Slide 1: A 24-Week (12-Week Extension) Trial of Pemvidutide in Subjects with NAFLD
A 24 - Week (12 - Week Extension) Trial of Pemvidutide in Subjects with Non - alcoholic Fatty Liver Disease (NAFLD) NASDAQ: ALT Stephen Harrison, MD, Lead Investigator 20 December 2022
Slide 2: Forward-looking statements
Forward - looking statements Safe - Harbor Statement This presentation has been prepared by Altimmune, Inc .. ("we," "us," "our," "Altimmune" or the "Company") and includes certain “forward - looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 , including s
Slide 3: Pemvidutide NAFLD Extension Trial Design
Pemvidutide NAFLD Extension Trial Design • 83 subjects who completed the 12 - week Phase 1b NAFLD trial were invited to participate, to receive a total of 24 weeks of treatment • 12 - week extension trial of pemvidutide in subjects with non - alcoholic fatty liver disease (NAFLD) 3 • 66 subjects con
Slide 4: Study Population — Key Eligibility Criteria
Study Population — Key Eligibility Criteria Subjects needed to have completed dosing in the 12 - week Phase 1b NAFLD trial and met the following criteria at parent trial entry: • Men and women, ages 18 - 65 years • BMI ≥ 28 kg/m 2 • NAFLD, defined as liver fat content (LFC) by MRI - PDFF ≥ 10% • Abs
Slide 5: Study Endpoints
Study Endpoints Efficacy • Primary Endpoint: • Reduction in liver fat content (LFC) by MRI - PDFF at Week 24 compared to Week 0 • Key Secondary Endpoints: • Liver inflammation by serum alanine aminotransferase (ALT) levels and corrected T1 (cT1) imaging at Week 24 compared to Week 0 • Percent (%) we
Slide 6: Study Disposition
Study Disposition Placebo n = 24 Pemvi 1.2 mg n = 23 Pemvi 1.8 mg n = 23 Pemvi 2.4 mg n = 24 Completed treatment n = 24 Completed treatment n = 21 Completed treatment n = 20 Completed treatment n = 18 Placebo n = 19 Pemvi 1.2 mg n = 16 Pemvi 2.4 mg n = 14 Pemvi 1.8 mg n = 15 Declined 5 Declined 6 Co
Slide 7: Baseline Characteristics of Extension Study Participants
Baseline Characteristics of Extension Study Participants Characteristic Treatment Placebo (n = 19) 1.2 mg (n=16) 1.8 mg (n=15) 2.4 mg (n=14) Age, years mean (SD) 49.0 (15) 48.6 (11) 49.9 (10) 48.4 (8) Gender female, n (%) 11 (57.9%) 7 (43.8%) 8 (53.3%) 8 (57.1%) Race white, n (%) 17 (89.5%) 14 (87.5
Slide 8: Robust Reduction in Liver Fat Content by MRI-PDFF
Robust Reduction in Liver Fat Content by MRI - PDFF at Week 24 8 Absolute Reduction Relative Reduction *** p < 0.001 vs. placebo, (ANCOVA) Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial, LS mean ± SE
Slide 9: Robust Reduction in Liver Fat Content by MRI-PDFF — Responder Analyses
9 Robust Reduction in Liver Fat Content by MRI - PDFF — Responder Analyses at Week 24 Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial; CMH, Cochran - Mantel - Haenszel 30% Reduction 50% Reduction Normalization (≤5% LFC) * p < 0.05 ** p < 0.005 *** p < 0.001 **** p < 0.0001 vs. placebo (C
Slide 10: Marked Reduction of Liver Fat Content by MRI-PDFF
10 Marked Reduction of Liver Fat Content by MRI - PDFF at Week 24 Pemvidutide 1.8 mg MRI - PDFF Baseline 32.3% Week 24 1.7% This reduction was accompanied by a 38.1% decrease in liver volume
Slide 11: Robust Reduction in Liver Volume by MRI-PDFF
Robust Reduction in Liver Volume by MRI - PDFF at Week 24 11 * p < 0.05 *** p < 0.001 vs. placebo, (ANCOVA) Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial, LS mean ± SE Absolute Reduction Relative Reduction
Slide 12: Robust Reduction of Serum ALT
Robust Reduction of Serum ALT at Week 24 BIOMARKER OF LIVER INFLAMMATION 12 Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial; MMRM, mixed model with repeated measures, LS mean ± SE All Subjects Subjects w/ Baseline ALT ≥ 30 IU/L * p < 0.05 ** p < 0.005 vs. placebo (MMRM)
Slide 13: High Rates of cT1 Response
High Rates of cT 1 Response at Week 24 RESPONSE DEFINED AS AN 80 ms REDUCTION IN c T1 FROM BASELINE 13 Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial; 1 Dennis A, Front Endocrinol 2021; 2 Jayaswal, A. Liver Int 2020; 3 Roca - Fernandez A, MedRxiv 2022; * p < 0.05 ** p < 0.005 vs. placeb
Slide 14: Continued Weight Loss — Efficacy Estimand
14 ** p < 0.005 *** p < 0.001 vs. placebo (MMRM) Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial; MMRM, mixed model with repeated measures, LS mean ± SE Continued Weight Loss at Week 24 — Efficacy Estimand DIFFERENTIATES PEMVIDUTIDE FROM NASH DRUGS WITH COMPARABLE LEVELS OF LIVER FAT RED
Slide 15: Changes in Serum Lipids
15 Changes in Serum Lipids at Week 24 Characteristic Treatment Placebo (n = 19) 1.2 mg (n=16) 1.8 mg (n=15) 2.4 mg (n=14) Total cholesterol, mean (SD) Baseline mg/dL 181.4 (35.7) 184.1 (46.8) 196.8 (38.6) 187.2 (36.0) Week 24 mg/dL 169.4 (44.1) 170.9 (40.1) 173.2 (23.7) 162.0 (33.1) LDL cholesterol,
Slide 16: Improvements in Blood Pressure without Clinically Meaningful Increases in Heart Rate
Improvements in Blood Pressure without Clinically Meaningful Increases in Heart Rate at Week 24 16 Heart Rate Blood Pressure Comparison to Week 0 (Baseline) of the Phase 1b NAFLD trial; MMRM, mixed model with repeated measures, LS mean ± SE * p < 0.05 vs. placebo (MMRM) *
Slide 17: Safety Overview — AEs During 12-Week Extension Study
Characteristic Treatment Placebo (n = 19) 1.2 mg (n=16) 1.8 mg (n=15) 2.4 mg (n=14) Serious or severe AEs n (%) 1 (5.3%) 1 (6.3%) 1 (6.7%) 0 (0.0%) AEs leading to treatment discontinuation n (%) 0 (0.0%) 2 (12.5%) 1 (6.7%) 0 (0.0%) Nausea Mild n (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (7.1%) Moderate n (%)
Slide 18: Glycemic Control
Glycemic Control at Week 24 18 Characteristic Treatment Placebo 1.2 mg 1.8 mg 2.4 mg NON - DIABETES N=14 N=13 N=9 N=11 Fasting glucose Baseline, mg/dL mean (SD) 96.2 (12.4) 99.4 (11.9) 96.0 (12.4) 99.3 (13.6) Week 24, mg/dL mean (SD) 93.3 (12.1) 99.1 (13.1) 96.9 (12.5) 98.4 (24.5) HbA1c Baseline, %
Slide 19: Summary and Conclusions
Summary and Conclusions • Greater than 75% relative liver fat reduction at 24 weeks, better than or equal to the effects of other leading NASH candidates • Significant reductions and normalization in serum ALT and improvement in cT1 point to potent effects in NASH clinical trials • Non - diabetes —
Slide 20: Questions pertaining to this presentation
NASDAQ: ALT Questions pertaining to this presentation: Rich Eisenstadt, CFO reisenstadt@altimmune.com