A 5-HT 6 antagonist in advanced development for the treatment of mild and moderate Alzheimer s disease: idalopirdine (Lu AE58054)
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1 A 5-HT 6 antagonist in advanced development for the treatment of mild and moderate Alzheimer s disease: idalopirdine (Lu AE58054) producti Congrès National des unités de soins, d'évaluation et de prise en charge Alzheimer décembre 2014 Issy-les-Moulineaux Neli BONEVA, MD, PhD 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp ICR Neurology Lundbeck s d évaluation et de prise en charge Alz Tproduction ite.
2 Overview Preclinical data and rationale for 5-HT 6 receptor antagonism via novel compound idalopirdine Results of idalopirdine (Lu AE58054) Phase II study in moderate Alzheimer s disease (AD) producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Overview of Phase III safety and efficacy program in mild and moderate AD 2 s d évaluation et de prise en charge Alz Tproduction ite.
3 Hypothesized MoA of idalopirdine 5-HT Excitatory transmission Idalopirdine 5-HT GLU and/or GABA (inter) neurons Cognition 5-HT 6 receptor Neurotransmission ACh, GLU, (DA, 5-HT) Tonic inhibition (GABA) 5-HT=serotonin; GABA=gamma aminobutyric acid; ACh=acetylcholine; DA=dopamine; MoA=mode of action In the frontal cortex and hippocampus of rats, 5-HT 6 antagonism by idalopirdine: Impacts multiple neurotransmitters Facilitation of cholinergic, glutamatergic and, likely, monoaminergic signaling Suppression of GABAergic transmission producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Facilitates neuronal activity Induces, augments and prolongs cortical theta and gamma oscillations in association with donepezil Added effects in combination with donepezil 3 s d évaluation et de prise en charge Alz Tproduction ite.
4 Idalopirdine Phase II study objectives Primary objective To explore the effect of a fixed dose of idalopirdine (90 mg/day) on cognitive performance (ADAS-Cog) after 24 weeks, compared with placebo (parallel group design), in donepezil-treated patients with moderate AD Secondary objectives Safety and tolerability Efficacy outcomes including: producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Global impression (ADCS-CGIC) Activities of daily living (ADCS-ADL 23 ) Behavioral symptoms (NPI) Power/sample size objectives To detect a 2 point ADAS-Cog (primary measure) change from baseline at Week 24 for completers (based on MMRM analysis SD of 6, a withdrawal rate of 15%, p=0.05 (2-sided), with power of 72%) need minimum of 135 patients in each treatment group Exploratory analysis of secondary measures ADAS-Cog=Alzheimer s Disease Assessment Scale, cognitive subscale; ADCS- CGIC=Alzheimer s Disease Cooperative Study Clinical Global Impression of Change; ADCS-ADL 23 =Alzheimer s Disease Cooperative Study Activities of Daily Living, 23-item scale; MMRM=Mixed Model for Repeated Measures; NPI=Neuropsychiatric Inventory Wilkinson et al. Lancet Neurology 2014;13(11): s d évaluation et de prise en charge Alz Tproduction ite.
5 Idalopirdine in Alzheimer s disease Phase II study design Baseline/randomisation: n=278 Patients with moderate AD (MMSE 12 19) On stable donepezil treatment (10 mg/day) Donepezil Screening period (2 weeks) Idalopirdine 90 mg/day + donepezil producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp + donepezil Double-blind treatment period (24 weeks) 5 Donepezil Safety follow-up (4 weeks) s d évaluation et de prise en charge Alz Tproduction ite. MMSE=Mini-Mental State Examination Wilkinson et al. Lancet Neurology 2014;13(11):
6 Baseline characteristics Donepezil + placebo (n=133) 6 Donepezil + idalopirdine (n=145) Age, years a 75 (7.2) 74 (7.5) Gender, % male Duration of AD, years a 2.2 (1.9) 2.1 (1.8) producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Duration of donepezil use, years a 1.5 (1.6) 1.4 (1.6) MMSE b 17 (16; 19) 17 (15; 18) ADAS-Cog b 28 (20; 36) 28 (21; 34) a Mean (SD); b Mean (25%; 75% percentile) s d évaluation et de prise en charge Alz Tproduction ite. Wilkinson et al. Lancet Neurology 2014;13(11):
7 Primary endpoint cognition Adjusted mean change from baseline ADAS-Cog p= Week 7 Donepezil + placebo Donepezil + idalopirdine p=0.004 producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Worsening s d évaluation et de prise en charge Alz Tproduction ite. Wilkinson et al. Lancet Neurology 2014;13(11):
8 Adjusted mean change from baseline Secondary endpoints functional and global outcomes ADCS-ADL 23 p=0.243 producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Donepezil + placebo Donepezil + idalopirdine Week p= Adjusted post-baseline scores Worsening 3,8 4,0 4,2 4,4 4,6 ADCS-CGIC p=0.020 Donepezil + placebo Donepezil + idalopirdine Week p=0.116 s d évaluation et de prise en charge Alz Tproduction ite. Wilkinson et al. Lancet Neurology 2014;13(11):
9 Safety Generally safe and well tolerated Comparable incidence of SAEs in the two treatment arms Safety most common adverse events ( 5%) ALAT=alanine aminotransferase; GGT=gamma-glutamyltransferase; SAE=serious adverse event Wilkinson et al. Lancet Neurology 2014;13(11): Donepezil + placebo (n=133) No. patients (%) producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Donepezil + idalopirdine (n=145) GGT increased 2 (2) 14 (10) ALAT increased 0 (0) 9 (6) Diarrhea 9 (7) 6 (4) Fall 8 (6) 3 (2) Urinary tract infection 9 (7) 3 (2) Benign prostatic hyperplasia (% men) 0 (0) 2 (5) s d évaluation et de prise en charge Alz Tproduction ite.
10 A Phase III efficacy and safety and clinical trial program of the selective 5- HT 6 antagonist, idalopirdine, in mild and moderate Alzheimer s disease producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp s d évaluation et de prise en charge Alz Tproduction ite. 10
11 Idalopirdine Phase III safety & efficacy program In mild and moderate AD (MMSE 12 22) producti As add-on to any ChEI (not just donepezil in one study) Lower dosing than Phase II 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp ChEI=cholinesterase inhibitor 11 s d évaluation et de prise en charge Alz Tproduction ite.
12 Phase III program Lundbeck & Otsuka Clinical development plan (ongoing trials) Treatment population: mild to moderate AD (MMSE = 12 22) Study 14861A STARSHINE N=930 Screening Doses/ comparator 30 mg/day 60 mg/day Donepezil Baseline Background treatment =randomised, controlled trial; CGIC=Clinical Global Impression of Change; ADL=Activities of Daily Living 12 Treatment duration Total population Key efficacy endpoints Donepezil 24 weeks 930 (310/arm) ADAS-Cog, ADL, CGIC Idalopirdine 60 mg/day + donepezil producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Idalopirdine 30 mg/day + donepezil + donepezil Double-blind treatment period (24 weeks) Completion Donepezil s d évaluation et de prise en charge Alz Tproduction ite. ClinicalTrials.gov; Study identifiers: NCT ; NCT ; NCT
13 Phase III program Lundbeck & Otsuka Clinical development plan (ongoing trials) Treatment population: mild to moderate AD (MMSE = 12 22) Study 14861A STARSHINE 14862A STARBEAM Screening Doses/ comparator 30 mg/day 60 mg/day 10 mg/day 30 mg/day Donepezil Background treatment =randomised, controlled trial; CGIC=Clinical Global Impression of Change; ADL=Activities of Daily Living 13 Treatment duration Total population Key efficacy endpoints Donepezil 24 weeks 930 (310/arm) ADAS-Cog, ADL, CGIC Donepezil 24 weeks 840 (280/arm) ADAS-Cog, ADL, CGIC producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp N=840 Baseline Idalopirdine 30 mg/day + donepezil Idalopirdine 10 mg/day + donepezil + donepezil Double-blind treatment period (24 weeks) Completion Donepezil s d évaluation et de prise en charge Alz Tproduction ite. ClinicalTrials.gov; Study identifiers: NCT ; NCT ; NCT
14 Phase III program Lundbeck & Otsuka Clinical development plan (ongoing trials) Treatment population: mild to moderate AD (MMSE = 12 22) Study 14861A STARSHINE 14862A STARBEAM 14863A STARBRIGHT Screening Doses/ comparator 30 mg/day 60 mg/day 10 mg/day 30 mg/day 60 (30) mg/day AChEI Background treatment AChEI=acetylcholinesterase inhibitor; =randomised, controlled trial; CGIC=Clinical Global Impression of Change; ADL=Activities of Daily Living 14 Treatment duration Total population Key efficacy endpoints Donepezil 24 weeks 930 (310/arm) ADAS-Cog, ADL, CGIC Donepezil 24 weeks 840 (280/arm) ADAS-Cog, ADL, CGIC producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp N=720 Baseline Donepezil, rivastigmine, galantamine Idalopirdine 60 mg/day + AChEI + AChEI Double-blind treatment period (24 weeks) 24 weeks 720 (360/arm) ADAS-Cog, ADL, CGIC Completion AChEI s d évaluation et de prise en charge Alz Tproduction ite. ClinicalTrials.gov; Study identifiers: NCT ; NCT ; NCT
15 Phase III program Lundbeck & Otsuka Clinical development plan (ongoing trials) Treatment population: mild to moderate AD (MMSE = 12 22) Study 14861A STARSHINE 14862A STARBEAM 14863A STARBRIGHT 14861B Open-label extension a Doses/ comparator 30 mg/day 60 mg/day 10 mg/day 30 mg/day 60 (30) mg/day Background treatment a Extension of 14861A, and 14862A; =randomised, controlled trial; CGIC=Clinical Global Impression of Change; ADL=Activities of Daily Living 15 Treatment duration Total population Donepezil 24 weeks 930 (310/arm) Donepezil 24 weeks 840 (280/arm) producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Donepezil, rivastigmine, galantamine 24 weeks 720 (360/arm) Key efficacy endpoints ADAS-Cog, ADL, CGIC ADAS-Cog, ADL, CGIC ADAS-Cog, ADL, CGIC 60 (30) mg/day Donepezil 28 weeks Up to 1,770 ADAS-Cog, ADL, CGIC s d évaluation et de prise en charge Alz Tproduction ite. ClinicalTrials.gov; Study identifiers: NCT ; NCT ; NCT
16 Conclusion 5-HT 6 receptor antagonism represents a novel approach to the treatment of AD that likely affects several neurotransmitter systems (ACh, glutamate, dopamine, GABA), and networks that support cognition, function and behavior In Phase II, idalopirdine (Lu AE58054), when administered as adjunctive treatment to donepezil in patients with moderate AD, over 24 weeks: producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp Improved cognition Showed trends toward ameliorating decline in function (ADL) and global clinical status/clinically meaningful change (CGIC) Was generally safe and well tolerated A large Phase III program in mild moderate AD is ongoing to confirm and further elucidate the beneficial effects and safety profile of idalopirdine 16 s d évaluation et de prise en charge Alz Tproduction ite.
17 MERCI producti 2014 Congrès National des Unités de soins d évaluation et de prise en charge Alz Tp s d évaluation et de prise en charge Alz Tproduction ite.
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