Factbox: Roche's drug failure extends long list of Alzheimer's trial setbacks

H Lundbeck A/S

14/11/2022 13:45

(Rewrites first paragraph with Roche trial failure, adds Roche
to table)
       Nov 14 (Reuters) - Roche Holding AG  ROG.S  reported on
Monday that its Alzheimer's drug candidate, gantenerumab, did
not meet main goals of studies, marking another setback for
companies trying to find an effective treatment for the
memory-robbing disease.
    The results come nearly two months after partners Eisai Co
Ltd  4523.T  and Biogen Inc  BIIB.O  reported that their
Alzheimer's disease drug, lecanemab, significantly slowed
cognitive decline in a large trial. 
    The following is a list of high-profile Alzheimer's disease
trial failures: 
 Company     Drug           Trial outcome     Mechanism of
 name/year                                    action
 Roche       gantenerumab               Did   Designed to
  ROG.S                     not meet main     target
 (2022)                     goals of trials,  beta-amyloid
                            failed to slow    and remove
                            dementia          brain  plaques
                            progression in    to slow down
                            two studies.      dementia
                                              progression.
 Roche       crenezumab     Although small    A monoclonal
  ROG.S                     numerical         antibody
 (2022)                     differences       targeting toxic
                            favored           protein plaque
                            crenezumab, the   in the brain
                            results were not  known as beta
                            statistically     amyloid to slow
                            significant and   disease
                            potentially due   progression.
                            to chance.        
 Biogen      gosuranemab                      An antibody
  BIIB.O                    Failed to meet    directed
 (2021)                                  any  against "tau"
                            efficacy goals    proteins
                            in trial.         believed to
                                              play a role in
                                              Alzheimer's.
 Roche       semorinemab                      Targeted "tau"
  ROG.S                     Failed            proteins. 
 and AC                                  to   
 Immune                     slow cognitive    
  ACIU.O                    and functional    
 (2020)                     decline in        
                            trial.            
 Roche       gantenerumab,  Combination       Designed to
  ROG.S      solanezumab    failed to arrest  neutralize
 and Eli                    cognitive         beta-amyloid
 Lilly                      decline in those  plaques.
  LLY.N                      afflicted by     
 (2020)                     gene mutations.   
 Neurotrope  bryostatin-1   Drug did not      Designed to
 Inc, now                   show any          induce growth
 called                     significant       of synapses in
 Synaptogen                 difference in     the brain and
 ix Inc                     patients after    prevent cell
  SNPX.O                    13 weeks in a     death.
 (2019)                     mid-stage trial.  
                                              
 Biogen      elenbecestat   The companies     BACE inhibitor
  BIIB.O                    scrapped two      
 and Eisai                  late-stage        
 Co                         studies in        
  4523.T                    patients with     
 (2019)                     early             
                            Alzheimer’s,      
                            after             
                            independent       
                            committee         
                            recommended       
                            discontinuation.  
 Novartis    CNP520         Companies         BACE inhibitor
  NOVN.S ,                  discontinued two  
 Amgen                      mid-to-late-stag  
  AMGN.O ,                  e studies after   
 Banner                     identifying       
 Alzheimer'                 worsening of      
 s                          some measures of  
 Institute                  cognitive         
 (2019)                     function in       
                            treatment         
                            groups.           
 Merck & Co  verubecestat               Did   A beta
   MRK.N                    not work in       secretase
                            late-stage        cleaving enzyme
  (2018)                    trials in         (BACE)
                            patients with     inhibitor,
                            both very early   which aims to
                            Alzheimer's and   prevent amyloid
                            those with mild-  buildup. 
                            to-moderate       
                            Alzheimer's.      
 AstraZenec  lanabecestat   Companies         Beta secretase
 a  AZN.L ,                 discontinued      cleaving enzyme
 Eli Lilly                  late-stage        (BACE)
  LLY.N                     trials of the     inhibitor,
 (2018)                     drug after        which aims to
                            independent       prevent amyloid
                            committee         buildup.
                            concluded they    
                            were unlikely to  
                            succeed.          
 Johnson &   atabecestat                      BACE inhibitor 
 Johnson                    Stopped           
  JNJ.N                     development in    
                            mid-stage trials  
  (2018)                    after             
                            participants      
                            showed serious    
                            elevations of     
                            liver enzymes.    
 Eli Lilly   solanezumab    In a late-stage   Targets
 and Co                     study, patients   beta-amyloid,
  LLY.N                     treated with      the Alzheimer’s
 (2016)                     solanezumab did   protein that
                            not experience a  forms sticky
                            significantly     plaques in the
                            greater slowing   brain.
                            in cognitive      
                            decline vs        
                            placebo.          
 Pfizer Inc  bapineuzumab   The drugmakers    Beta-amyloid
  PFE.N ,                   called off        targeting
 Johnson &                  additional work   monoclonal
 Johnson                    after the drug    antibody.
  JNJ.N                     failed to help    
 (2012)                     patients with     
                            mild-to-moderate  
                            Alzheimer's in    
                            its second round  
                            of clinical       
                            trials.           
    <^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^
Alzheimer's drug succeeds in slowing cognitive decline, makers
Eisai and Biogen say     urn:newsml:reuters.com:*:nL1N30Y2XV
    ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^>
 (Reporting by Bhanvi Satija, Raghav Mahobe and Manas Mishra in
Bengaluru; Editing by Bill Berkrot and Sriraj Kalluvila)
 ((Manas.Mishra@thomsonreuters.com;
www.twitter.com/Manaswrites15;))