36 weeks Phase 2 – LiFT Phase 2
Slide 8: Summary
Summary Positive LPCN 1144 NASH Open Label Extension Study Results Well tolerated over 72-week Liver injury markers were Observed liver histology exposure with no observed reduced significantly and improvements support safety signals maintained with extended further development treatment OLE Results