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Alzheimer's Market Suffers Yet Another Blow with Merck Drug Setback

Merck & Co., Inc.MRK suffered a pipeline setback with its investigational Alzheimer's disease treatment, verubecestat, being halted in a phase II/III study. The EPOCH study was stopped after an interim analysis by an external Data Monitoring Committee (eDMC) indicated that the study might fail.

While the EPOCH study has been stopped due to lack of efficacy, another study, APECS, will continue as the eDMC noted that the safety signals observed in the other study were not enough to stop APECS.

Verubecestat is an enzyme beta-site amyloid precursor protein cleaving enzyme 1 (BACE1) inhibitor. Inhibiting the actions of the BACE enzyme may help stop the formation of amyloid plaque deposits in the brain which may be the underlying cause of Alzheimer's disease. While the EPOCH study was being conducted for mild-to-moderate Alzheimer's disease (AD), the APECS study is for people with prodromal Alzheimer's disease. Results from the APECS study are expected in Feb 2019.

Despite the disappointing news, the impact on Merck's shares was negligible with shares slipping 0.8%. So far this year, Merck has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 10.7% compared to the industry gain of 5.3%. Merck is a Zacks Rank #3 (Hold) stock -- you can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Yet Another Blow for Alzheimer's Disease Research

Merck's news represents the latest setback in the pharma and biotech sector's quest to find a treatment for Alzheimer's. Just a few months back in November, Eli Lilly and Company LLY had announced the discontinuation of its investigational AD treatment, solanezumab, following disappointing results from a late-stage study. The candidate was being evaluated to see whether it can slow the progression of memory problems associated with amyloid, a protein that forms plaques in the brains of people with Alzheimer's.

How Will Other Alzheimer's Disease Stocks Fare?

With Merck and Lilly facing setbacks in this field, the question that is foremost on the mind of investors and the medical community is will other companies involved in this area face a similar fate? Some of the companies working on Alzheimer's disease treatments include names like Biogen Inc. BIIB , Novartis AG NVS , AstraZeneca plc AZN , Eisai, Amgen Inc. AMGN , and Axovant.

In fact, aducanumab is one of the most important candidates in Biogen's pipeline. Aducanumab, which is currently in phase III development, is an amyloid beta antibody like solanezumab but the drugs have fundamentally different mechanisms of action. Aducanumab's mechanism of action is more direct with the drug targeting aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients.

Moreover, the patient population is slightly different. Biogen is studying the prodromal and early mild population while solanezumab was investigated in the mild patient population. In fact, many experts feel that these two factors -- a direct mechanism of action and a more appropriate patient population -- could work in Biogen's favor.

Biogen has also partnered with Eisai for elenbecestat (E2609), a BACE inhibitor currently in a phase III program and BAN2401, a humanized beta amyloid antibody in phase II development.

AstraZeneca and Lilly are collaborating for the development of AZD3293, a BACE inhibitor in a couple of pivotal studies, and MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is in early stage studies as a potential disease-modifying treatment for Alzheimer's.

Axovant's intepirdine is in phase III development for patients with mild-to-moderate Alzheimer's disease with topline results expected in the third quarter of 2017. Intepirdine is a 5-HT6 receptor antagonist.

Novartis and partner Amgen's BACE inhibitor CNP520 received Fast Track designation in the U.S. Phase III studies have commenced in all pre-Alzheimer's disease populations. According to Novartis, it is the only company to move into the preclinical Alzheimer's disease space while most of the companies involved in Alzheimer's disease research are focused on mild to moderate severe disease or prodromal AD with or without plaque showing up on MRI.

Roche and AC Immune are working on crenezumab, an anti-Abeta antibody. Crenezumab is also in phase III development in patients with prodromal or mild Alzheimer's disease with data readout expected in 2020.

Bottom-Line

The key takeaway from Merck's update is that Alzheimer's is a difficult-to-treat ailment. It has historically been a very challenging therapeutic area with quite a few stocks stumbling in their efforts to find a treatment. Apart from Merck and Lilly, companies like Johnson & Johnson JNJ , Pfizer, and Lundbeck among others have also had their share of setbacks in this field.

However, with the market being highly lucrative, several companies continue to invest heavily in developing Alzheimer's disease treatments. According to the Alzheimer's Association, in the 10 years from 2002-2012, 244 drugs were tested for Alzheimer's in studies registered with clinicaltrials.gov out of which only one succeeded and went on to gain FDA approval.

While these numbers are far from encouraging, success in this area means huge returns considering an estimated 5.4 million Americans of all ages had Alzheimer's disease in 2016 (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 U.S. The market has immense commercial potential and companies coming out with new treatments could rake in billions of dollars in sales.

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Astrazeneca PLC (AZN): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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