Axsome Therapeutics, Inc. · NASDAQ:AXSM
Axsome Therapeutics — STRIDE-1 Phase 3 Trial of AXS-05 in TRD Topline Results Conference Call (March 2020)
24 slides from Axsome Therapeutics's conference presentation, Mar 30, 2020
Slide 1: STRIDE-1 Phase 3 Trial of AXS-05 in TRD Topline Results Conference Call
STRIDE-1 Phase 3 Trial of AXS-05 in TRD Topline Results Conference Call March 30, 2020
Slide 2: STRIDE-1 Phase 3 Trial Topline Results
STRIDE-1 Phase 3 Trial Topline Results Introduction Mark Jacobson, Chief Operating Officer Overview and Summary Herriot Tabuteau, MD, Chief Executive Officer STRIDE-1 Trial Design & Results Cedric O’Gorman, MD, Senior Vice President, Clinical Development & Medical Affairs KOL Perspective of STRIDE-1
Slide 3: Forward-Looking Statements & Safe Harbor
Forward-Looking Statements & Safe Harbor Certain information contained in this presentation may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “
Slide 4: Summary and Overview
Summary and Overview Herriot Tabuteau, MD Chief Executive Officer Axsome Therapeutics, Inc.
Slide 5: Summary of Topline Results: Rapid and Significant Effects with AXS-05 in TRD Patients
Summary of Topline Results: Rapid and Significant Effects with AXS-05 in TRD Patients • AXS-05: a novel, oral, investigational NMDA receptor antagonist with multimodal activity • Rapid and statistically significant improvements in MADRS versus bupropion at W eeks 1, 2, and overall (key secondary end
Slide 6: Treatment Resistant Depression (TRD): Urgent Unmet Medical Need
Treatment Resistant Depression (TRD): Urgent Unmet Medical Need • Depression is a disabling and potentially life-threatening, biologically-based disorder • 17 million U.S. adults experience major depressive episodes each year and at least one-third of them are considered treatment resistant1,2 • Pat
Slide 7: AXS-05: Novel, Oral, NMDA Receptor Antagonist with Multimodal Activity
AXS-05: Novel, Oral, NMDA Receptor Antagonist with Multimodal Activity + 2+ A Receptor Modulation of Na /Ca tagonism DM Delivery AXS-05 NMDA receptor DM component of AXS-05 Mg2+ AXS-05 Cell DM membrane K+ dextromethorphan/bupropion modulated delivery tablet Time Sigma-1 Receptor Agonism Monoamine Re
Slide 8: STRIDE-1 Phase 3 Trial Design & Results
STRIDE-1 Phase 3 Trial Design & Results Cedric O’Gorman MD, MBA Senior Vice President, Clinical Development and Medical Affairs Axsome Therapeutics, Inc.
Slide 9: A Phase 3 trial to assess the efficacy and safety of AXS-05 in the treatment of TRD
A Phase 3 trial to assess the efficacy and safety of AXS-05 in the treatment of TRD 1:1 randomization of inadequate responders Period 1, Open-label (6 weeks) Period 2, Double-blind (6 weeks) Baseline Week 1 Week 2 Week 4 Week 6 N=799 Open-Label Bupropion (150 mg BID) N=156 N=156 AXS-05 (45 mg DM / 1
Slide 10: Inclusion and exclusion criteria
Inclusion criteria included: Open-label Period – Male or female 18-65 years of age inclusive – History of inadequate response to 1 or 2 prior antidepressant treatments, established by ATRQ – Hamilton Depression Rating Scale (HAMD-17) total score of ≥ 18 Double-blind Period – Inadequate response to 2
Slide 11: Demographics and baseline characteristics
AXS-05 (45 mg DM / 105 mg BUP) Bupropion (150 mg) Age (years) 44.3 (12.19) 45.1 (12.56) Female Gender, n (%) 101 (65.6%) 97 (62.6%) Race, n (%) White Black or African American Asian Other or Not Reported 100 (64.9%) 41 (26.6%) 2 (1.3%) 11 (7.1%) 106 (68.4%) 39 (25.2%) 6 (3.9%) 4 (2.6%) BMI (mg/kg2)
Slide 12: Change in MADRS total score
0 AXS-05 (45 mg dextromethorphan / 105 mg bupropion BID) Bupropion (150 mg BID) -2 -4 -6 P=0.020 -8 -10 -12 -14 P=0.035 Overall (6-week averaged) P= 0.031 P=0.105 P=0.117 Baseline 1 2 3 4 5 6 Week AXS-05 Bupropion (n=154) (n=155) Difference P-Value Primary Endpoint: Change in MADRS Total Score at We
Slide 13: Change in QIDS-SR-16 score
0 AXS-05 (45 mg dextromethorphan / 105 mg bupropion BID) Bupropion (150 mg BID) -1 -2 P=0.055 -3 -4 P=0.025 -5 Overall (6-week averaged) P= 0.013 -6 P= 0.018 P= 0.057 Baseline 1 2 3 4 5 6 Week Notes: P-values calculated from LSMean. Abbreviations: BID = twice daily; QIDS-SR-16 = Quick Inventory of D
Slide 14: Remission rates on QIDS-SR-16
20% 18% P=0.012 18.2% 16% 14% 12% 10% 8% 6% 4% 2% 0% P=0.001 6.5% 0.0% P=0.009 9.9% 2.6% P=0.015 10.6% 3.4% 8.2% Week 1 Week 2 Week 4 Week 6 AXS-05 (45 mg dextromethorphan / 105 mg bupropion BID) Bupropion (150 mg BID)
Slide 15: Cognitive function on the MGH-CPFQ
Cognitive items of the CPFQ assess sharpness/mental acuity, and the ability to focus/maintain attention, to remember/recall information, and to find words • Each of the 4 items on the cognitive dimension of the CPFQ are scored 1-6, with lower scores representing improvements in cognitive functioning
Slide 16: Treatment-emergent adverse events
Double-blind Periodb Open-label Period AXS-05 Bupropion (N = 154) (N = 156) Bupropion (n=310) Any TEAEa 67 (43.5%) 61 (39.1%) Dizziness 13 (8.4%) 0 Nausea 8 (5.2%) 3 (1.9%) Dry mouth 6 (3.9%) 3 (1.9%) Headache 4 (2.6%) 7 (4.5%) Insomnia 3 (1.9%) 5 (3.2%) Constipation 3 (1.9%) 3 (1.9%) Anxiety 2 (1.3
Slide 17: AXS-05 met key secondary endpoints in treatment resistant depression
AXS-05 met key secondary endpoints by rapidly improving symptoms of depression in patients with treatment resistant depression (TRD) • AXS-05 demonstrated numerical improvement on primary endpoint (MADRS at Week 6) versus active comparator, but did not reach statistical significance • Statistically
Slide 18: KOL Perspective on STRIDE-1 Data
KOL Perspective on STRIDE-1 Data Professor Maurizio Fava, MD Psychiatrist-in-Chief at Massachusetts General Hospital (MGH) Director of the Division of Clinical Research of the MGH Research Institute Associate Dean for Clinical & Translational Research at Harvard Medical School
Slide 19: BQ3A
BQ3A E THERAPEUTICS Treapet 7
Slide 20: Concluding Remarks
AXSOME THERAPEUTICS Concluding Remarks Herriot Tabuteau, MD Chief Executive Officer Axsome Therapeutics, Inc.
Slide 21: Clinical Program
Clinical Program ASCEND GEMINI STRIDE-1 AXS-05 / OL ADVANCE-1 Indication MDD MDD TRD MDD/TRD AD Agitation Phase Pivotal Phase 2 Pivotal Phase 3 Pivotal Phase 3 Open-label Phase 3 Pivotal Phase 2/3 Objectives Efficacy of AXS-05 vs. BUP Efficacy of AXS-05 vs. PBO Efficacy of AXS- 05 vs. BUP Long-term
Slide 22: Five differentiated clinical-stage CNS assets
• Five differentiated clinical-stage CNS assets targeting significant and growing markets • Patent protection to 2034-2036, worldwide rights for most product candidates Product Candidat e Phase 1 Phase 2 Phase 3 NDA AXS-05 (DM + BUP) AXS-07 (MoSEIC™ Mx + Riz) AXS-12 (Reboxetine) AXS-14 (Esreboxetine
Slide 23: 2020 milestones by product candidate
Product Candidate Indication 2020 AXS-05 (DM + BUP) MDD ● NDA submission (4Q) TRD ● STRIDE-1 topline results AD Agitation ✓ ADVANCE-1 Phase 2/3 topline results (early 2Q) Smoking Cessation ● FDA meeting (2020) AXS-07 (MoSEIC™ Mx + Riz) Migraine ● INTERCEPT Phase 3 topline results (imminent) ● NDA su
Slide 24: For more information, please contact
For more information, please contact Mark Jacobson Chief Operating Officer 212-332-3243 mjacobson@axsome.com axsome.com