Newamsterdam Pharma Company N.v. · NASDAQ:NAMS
Newamsterdam Pharma — Conference Presentation (July 2024)
18 slides from Newamsterdam Pharma's conference presentation, July 2024
Slide 1: BROOKLYN Topline Results
BROOKLYN Topline Results July 2024 Nasdaq: NAMS
Slide 2: Disclaimer
Disclaimer This presentation (together with oral statements made in connection herewith, this “Presentation”) is for informational purposes only. This Presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor shall there be any sale of securities
Slide 3: HeFH Overview
HeFH Overview • Heterozygous familial hypercholesterolemia (“HeFH”), a genetic disorder that affects 1 in 250 persons, or approximately 30 million people worldwide, is characterized by elevated levels of low-density lipoprotein cholesterol (“LDL-C”) from birth. • Without treatment, the condition is
Slide 4: Study Design and Baseline Characteristics
Study Design and Baseline Characteristics Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies: A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants with a History of HeFH and LDL-C ≥70 mg/dL who are Not Adequately Con
Slide 5: Disposition of All Randomized Participants
Disposition of All Randomized Participants Placebo Obicetrapib 10 mg Total Randomized 118 236 354 Completed treatment 101 (85.6) 218 (92.4) 319 (90.1) Discontinued treatment 17 (14.4) 18 (7.6) 35 (9.9) Discontinued due to 7 (5.9) 8 (3.4) 15 (4.2) AE’s Subject decision 4 (3.4) 4 (1.7) 8 (2.3) Withdra
Slide 6: Additional Baseline Details of All Randomized Patients
Additional Baseline Details of All Randomized Patients Placebo Obicetrapib 10 mg Total N=118 N=236 N=354 Mean Age (years) 56.6 57.0 56.9 Sex (F) n (%) 65 (55.1) 125 (53.0) 190 (53.7) Region n (%) EMEA 83 ( 70.3) 182 ( 77.1) 265 ( 74.9) North America 35 ( 29.7) 54 ( 22.9) 89 ( 25.1) Race n (%) White
Slide 7: Additional Baseline Details of All Randomized Patients
Additional Baseline Details of All Randomized Patients Placebo Obicetrapib 10 mg Total N=118 N=236 N=354 Diabetes n (%) Yes 26 ( 22.0) 47 ( 19.9) 73 ( 20.6) No 92 ( 78.0) 189 ( 80.1) 281 ( 79.4) Statin treatment High Dose 80 ( 67.8) 186 ( 78.8) 266 ( 75.1) Low or Moderate Dose 19 ( 16.1) 23 ( 9.7) 4
Slide 8: Statistically Significant LDL-C Reduction Observed at Primary Endpoint of Day 84 and Maintained Through Day 365
Statistically Significant LDL-C Reduction Observed at Primary Endpoint of Day 84 and Maintained Through Day 365 LS Mean % change vs. placebo LDL-C reduction over time (ITT population) 38.2% 41.5% 38.3% 36.3% * * 8 Note: * = p<0.0001. Martin Hopkins mean changes at baseline, day 30, Day 180, Day 270
Slide 9: Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal
Greater Proportion of Patients in Obicetrapib Arm Achieved LDL-C Goal % of patients achieving LDL-C thresholds 9
Slide 10: LDL-C Responder Analysis in Obicetrapib 10mg arm
LDL-C Responder Analysis in Obicetrapib 10mg arm 34% of patients in obicetrapib with >50% LDL-C reduction 10
Slide 11: Results Consistent with Data Reported from the Company's Prior Clinical Trials
Results Consistent with Data Reported from the Company's Prior Clinical Trials 11 Note: LS mean change calculated by PUC. Obicetrapib 10mg for all studies
Slide 12: Overview of Treatment-Emergent Adverse Events – Safety Population
Overview of Treatment-Emergent Adverse Events – Safety Population Placebo N=118 Obicetrapib 10 mg N=234 Total N=352 n (%) n (%) n (%) Any treatment-emergent AEs (TEAEs) 83 ( 70.3) 149 ( 63.7) 232 ( 65.9) Any TEAEs by maximum severity Mild 47 ( 39.8) 84 ( 35.9) 131 ( 37.2) Moderate 28 ( 23.7) 57 ( 24
Slide 13: Overview of Treatment-Emergent Adverse Events >5% in Either Population
Overview of Treatment-Emergent Adverse Events >5% in Either Population Placebo N=118 Obicetrapib 10 mg N=234 Total N=352 n (%) n (%) n (%) Any non-serious treatment-emergent AEs 52 (44.1) 95 (40.6) 147 (41.8) Influenza 7 (5.9) 21 (9.0) 28 (8.0) Covid-19 8 (6.8) 15 (6.4) 23 (6.5) Hypertension 8 (6.8)
Slide 14: Overview of Adverse Events of Special Interest
Overview of Adverse Events of Special Interest Placebo N=118 Obicetrapib N=234 n (%) n (%) AST or ALT > 3 x ULN 0 (0) 0 (0) Bilirubin > 2 x ULN 2 ( 1.7) 0 (0) CK > 5 x ULN 4 ( 3.4) 3 (1.3 ) NODM or worsening of glycemic control 26 (22.0) 48 (20.5) eGFR < 30 mL/min/1.73m2 or a 25% decrease in eGFR fr
Slide 15: Conclusions
Conclusions • Primary endpoint met with LS mean reduction in LDL-C at day 84 versus placebo of 36.3% (p<0.0001). LDL-C reduction sustained at day 365 of 41.5% (p<0.0001) • 77% of patients receiving obicetrapib achieved LDL-C below 100 mg/dl, with 51% below 70 mg/dl, and 24% below 50 mg/dl • 34% of p
Slide 16: Study Design and Baseline Characteristics of Ongoing Phase 3 Trials
Study Design and Baseline Characteristics of Ongoing Phase 3 Trials 1º endpoint – day 84 N = 2532 LDL-C endpoint N = 9541 Obicetrapib 10 mg13-months (2:1 randomization) Obicetrapib 10 mg (1:1 randomization) Placebo Placebo 13-months 54-months Key Inclusion Criteria Key Inclusion Criteria • ASCVD or
Slide 17: Multiple Potential Pivotal Data Readouts in Next Months
Multiple Potential Pivotal Data Readouts in Next 12 Months 2022 2023 2024 2025 2026 1H 2H 1H 2H 1H 2H 1H 2H 1H 2H Phase 3 BROADWAY Trial Lipid Mono Study BROADWAY Ph3 (HeFH or ASCVD; LDL-C ≥ 55 mg/dL; n=2,532) LDL regulatory filing Phase 3 BROOKLYN Trial BROOKLYN Ph3 Lipid Mono Study Obicetrapib (He
Slide 18: BROOKLYN LDL-C Reduction Applied to PREVAIL Baseline Data Continues to Suggest Hypothetical 20%+ MACE Benefit
BROOKLYN LDL-C Reduction Applied to PREVAIL Baseline Data Continues to Suggest Hypothetical 20%+ MACE Benefit LDL-C at day 84 103 36% 37 mg/dL(1) mg/dL LDL-C LDL-C lowering in Expected to result in PREVAIL BROOKLYN more absolute LDL-C baseline reduction 22% Estimated MACE** benefit drop LDL-C at day
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