Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — 2020 American Academy of Neurology Science Highlights Emerging Science Presentation
16 slides from Axsome Therapeutics's conference presentation, Sep 23, 2020
Slide 1: Efficacy and Safety of AXS-07 in the Acute Treatment of Migraine: MOMENTUM Phase 3 Results
Efficacy and Safety of AXS-07 (MoSEIC™ Meloxicam/Rizatriptan) in the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3 Trial Amanda Jones3, Cedric O’Gorman3, Richard B. Lipton1, Stewart J. Tepper2, Herriot Tabuteau3 1Albert Einstein College of Medicine, New York, NY, USA; 2Geisel School
Slide 2: AXS-07: Multi-Mechanistic Treatment for Migraine
Migraine AXS-07 (MoSEIC™ Meloxicam/Rizatriptan): Multi-Mechanistic Treatment for Migraine CGRP MEDIATED1 NEUROINFLAMMATION2 AXS-07 Migraine Process Mechanism / Action Component Inhibition of CGRP release CGRP Mediated Rizatriptan Reversal of CGRP- mediated vasodilation Cyclooxygenase inhibitio
Slide 3: Temporal Alignment: AXS-07 PK versus CGRP and PGE2 Increases
Migraine Temporal Alignment: AXS-07 PK versus CGRP and PGE2 Increases Temporal Alignment of AXS-07 Pharmacokinetics and CGRP and PGE2 Increases During Migraine Attacks in Human Subjects Sarchielli et al. Cephalalgia. 2000;20:907-18. Abbreviations: CGRP, Calcitonin gene-related peptide; PGE2, Prostag
Slide 4: MOMENTUM Phase 3 Trial: Design Summary
MOMENTUM MOMENTUM Phase 3 Trial: Design Summary MOMENTUM: Maximizing OutcoMEs iN Treating acUte Migraine Phase 3 study of AXS-07 for the acute treatment of migraine in adults with history of inadequate response to prior treatment Screening Single dose, following a qualifying migraine AXS-07 n=456 (2
Slide 5: MOMENTUM Phase 3 Trial: Key Entry Criteria
MOMENTUM MOMENTUM Phase 3 Trial: Key Entry Criteria Inclusion Criteria • Male or female, 18 to 65 years of age, inclusive • Established diagnosis (at least 1 year) of migraine with or without aura as defined by the ICHD-3 criteria • An average 2 to 8 moderate to severe migraines per month, on averag
Slide 6: MOMENTUM Baseline Characteristics: Difficult-to-Treat Migraine
MOMENTUM MOMENTUM Baseline Characteristics: Difficult-to-Treat Migraine AXS-07 MoSEIC (20 mg MoSEIC Mlx / Rizatriptan Meloxicam 10 mg Riz) (10 mg) (20 mg) Placebo n=428 n=419 n=421 n=209 Age, years 41.2 (11.52) 41.4 (10.68) 41.0 (12.07) 40.8 (11.47) Female gender, n (%) 346 (80.8%) 353 (84.2%) 355 (
Slide 7: AXS-07 Achieved Co-Primary Endpoints: Pain and MBS Improvement
MOMENTUM AXS-07 Achieved Co-Primary Endpoints: Pain and MBS Improvement Pain Freedom at 2 hour vs. Placebo MBS Freedom at 2 hours vs. Placebo AXS-07 Placebo Endpoints Difference P-Value (n=428) (n=209) Co-Primary Endpoint 1: Pain Freedom 2 19.9% 6.7% -13.2% <0.001 Hours after Dose, % Co-Primary Endp
Slide 8: Pain Freedom Rates Over Time
MOMENTUM Pain Freedom Rates Over Time: Significant Improvements in Pain Freedom 70 P<0.001 P<0.001 P<0.001 P<0.001 P=0.019 Percent of Subjects Achieving Pain Freedom 60 P=0.018 58.2 56.5 P<0.001 50 P<0.001 50.1 48.4 P=0.04 45.8 43.9 40 39.5 37.8 30 32.7 32.5 P<0.001 P=0.001 24.7 20 19.9 18.7 17.4 10
Slide 9: Rapid Relief of Migraine Pain: Time to Pain Relief
MOMENTUM Rapid Relief of Migraine Pain: Time to Pain Relief 100 AXS-07 AXS-07 (N=428)(N=428) Censored Censored Rizatriptan (N=419) 90 Rizatriptan (N=419) Meloxicam (N=421) Meloxicam Placebo (N=421) (N=209) Probability of Pain Relief (%) 80 Placebo (N=209) 70 60 50 40 30 20 P-values, Log-Rank Test P-
Slide 10: Sustained Pain Freedom Greater with AXS-07
MOMENTUM Sustained Pain Freedom Greater with AXS-07 • 77% of patients treated with AXS-07 who achieved migraine pain freedom at Hour 2 maintained it through Hour 48 © Axsome Therapeutics, Inc. 10
Slide 11: Sustained Pain Relief Greater with AXS-07
MOMENTUM Sustained Pain Relief Greater with AXS-07 • A significantly greater percentage of patients who achieved relief of migraine pain at Hour 2 with AXS-07 maintained it through Hour 48 as compared to active and placebo controls © Axsome Therapeutics, Inc. 11
Slide 12: Pain Relapse Significantly Reduced with AXS-07
MOMENTUM Pain Relapse Significantly Reduced with AXS-07 50% P=0.001 45% Percent of Subjects with Relapse of Pain 45.2% 40% 35% 30% 25% 20% 21.2% 15% 10% 5% 0% Relapse of Migraine Pain within 48 Hours Rizatriptan AXS-07 • AXS-07 reduced pain relapse by more than 50% compared to rizatriptan over 48 ho
Slide 13: Rescue Medication Use Significantly Reduced with AXS-07
MOMENTUM Rescue Medication Use Significantly Reduced with AXS-07 50% P<0.001 Took Rescue Medication Through Hour 24 P<0.001 43.5% 40% P<0.001 Percentage of Subjects Who 35.1% 34.7% 30% 20% 23.0% 10% 0% Placebo MoSEIC Meloxicam Rizatriptan AXS-07 • Rescue medication was required by 50% more rizatript
Slide 14: Multiple Efficacy-Related Endpoints: AXS-07 Superiority Over Rizatriptan
MOMENTUM Multiple Efficacy-Related Endpoints: AXS-07 Superiority Over Rizatriptan Results* Clinically Significant Endpoint AXS-07 Rizatriptan P-value Time to Pain Relief (probability of relief greater with AXS-07 1.5 hours 4.0 hours <0.001 starting at 30 mins, median times shown) 24-hour Sustained P
Slide 15: Safety of AXS-07: Adverse Events Occurring in ≥2% of Subjects
MOMENTUM Safety of AXS-07: Adverse Events Occurring in ≥2% of Subjects AXS-07 Rizatriptan Meloxicam Placebo (N = 441) (N = 434) (N = 433) (N = 218) Any Treatment-Emergent AE 49 (11.1%) 67 (15.4%) 50 (11.5%) 13 (6.0%) Nausea 12 (2.7%) 21 (4.8%) 14 (3.2%) 8 (3.7%) Dizziness 7 (1.6%) 9 (2.1%) 5 (1.2%)
Slide 16: MOMENTUM Phase 3 Trial Results: Conclusions
MOMENTUM MOMENTUM Phase 3 Trial Results: Conclusions • AXS-07 resulted in rapid, substantial, and sustained pain relief compared to rizatriptan, MoSEIC™ meloxicam, and placebo in patients with a history of inadequate response to prior acute migraine treatments • Low placebo response for pain freedom