Slide 1: MOMENTUM—Pemvidutide Phase 2 Obesity Trial Week 24 Interim Analysis
MOMENTUM—Pemvidutide Phase 2 Obesity Trial Week 24 Interim Analysis NASDAQ: ALT M. Scott Harris, MD, Chief Medical Officer Louis Aronne, MD, Principal Investigator Sanford I. Weill Professor of Metabolic Research Professor of Clinical Medicine, Weill Cornell Medicine 21 March 2023
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 statements
Slide 3: MOMENTUM Trial Design
MOMENTUM Trial Design • Phase 2, 48-week trial of pemvidutide in approx 320 subjects with overweight or obesity • Randomized 1:1:1:1 to 1 of 4 treatment arms, stratified by sex and baseline BMI, with standard lifestyle interventions • No or rapid (4 week) dose titration; dose reduction due to intole
Slide 4: Study Population—Key Eligibility Criteria
Study Population—Key Eligibility Criteria • Men and women ages 18-75 years • BMI ≥ 30 kg/m2 or BMI ≥ 27 kg/m2 with at least one obesity-related comorbidity - History of cardiovascular disease - Hypertension - Dyslipidemia - Pre-diabetes - Obstructive sleep apnea • Non-diabetes: HbA1c ≤ 6.5% and fast
Slide 5: Study Endpoints
Study Endpoints Efficacy • Primary Endpoint: • Relative change from baseline in body weight (%) • Key Secondary Endpoints: • Proportions (%) of subjects achieving weight loss of ≥ 5%, ≥ 10% and ≥ 15% body weight • Change from baseline in waist circumference, serum lipids, blood pressure Safety • Adv
Slide 6: Disposition of Subjects in Interim Analysis
Disposition of Subjects in Interim Analysis 160 randomized and dosed Placebo n = 39 Pemvi 1.2 mg n = 40 Pemvi 1.8 mg n = 40 Pemvi 2.4 mg n = 41 Completed treatment n = 28 Completed treatment n = 33 Completed treatment n = 26 3 adverse event 3 withdrawal consent 1 lost to follow-up 4 adverse event 2
Slide 7: Baseline Characteristics of Subjects in Interim Analysis
Baseline Characteristics of Subjects in Interim Analysis 7 Characteristic Treatment Placebo (n = 39) 1.2 mg (n=40) 1.8 mg (n=40) 2.4 mg (n=41) Age, years mean (SD) 46.7 (14.2) 46.5 (12.0) 49.5 (13.5) 48.2 (13.4) Gender female, n (%) 30 (76.9%) 31 (77.5%) 30 (75.0%) 31 (75.6%) Race white, n (%) 31 (7
Slide 8: Substantial Weight Loss Through Week 24
Substantial Weight Loss Through Week 24 INTERIM DATA DEMONSTRATES PROMISING WEIGHT LOSS TRENDS 8 Efficacy Estimand MMRM, mixed model for repeated measures *** p < 0.001 vs. placebo (MMRM)
Slide 9: Weight Loss Responder Analysis at Week 24
Weight Loss Responder Analysis at Week 24 50% OF SUBJECTS LOST 10% BODY WEIGHT AT 24 WEEKS 9 * p < 0.05 ** p < 0.005 *** p < 0.001 **** p < 0.0001 vs. placebo (CMH) CMH, Cochran–Mantel–Haenszel
Slide 10: Impact of Baseline Body Weight on Efficacy
10 Impact of Baseline Body Weight on Efficacy GREATER MEAN WEIGHT LOSS IN SUBJECTS WITH BASELINE BODY WEIGHT ≤115 kg Efficacy Estimand N =120 (75% of study population) *** p < 0.001 vs. placebo (MMRM) Efficacy Estimand MMRM, mixed model for repeated measures
Slide 11: Significant Reductions in Waist Circumference at Week 24
Significant Reductions in Waist Circumference at Week 24 REDUCTIONS IN CENTRAL OBESITY—A MARKER FOR VISCERAL FAT 11 ** p < 0.005 *** p < 0.001 vs. placebo (MMRM) MMRM, mixed model for repeated measures
Slide 12: Robust Reduction in Serum Lipids at Week 24
Robust Reduction in Serum Lipids at Week 24 12 ** p < 0.005 *** p < 0.001 vs. placebo (ANCOVA) ANCOVA, analysis of covariance
Slide 13: Improvements in Blood Pressure without Meaningful Changes in Heart Rate Through Week 24
Improvements in Blood Pressure without Meaningful Changes in Heart Rate Through Week 24 13 Blood Pressure Heart Rate MMRM, mixed model for repeated measures
Slide 14: Safety Overview—AEs Through Week 24
14 Safety Overview—AEs Through Week 24 1Rehydration for nausea and vomiting Characteristic Treatment Placebo (n = 39) 1.2 mg (n=40) 1.8 mg (n=40) 2.4 mg (n=41) Serious adverse events n (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 1 (2.4%)1 AEs leading to treatment discontinuation n (%) 1 (2.6%) 3 (7.5%) 4 (10.0%)
Slide 15: Glucose Homeostasis Maintained Through Week 24
Glucose Homeostasis Maintained Through Week 24 15 Characteristic Treatment Placebo (n = 39) 1.2 mg (n=40) 1.8 mg (n=40) 2.4 mg (n=41) ALL SUBJECTS Fasting glucose Baseline, mg/dL mean (SD) 96.1 (9.8) 97.0 (12.2) 103.1 (12.1) 100.3 (12.9) Week 24, mg/dL mean (SD) 97.7 (11.4) 96.0 (11.2) 103.9 (14.4)
Slide 16: Summary and Conclusions
Summary and Conclusions Efficacy • 10.7% and 9.4% (placebo-adjusted: 9.7% and 8.4%) weight loss at 2.4 mg and 1.8 mg through Week 24 • 11.9% and 10.6% (placebo-adjusted:11.1% and 9.8%) weight loss at 2.4 mg and 1.8 mg through Week 24 in subjects with baseline body weight ≤ 115 kg • Approximately 50%
Slide 17: 12-Week Phase 1b Trial of Pemvidutide in Subjects with Obesity or Overweight and Type 2 Diabetes
12-Week Phase 1b Trial of Pemvidutide in Subjects with Obesity or Overweight and Type 2 Diabetes NASDAQ: ALT
Slide 18: Pemvidutide Phase 1b Type 2 Diabetes Safety Trial
Pemvidutide Phase 1b Type 2 Diabetes Safety Trial • 54 subjects randomized 1:1:1:1 to 1 of 4 treatment arms, stratified by the presence or absence of metformin use at baseline • 12-week, randomized, placebo-controlled study of pemvidutide in subjects with obesity or overweight and type 2 diabetes 18
Slide 19: Study Population—Key Eligibility Criteria
Study Population—Key Eligibility Criteria • Men and women, ages 18-65 years • BMI ≥ 28 kg/m2 • Type 2 diabetes on stable glucose control regimen for at least 3 months prior to screening • Glucose control regimens included at least one of the following: – Diet and exercise – Metformin with absent or
Slide 20: Disposition of Subjects
Disposition of Subjects Placebo n = 14 Pemvi 1.2 mg n = 14 Pemvi 1.8 mg n = 13 Pemvi 2.4 mg n = 13 Completed treatment n = 14 Completed treatment n = 12 Completed treatment n = 9 1 withdrawal consent Completed treatment n = 11 54 randomized and dosed 1 withdrawal consent 1 non-compliance 2 lost to f
Slide 21: Substantial Weight Loss Through Week 12
Substantial Weight Loss Through Week 12 21 *** p < 0.001 vs. placebo, (MMRM) MMRM, mixed model for repeated measures Efficacy Estimand
Slide 22: Glucose Homeostasis Maintained Through Week 12
22 Characteristic Treatment Placebo (n=14 ) 1.2 mg (n=14 ) 1.8 mg (n=13 ) 2.4 mg (n= 13) ALL SUBJECTS Fasting glucose Baseline, mg/dL mean (SD) 140.9 (41.6) 132.6 (25.0) 124.9 (31.0) 128.2 (22.8) Week 12, mg/dL mean (SD) 140.4 (45.4) 132.0 (32.8) 126.2 (15.7) 140.6 (28.7) HbA1c Baseline, % mean (SD)
Slide 23: Safety Overview—AEs Through Week 12
23 Safety Overview—AEs Through 12 Weeks Characteristic Treatment Placebo (n = 14) 1.2 mg (n=14) 1.8 mg (n=13) 2.4 mg (n=13) Serious adverse events n (%) 1 (7.1%)1 0 (0.0%) 0 (0.0%) 0 (0.0%) AEs leading to treatment discontinuation n (%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Hyperglycemia AEs n (%) 0 (
Slide 24: Summary and Conclusions
Summary and Conclusions Safety and tolerability • Excellent tolerability with low GI AE rates • No discontinuations due to AEs 24 Glucose control • Glucose homeostasis maintained, with no significant changes in fasting glucose or HbA1c through Week 12 • No hyperglycemia AEs Weight loss • 7.7% (place
Slide 25: Questions pertaining to this presentation
NASDAQ: ALT Questions pertaining to this presentation: Rich Eisenstadt, CFO reisenstadt@altimmune.com