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Biogen's Alzheimer Disease Candidate Succeeds in Phase II

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Biogen Inc.’s (BIIB - Free Report) shares were up around 7% in after-market trading on Thursday on positive top-line data from a mid-stage study evaluating its pipeline candidate, BAN2401 for the treatment of early Alzheimer’s disease (AD).

Biogen is developing BAN2401, a humanized beta amyloid antibody, in collaboration with Japan’s Eisai Co., Ltd. Amyloid is a protein that forms plaques in the brains of people with Alzheimer’s. The candidate is being investigated to see whether it can slow the progression of memory problems associated with amyloid.

Top-line results of the final analysis of the phase II study (n=856) demonstrated statistically significant slowing of disease progression on the key clinical endpoint (ADCOMS) after 18 months of treatment in patients receiving the highest treatment dose (10 mg/kg biweekly) of BAN2401 as compared to placebo. Meanwhile, treatment with this high dose for 18 months also led to reduction of amyloid beta accumulated in the brain. The study included five dose regimens.

This data marked an important breakthrough by Biogen and Eisai in the challenging AD market which led to the share price increase. However, so far this year, Biogen’s shares have declined 6.2%, almost inline with the industry’s decline of 6.5% in the same time frame.

 

 

 

In late 2017, data announced from the same study failed to show early positive results, which raised investors’ concerns about the candidate’s chances of success. An Independent Data Monitoring Committee said that BAN2401 did not meet the criteria for success based on a Bayesian analysis at 12 months as the primary endpoint. With the study failing to show an early positive result, the company said that the blinded study, which is being conducted in patients with mild cognitive impairment (MCI) due to AD or mild Alzheimer's dementia (collectively known as early Alzheimer’s disease) will continue with a comprehensive final analysis to be conducted at 18 months.

Detailed data from the study is expected to be presented at future conferences.

Alzheimer’s, a fatal illness that causes progressive decline in memory, has always been a highly challenging area with not much progress being made in spite of significant investments (both funds and resources).

Several companies have failed to develop safe and effective treatment options for this deadly brain disease.

Last month, Lilly (LLY - Free Report) and its Swiss partner AstraZeneca (AZN - Free Report) discontinued two late-stage studies on their Alzheimer’s disease candidate, lanabecestat, on recommendation of the IDMC. The IDMC said that the two studies were unlikely to meet their primary goals upon completion. Back in November 2016, Lilly said that it would not seek approval for its investigational AD treatment, solanezumab, following disappointing results from a late-stage study.

In May this year, J&J (JNJ - Free Report) halted development of atabecestat, its investigational BACE inhibitor, which was being developed for preclinical stage AD due to safety concerns.

In February this year, Merck discontinued the second late-stage study evaluating its BACE inhibitor verubecestat for the treatment of prodromal AD as its success was unlikely. In February last year, Merck discontinued a late-stage study evaluating verubecestat for mild-to-moderate AD due to lack of efficacy.

In January, Pfizer said it will end R&D efforts in the Alzheimer’s and Parkinson’s disease areas. Long back, Pfizer had shelved its late-stage AD candidate, bapineuzumab IV after it failed two phase III studies.

Despite the setbacks, several companies continue to invest heavily in developing Alzheimer’s disease treatments, given the high commercial potential in this market. Success in this area means huge returns, considering that more than five million Americans are living with Alzheimer’s disease with the numbers expected to triple by 2050 (Data: Alzheimer's Association). It is considered to be one of the biggest burdens of society and is the sixth leading cause of death across all ages in the United States. The market has immense commercial potential and companies coming out with new treatments could rake in billions of dollars in sales.

Biogen currently 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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