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Roche (RHHBY) AD Study Failure Puts Spotlight on BIIB & Others
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The Alzheimer’s disease (AD) study space witnessed yet another setback with Roche (RHHBY - Free Report) announcing the failure of the GRADUATE I and II studies, evaluating gantenerumab in early AD.
Gantenerumab is a fully-human monoclonal IgG1 antibody, an investigational medicine that is subcutaneously administered and designed to target and bind to aggregated forms of beta-amyloid, including oligomers, fibrils and plaques, and activate immune cells in the brain (microglia) to clear amyloid plaques and prevent further accumulation.
The studies did not meet their primary endpoint of slowing clinical decline. Patients treated with gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II of -0.31 and -0.19, respectively, from the baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB). However, neither was statistically significant.
The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with AD, was lower than expected.
The candidate was being developed in collaboration with MorphoSys (MOR - Free Report) .
Shares of Roche were down 4.58% following the news while partner MorphoSys lost 28.1%.
Shares of Roche have declined 20.2% in the year so far against the industry’s increase of 4.6%.
Image Source: Zacks Investment Research
The news also put the spotlight on other companies developing AD treatments namely Biogen (BIIB - Free Report) , Eli Lilly (LLY - Free Report) and Prothena.
Alzheimer’s is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
Shares of Biogen gained 3.32% as competitor Roche’s drug failed. Biogen and partner Eisai had earlier announced positive top-line results from the phase III confirmatory Clarity AD clinical trial of lecanemab (BAN2401), an investigational antiamyloid beta protofibril antibody for the treatment of mild cognitive impairment due to early AD with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
We remind investors that the FDA’s approval of Biogen and Eisai’s controversial AD drug, Aduhelm, in June 2021 put the spotlight on companies having promising AD candidates in their pipeline last year as well. The euphoria regarding Aduhelm, however, died down as the drug witnessed a slow launch due to reimbursement issues as its efficacy was under question.
Nevertheless, despite the complexities associated with developing a treatment for AD and past failures, the space will continue to attract attention from pharma and biotech companies, given the significant unmet need.
Lilly is evaluating donanemab, an investigational antibody that targets a modified form of beta-amyloid called N3pG for treating AD. The candidate is under priority review in the United States for AD under the accelerated approval pathway.
Prothena is evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for treating AD. Prothena is also evaluating PRX005 in collaboration with Bristol Myers. PRX005 — a potential treatment for AD — is an investigational antibody that targets tau, a protein implicated in diseases, including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction.
Image: Bigstock
Roche (RHHBY) AD Study Failure Puts Spotlight on BIIB & Others
The Alzheimer’s disease (AD) study space witnessed yet another setback with Roche (RHHBY - Free Report) announcing the failure of the GRADUATE I and II studies, evaluating gantenerumab in early AD.
Gantenerumab is a fully-human monoclonal IgG1 antibody, an investigational medicine that is subcutaneously administered and designed to target and bind to aggregated forms of beta-amyloid, including oligomers, fibrils and plaques, and activate immune cells in the brain (microglia) to clear amyloid plaques and prevent further accumulation.
The studies did not meet their primary endpoint of slowing clinical decline. Patients treated with gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II of -0.31 and -0.19, respectively, from the baseline score on the Clinical Dementia Rating-Sum of Boxes (CDR-SB). However, neither was statistically significant.
The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with AD, was lower than expected.
The candidate was being developed in collaboration with MorphoSys (MOR - Free Report) .
Shares of Roche were down 4.58% following the news while partner MorphoSys lost 28.1%.
Shares of Roche have declined 20.2% in the year so far against the industry’s increase of 4.6%.
Image Source: Zacks Investment Research
The news also put the spotlight on other companies developing AD treatments namely Biogen (BIIB - Free Report) , Eli Lilly (LLY - Free Report) and Prothena.
Alzheimer’s is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
Shares of Biogen gained 3.32% as competitor Roche’s drug failed. Biogen and partner Eisai had earlier announced positive top-line results from the phase III confirmatory Clarity AD clinical trial of lecanemab (BAN2401), an investigational antiamyloid beta protofibril antibody for the treatment of mild cognitive impairment due to early AD with confirmed presence of amyloid pathology in the brain. Lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
We remind investors that the FDA’s approval of Biogen and Eisai’s controversial AD drug, Aduhelm, in June 2021 put the spotlight on companies having promising AD candidates in their pipeline last year as well. The euphoria regarding Aduhelm, however, died down as the drug witnessed a slow launch due to reimbursement issues as its efficacy was under question.
Nevertheless, despite the complexities associated with developing a treatment for AD and past failures, the space will continue to attract attention from pharma and biotech companies, given the significant unmet need.
Lilly is evaluating donanemab, an investigational antibody that targets a modified form of beta-amyloid called N3pG for treating AD. The candidate is under priority review in the United States for AD under the accelerated approval pathway.
Prothena is evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for treating AD. Prothena is also evaluating PRX005 in collaboration with Bristol Myers. PRX005 — a potential treatment for AD — is an investigational antibody that targets tau, a protein implicated in diseases, including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction.
Roche has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.