Cumulative effects of idalopirdine, a 5-HT 6 antagonist in advanced development for the treatment of mild and moderate Alzheimer s disease

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1 Cumulativ ffct of idalopirdin, a 5-HT 6 antagonit in advancd dvlopmnt for th tratmnt of mild and modrat Alzhimr dia Congrè National d unité d oin, d évaluation t d pri n charg Alzhimr (USPLAZ) productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp décmbr 215, Iy-l-Moulinaux Nli BONEVA, MD, PhD ICR Nurology Lundbck d évaluation t d pri n charg Alz Tproductrdit.

2 Background A 24-wk, doubl-blind, placbo-controlld Pha II clinical trial dmontratd a pro-cognitiv ffct of idalopirdin, a adjunct to donpzil, in patint with modrat AD dmntia (MMSE 12 19) 1 With upportiv trnd in th functional and global clinical domain 1 Thi wa bad on an MMRM analyi of chang from balin in fficacy amnt, th primary ndpoint bing dfind at 24 1 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp AUC analyi of th individual clinical domain and vral clinical domain compoit to a cumulativ ffct of tratmnt ovr a 24-wk priod 2 AD=Alzhimr dia; AUC=ara undr th curv; MMRM=mixd modl for rpatd maur; MMSE=Mini Mntal Stat Evaluation 2 d évaluation t d pri n charg Alz Tproductrdit. 1. Wilkinon t al. Lanct Nurology 214;13(11): ; 2. Atri t al. J Prv Alzhimr Di 215;2(4):325

3 Mthod AUC analy for cognition (ADAS-Cog), function (ADCS-ADL 23 ), and global clinical tatu (ADCS-CGIC) wr computd by applying th trapzoidal rul to th timatd viit-wi man from th chang-cor MMRM ud in th analyi in th publihd tudy 1,2 Two compoit maur wr alo valuatd: 1,3 A 2-domain (2D) compoit coniting of qual wighting of ADAS-Cog and ADCS-ADL A 3-domain (3D) qually-wightd compoit that alo includd th ADCS-CGIC productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Cumulativ tratmnt ffct in th diffrnt domain and compoit wr compard to rult from th publihd tudy 1,3 ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; ADCS-CGIC=Alzhimr Dia Cooprativ Study Clinical Global Imprion of Chang; ADCS-ADL 23 =Alzhimr Dia Cooprativ Study Activiti of Daily Living, 23-itm cal; MMRM=mixd modl for rpatd maur; NPI=Nuropychiatric Invntory 3 1. Atri t al. J Prv Alzhimr Di 215;2(4):325; 2. Wilkinon t al. Lanct Nurology 214;13(11): ; 3. Atri t al. Potr at CTAD 215 d évaluation t d pri n charg Alz Tproductrdit.

4 Chang from balin Cumulativ ffct on ADAS-Cog p=.46-2 p=.41 p=.13 p= Improvmnt Dtrioration ADAS-Cog chang from balin Diffrnc in cumulativ AUC of ADAS-Cog (LSM ± SEM) chang from balin (man, 95% CI) productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Idalopirdin Placbo Diffrnc in AUC ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; AUC=ara undr th curv; LSM=lat quar man; CI=confidnc intrval; SEM=tandard rror of th man 4 Atri t al. Potr at CTAD p=.41 p=.54 d évaluation t d pri n charg Alz Tproductrdit.

5 Chang from balin Cumulativ ffct on ADCS-ADL Dtrioration ADCS-ADL 23 chang from balin Diffrnc in cumulativ AUC of ADCS-ADL 23 (LSM ± SEM) chang from balin (man, 95% CI) p=.92 p=.24 p=.12 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Idalopirdin Placbo Diffrnc in AUC ADCS-ADL 23 =Alzhimr Dia Cooprativ Study Activiti of Daily Living, 23-itm cal; AUC=ara undr th curv; LSM=lat quar man; CI=confidnc intrval; SEM=tandard rror of th man 5 Atri t al. Potr at CTAD p=.92 p=.55 p=.21 d évaluation t d pri n charg Alz Tproductrdit.

6 Chang from balin Cumulativ ffct on ADCS-CGIC Dtrioration p=.97 ADCS-CGIC (cntrd) Diffrnc in cumulativ AUC of ADCS-CGIC (LSM ± SEM) (cntrd) (man, 95% CI) p=.2 p=.12 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Idalopirdin Placbo ADCS-CGIC=Alzhimr Dia Cooprativ Study Clinical Global Imprion of Chang; AUC=ara undr th curv; LSM=lat quar man; CI=confidnc intrval; SEM=tandard rror of th man Atri t al. Potr at CTAD Diffrnc in AUC p=.97 p=.16 p=.33 d évaluation t d pri n charg Alz Tproductrdit.

7 Chang from balin Cumulativ ffct on ADAS-Cog/ADCS-ADL 2D-compoit Dtrioration 2D-compoit chang from balin (LSM ± SEM) p=.64 p=.21 p=.6 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Idalopirdin Placbo ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; ADCS-ADL=Alzhimr Dia Cooprativ Study Activiti of Daily Living; AUC=ara undr th curv; LSM=lat quar man; CI=confidnc intrval; SEM=tandard rror of th man 7 Atri t al. Potr at CTAD 215 Diffrnc in AUC Diffrnc in cumulativ AUC of 2D-compoit chang from balin (man, 95% CI) p=.64 p=.1 p=.91 d évaluation t d pri n charg Alz Tproductrdit.

8 Chang from balin Cumulativ ffct on ADAS-Cog/ADCS-ADL/ADCS-CGIC 3D-compoit Dtrioration 3D-compoit chang from balin (LSM ± SEM) p=.75 p=.12 p=.14 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Idalopirdin Placbo ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; ADCS-ADL=Alzhimr Dia Cooprativ Study Activiti of Daily Living; ADCS-CGIC=Alzhimr Dia Cooprativ Study Clinical Global Imprion of Chang; AUC=ara undr th curv; LSM=lat quar man; CI=confidnc intrval; SEM=tandard rror of th man Atri t al. Potr at CTAD Diffrnc in AUC Diffrnc in cumulativ AUC of 3D-compoit chang from balin (man, 95% CI) p=.75 p=.8 p=.66 d évaluation t d pri n charg Alz Tproductrdit.

9 Concluion AUC analy of 24-wk rpon profil howd robut and progrivly accumulating ffct of idalopirdin tratmnt, a adjunct to donpzil, compard with donpzil placbo tratmnt ffct 1 For th global clinical valuation, th cumulativ 24-wk idalopirdin tratmnt ffct wa ignificant for th ADCS-CGIC AUC analyi; thi had not bn prviouly obrvd with th traditional chang-cor analyi 1,2 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Th ffct on th 2D-compoit (ADAS-Cog and ADCS-ADL) wr conitnt with th ffct on ADCS-CGIC and on th 3D-compoit (ADAS-Cog, ADCS-ADL, ADCS-CGIC) 3 AUC ingl- and compoit-domain analy providd complmntary and additional information to traditional chang-cor analy 1,3 ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; ADCS-ADL=Alzhimr Dia Cooprativ Study Activiti of Daily Living; ADCS-CGIC=Alzhimr Dia Cooprativ Study Clinical Global Imprion of Chang; AUC=ara undr th curv; 9 1. Atri t al. J Prv Alzhimr Di 215;2(4):325; 2. Wilkinon t al. Lanct Nurology 214;13(11): ; 3. Atri t al. Potr at CTAD 215 d évaluation t d pri n charg Alz Tproductrdit.

10 ou zh d év al n io ua t d i pr n A Pha III fficacy and afty clinical trial programm of th lctiv 5-HT6 antagonit, idalopirdin, in mild and modrat Alzhimr dia i progring a plannd t rg ch a r, m zh i Al To u t oi dr -T ou n d êm m té l r nt ti. d t t di n tio va lu a d é l n rti pa o i t ni U tio uc ro d ld na at io r p N t è gr on C é rv ré 15 2 i pr n ch a rg im Al zh r,t ou dr o it ré r vé -T ou t r i m m r 1 êm pr r, o 5 d u p ou ct ar C i on ti dr ll gr oi è t r é Na t i na tio la rv na é l l ut zh -T i r m o io n ct Idalopirdin Pha III programm 1

11 Pha III programm Lundbck & Otuka Clinical dvlopmnt plan (ongoing trial) Tratmnt population: mild to modrat AD (MMSE 12 22) Study 14861A RCT STARSHINE 14862A RCT STARBEAM 14863A RCT STARBRIGHT 14861B Opn-labl xtnion a Do/ comparator 3 mg/day 6 mg/day Placbo 1 mg/day 3 mg/day Placbo 6 (3) mg/day Placbo Background tratmnt a Extnion of 14861A and 14862A ADAS-Cog=Alzhimr Dia Amnt Scal Cognitiv ubcal; ADCS-ADL 23 =Alzhimr Dia Cooprativ Study Activiti of Daily Living, 23-itm cal; ADCS-CGIC=Alzhimr Dia Cooprativ Study Clinical Global Imprion of Chang; RCT=randomid controlld trial 11 Tratmnt duration Total population Donpzil 24 wk 93 (31/ arm) Donpzil 24 wk 84 (28/ arm) productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp Donpzil, rivatigmin, galantamin 24 wk 72 (36/ arm) Ky fficacy ndpoint ADAS-Cog, ADCS-ADL 23, ADCS-CGIC ADAS-Cog, ADCS-ADL 23, ADCS-CGIC ADAS-Cog, ADCS-ADL 23, ADCS-CGIC 6 (3) mg/day Donpzil 28 wk Up to 1,77 ADAS-Cog, ADCS-ADL 23, ADCS-CGIC d évaluation t d pri n charg Alz Tproductrdit. ClinicalTrial.gov; Study idntifir: NCT26641; NCT ; NCT26654

12 productio 215 Congrè National d Unité d oin d évaluation t d pri n charg Alz Tp MERCI POUR VOTRE ATTENTION d évaluation t d pri n charg Alz Tproductrdit.

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