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Merck (MRK) Halts Another Late Stage Study on Alzheimer’s


Merck & Co., Inc. MRK announced that it is discontinuing another study evaluating verubecestat for the treatment of prodromal Alzheimer’s disease as its success was unlikely.

APECS was a phase III study evaluating the efficacy and safety of verubecestat, an oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor, versus placebo.

The study was stopped on the recommendation of an external data monitoring committee, which assessed the study’s overall benefit/risk during a recent interim safety analysis. The committee said that the chances of observing positive risk/benefit profile in the study, if it continued, were slim.

Shares of Merck declined almost 1% on Tuesday. In the past year, Merck’s shares have underperformed the industry. Merck’s shares have declined 15.8% in the period against a 10% increase for the industry.

In February last year, Merck had discontinued another study, EPOCH (phase II/III), on verubecestat, which was evaluating it for mild-to-moderate Alzheimer’s disease due to lack of efficacy. At that time, the committee had recommended that the APECS study continue unchanged.

The Alzheimer’s disease market has attracted a lot of attention from several companies. However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging and we note that several companies have failed in this regard.

Last month, Pfizer PFE reportedly said in a statement that it will end R&D efforts in the Alzheimer’s and Parkinson’s disease areas, which will result in about 300 layoffs.

Long back, Pfizer shelved its late-stage Alzheimer’s candidate, bapineuzumab IV after it failed two phase III studies.

In December 2017, Biogen BIIB announced that an Alzheimer’s disease study on BAN2401 failed to show early positive results, which raised investor concern about the candidate’s chances of success.

In November 2016, Lilly’s LLY anti-amyloid candidate solanezumab failed to meet the primary endpoint in a late-stage AD study. Lilly decided to drop the development of solanezumab. Lilly also suffered a major setback in August 2010, when it had to halt the development of another phase III Alzheimer’s candidate, semagacestat.

The Alzheimer’s disease market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.

Merck 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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