Merck & Co., Inc. MRK announced that it is discontinuing a late-stage study evaluating its pipeline candidate, verubecestat for the treatment of mild-to-moderate Alzheimer’s disease due to lack of efficacy.
Shares of Merck declined almost 2% in after-hours trading on Tuesday. This year so far, Merck’s shares are up 11.5%, while the Zacks classified Large-Cap Pharma industry is up 2%.
EPOCH was a phase II/III study evaluating the efficacy and safetyof 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 did not observe any clinical benefit in the study.
However, the committee did recommend that the other study on verubecestat – APECS – which is a phase III study evaluating verubecestat for the treatment of prodromal Alzheimer’s disease, continue unchanged. Data from this study are expected this month.
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 developing treatments for the same.
In Nov 2016, Eli Lilly and Company LLY announced that its key Alzheimer candidate, solanezumab failed to meet the primary endpoint in a late-stage study that was conducted in patients with mild Alzheimer's dementia. With the failure, Lilly decided to drop the development of solanezumab. Solanezumab was an anti-amyloid beta monoclonal antibody, which Lilly was co-developing with TPG-Axon Capital.
Meanwhile, Pfizer PFE 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 and Elan Corporation. The Alzheimer’s disease market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
Separately, Merck announced that its pipeline candidate doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) being evaluated for the treatment of HIV-1 infection, met the primary efficacy endpoint in pivotal phase III trial. The primary efficacy endpoint was the proportion of participants achieving levels of HIV-1RNA less than 50 copies/mL after 48 weeks of treatment. Data from the study showed that doravirine was non-inferior to ritonavir-boosted darunavir in previously untreated adults after 48 weeks of treatment.
Merck 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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