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Biogen's Alzheimer's Drug Misses Goal in Interim Analysis
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Shares of Biogen Inc. (BIIB - Free Report) declined by almost 3.3% after the company’s Alzheimer's candidate, BAN2401, failed to meet the criteria for success based on a 12-months interim analysis as the primary endpoint in a mid-stage trial. The company is developing the candidate in collaboration with Eisai Co., Ltd.
So far this year, shares of Biogen have gained 13.7% compared with the industry’s growth of 3%.
The phase II study (Study 201) involves 856 patients with prodromal or mild Alzheimer's disease and positive biomarkers for brain amyloid pathology. The study uses Bayesian Adaptive Randomization Design which allows automatic changes to the design during the study. For early success, Study 201 will explore efficacy and the dose response of BAN2401 with 16 interim analyses, a 12-month evaluation based on Eisai's in-house developed Alzheimer’s disease Composite Score (ADCOMS) and an 18-month comprehensive assessment of treatment with placebo or 5 active arms. The Bayesian analysis at 12 months indicated that "success was judged as an 80% or higher probability of achieving" at least a 25% reduction in the rate of decline of ADCOMS versus placebo.
The 16 interim analyses assessed potential for futility or stopping for safety. Neither of these conditions was met and the study continues to a full analysis at 18 months.
Biogen stated that the 18-month blinded study will continue further analysis, following the predefined study protocol. A comprehensive final analysis will be conducted at 18 months looking to demonstrate clinically significant results. Data from the study are expected in the second half of 2018.
Biogen is looking to strengthen its AD and other neurodegenerative disorders pipeline. Notably, the company’s Alzheimer's disease (AD) pipeline comprises candidates with different mechanisms of action including anti-tau candidate (BIIB092/BMS-986168-with potential in AD as well as progressive supranuclear palsy (PSP)), anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program.
However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging and we note that several companies have failed in developing treatments for the same. In November 2016, Eli Lilly & Company's (LLY - Free Report) anti-amyloid candidate — solanezumab failed to meet the primary endpoint in a late-stage AD study. Consequently, Lilly decided to drop the development of the candidate.
Meanwhile, Pfizer (PFE - Free Report) shelved its late-stage Alzheimer’s candidate, bapineuzumab IV, after it failed two phase III studies. Pfizer was developing the candidate in collaboration with Johnson & Johnson (JNJ - Free Report) and Elan Corporation.
The Alzheimer’s disease market represents a huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Biogen's Alzheimer's Drug Misses Goal in Interim Analysis
Shares of Biogen Inc. (BIIB - Free Report) declined by almost 3.3% after the company’s Alzheimer's candidate, BAN2401, failed to meet the criteria for success based on a 12-months interim analysis as the primary endpoint in a mid-stage trial. The company is developing the candidate in collaboration with Eisai Co., Ltd.
So far this year, shares of Biogen have gained 13.7% compared with the industry’s growth of 3%.
The phase II study (Study 201) involves 856 patients with prodromal or mild Alzheimer's disease and positive biomarkers for brain amyloid pathology. The study uses Bayesian Adaptive Randomization Design which allows automatic changes to the design during the study. For early success, Study 201 will explore efficacy and the dose response of BAN2401 with 16 interim analyses, a 12-month evaluation based on Eisai's in-house developed Alzheimer’s disease Composite Score (ADCOMS) and an 18-month comprehensive assessment of treatment with placebo or 5 active arms. The Bayesian analysis at 12 months indicated that "success was judged as an 80% or higher probability of achieving" at least a 25% reduction in the rate of decline of ADCOMS versus placebo.
The 16 interim analyses assessed potential for futility or stopping for safety. Neither of these conditions was met and the study continues to a full analysis at 18 months.
Biogen stated that the 18-month blinded study will continue further analysis, following the predefined study protocol. A comprehensive final analysis will be conducted at 18 months looking to demonstrate clinically significant results. Data from the study are expected in the second half of 2018.
Biogen is looking to strengthen its AD and other neurodegenerative disorders pipeline. Notably, the company’s Alzheimer's disease (AD) pipeline comprises candidates with different mechanisms of action including anti-tau candidate (BIIB092/BMS-986168-with potential in AD as well as progressive supranuclear palsy (PSP)), anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program.
However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging and we note that several companies have failed in developing treatments for the same. In November 2016, Eli Lilly & Company's (LLY - Free Report) anti-amyloid candidate — solanezumab failed to meet the primary endpoint in a late-stage AD study. Consequently, Lilly decided to drop the development of the candidate.
Meanwhile, Pfizer (PFE - Free Report) shelved its late-stage Alzheimer’s candidate, bapineuzumab IV, after it failed two phase III studies. Pfizer was developing the candidate in collaboration with Johnson & Johnson (JNJ - Free Report) and Elan Corporation.
The Alzheimer’s disease market represents a huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
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Biogen carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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