Slide 1: Phase 2 trial of Falkieri (esketamine DPI) in TR bipolar depression
Phase 2 trial of Falkieri (esketamine DPI) in TR bipolar depression Topline Results 0 1 1 1 2 0 2 1 1
Slide 2: Disclaimer
Disclaimer Neither this presentation (the “Presentation”, references to which shall be deemed to include any information which has been or may be supplied in writing or orally in connection herewith or in connection with any further enquiries) nor any copy of it nor the information contained herein
Slide 3: Bipolar Disorder Factsheet
Bipolar Disorder Factsheet • Bipolar disorder (BD) is one of the most severe psychiatric disorders affecting more than 2% of the global population (6 million adults in the US) • It is characterised by biphasic, recurrent mood episodes of mania/hypomania and depression • Depressive episodes are often
Slide 4: Treatment Resistant Bipolar Depression
Treatment Resistant Bipolar Depression • Small number of treatments that often fail to significantly improve symptoms and functionality • Treatment failure rates often higher than in Major Depressive Disorder (MDD) - unipolar depression • Treatment-resistant Bipolar Depression (TRBD) o no clear cons
Slide 5: Falkieri Phase II TR Bipolar Depression Trial - Design Summary
Falkieri Phase II TR Bipolar Depression Trial - Design Summary Patients TR Bipolar Depression (n=88) 1:1:1:1 Low Dose (24mg) Mid dose(36mg) High dose (48mg) Placebo 3*2 sequence 3*3 sequence 3*4 sequence DPI DPI DPI DPI 4 doses administered over a 14-day period, with 6 weeks of follow-up Primary End
Slide 6: Falkieri Phase 2 in TRBD - Demographics & Baseline Characteristics
Falkieri Phase 2 in TRBD - Demographics & Baseline Characteristics Adult patients age 18-65 years old, with depressive episode in bipolar depression Bipolar depression was considered treatment-resistant if inadequate response to at least two therapies was observed. Esketamine Placebo (N=22) 24 mg 36
Slide 7: Primary Efficacy Endpoint Successfully Met (Change in MADRS Total Score at Week 2)
Falkieri Primary Efficacy Endpoint Successfully Met (Change in MADRS Total Score at Week 2) -8.2* (p<0.001) Esketamine -6.7* (p=0.004) Placebo (N=22) 24 mg 36 mg 48 mg -5.9* (p=0.009) (N=23) (N=21) (N=22) Mean ChfB (SD) -7.0 (6.7) -13.7 (8.3) -14.6 (8.1) -16.5 (6.4) L S m e a n M A D R S T o ta l S
Slide 8: Falkieri Selected Secondary Endpoints
Falkieri Selected Secondary Endpoints Response Remission Hamilton Depression Rating Scale (defined as ≥50% reduction (defined as achieving MADRS (HDRS) from baseline on Day 14) total score ≤10 on Day 14 ) L S m e a n M A D R S T o ta l S c o re % o f re s p o n d e rs o n D a y 1 4 -36* % o f r e m
Slide 9: Efficacy Data in MADRS improvement Compares Favorably to Other Therapies
Falkieri Efficacy Data in MADRS improvement Compares Favorably to Other Therapies Placebo-subtracted difference on MADRS at Week 2 8 6 Recent FDA approved agents (Treatment resistant patients excluded) 4 2 24 36 48 mg 300 600 mg low high low high low high [dose] Falkieri Olanzapine Quetiapine Lurasi
Slide 10: Efficacy Data in Achieving RESPONSE and REMISSION Compares Favorably to Other Therapeutic Options
Falkieri Efficacy Data in Achieving RESPONSE and REMISSION Compares Favorably to Other Therapeutic Options [%] Placebo-subtracted difference on: Response (MADRS ≥50% reduction from baseline) 40 Remission (MADRS ≤10 points) at Week 2 or Study Endpoint 30 Recent FDA approved agents (Treatment resistan
Slide 11: Falkieri Safety Profile in Bipolar Depression
Falkieri Safety Profile in Bipolar Depression ▪ No deaths, no serious side effects, no suicides, no discontinuations due to adverse events, no mania induction at any time point, no sedation ▪ No dose related adverse events (% of subjects with adverse events: Placebo – 27.3%, Esk24 – 39.1%, Esk36 – 2
Slide 12: Safety Profile. Dissociation.
Falkieri Safety Profile. Dissociation. Falkieri bipolar TR depression SPRAVATO 18 C A D S S _ D a y 1 -1 1 CADSS total score over time TRANSFORM-2 (3002) 16 p la c e b o E s k e ta m in e 2 4 m g 14 M e a n ( + /- S D ) C A D S S t o t a l s c o r e E s k e ta m in e 3 6 m g E s k e ta m in e 4 8 m
Slide 13: Falkieri - Differentiated Product Profile
Falkieri - Differentiated Product Profile Phase of Devpt. Indication(s) Administration Dosing (1) Treatment- Spravato Approved Resistant Unipolar In the clinic Intranasal Depression (1)Treatment- Resistant Unipolar Dry Powder Inhaler Acute – in the clinic Depression (potentially more Falkieri Phase
Slide 14: Key Takeaways
Falkieri Key Takeaways ▪ Rapid, substantial and significant improvement in treatment-resistant bipolar depression ▪ Met primary endpoint – highly statistically significant improvement on MADRS versus placebo at Week 2 ▪ Well tolerated and safe treatment with a safety profile consistent with the prev
Slide 15: THANK YOU!
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