World Alzheimer’s Day is observed annually on Sep 21. The day is marked with countless global campaigns, raising awareness to counter the common stigma surrounding Alzheimer related dementia. The campaign was launched in 2012.

What is Alzheimer's Disease?

A type of dementia, Alzheimer’s Disease (AD) is a progressive medical condition, impairing memory and other mental functions. Its key symptoms include memory loss and loss of other essential cognitive abilities that hinder even daily activities in an individual’s life.

Majority of AD patients are aged above 65 years. However, per estimates, approximately 200,000 people below the senior citizen age bracket are suffering from the disease in the United States alone. Most people often think that this disease is normal during one’s silver years.

Drugs/Therapies Currently Approved

While there is no cure for the disease yet, there are a few drugs approved by the FDA for Alzheimer’s that help control the symptoms. A class of drugs called cholinesterase inhibitors is administered to patients in the early to moderate stages of Alzheimer’s. Among these, Exelon patch is a prescription medicine used to treat mild, moderate, and severe memory problems associated with AD. Allergan’s (AGN - Free Report) Namenda is an N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.

The AD market has attracted a lot of attention from several biggies in the pharma/biotech space, given its market potential (estimated value of the U.S. market for the disease is around $30 billion). However, successful development of therapies for treating Alzheimer’s disease is challenging due to risk of adverse events. Big shots like Merck and Pfizer had earlier terminated development of candidates for AD due to failure of studies.

Stocks in Focus

Here we take a look at companies with promising candidates in their pipeline for AD.

Swiss pharma giant Roche Holdings (RHHBY - Free Report) has two late-stage pipeline candidates, namely crenezumab and gantenerumab. Both are currently being evaluated for Alzheimer’s. The company also has an anti-tau molecule in phase II for AD. Crenezumab is currently being studied in two phase III, two-year, randomized, double-blind, placebo-controlled, multicenter clinical trials (CREAD 1 and 2) for addressing patients in early AD stage. Based on data from two phase II trials, the CREAD studies are administering higher doses of crenezumab and have enrolled patients showing initial signs of AD who have also confirmed AD pathology. The candidate is also being assessed in a landmark Alzheimer’s Prevention Initiative (API) trial involving cognitively healthy individuals in Colombia with an autosomal dominant mutation and who are at risk to develop early-onset AD. Gantenerumab is being investigated in two phase III studies (GRADUATE 1 and 2) for the treatment of early AD. Additionally, the candidate is being studied as part of the DIAN-TU trial, a worldwide clinical program, evaluating multiple compounds in individuals at risk or with a type of early-onset AD caused by a genetic mutation. Both candidates have exhibited great potential.

Roche’s stock has lost 3.2% so far this year against the industry’s increase of 6.8%. The company currently sports a Zacks Rank #1 (Strong Buy).

Biotech bigwig Biogen, Inc. (BIIB - Free Report) and partner Eisai are evaluating a number of candidates for AD. The most promising of the lot is BAN2401, an anti-amyloid beta (Aβ) protofibril antibody, currently under evaluation for the treatment of early AD. Both companies had earlier reported positive data from a phase II study on BAN2401, raising hopes for a possible remedy. Biogen has a collaboration agreement with Eisai to jointly develop and commercialize BAN2401, and E2609, a BACE inhibitor for the treatment of AD.In August 2018, both companies announced data from a phase I long-term extension study, evaluating aducanumab in patients with prodromal AD or mild AD dementia. The study included a titration Cohort wherein patients were dosed for 36 months and fixed-dose cohorts, in which patients were treated for 48 months. The results for each dose arm were generally consistent with previous interim analyses.

Shares of Biogen currently carry a Zacks Rank #3 (Hold). The stock has gained 7.1% so far this year versus the industry’s 3.5% decrease.

Pain Therapeutics, Inc. is evaluating PT-125, a proprietary small molecule drug for the treatment of AD. Last month, the National Institutes of Health (NIH) awarded the company with a $3.2-million clinical research grant to support a phase II study on PTI-125. The company plans to commence a study during the fourth quarter of 2018. Earlier this year, the company completed a phase I study. Moreover, it has a diagnostic test for AD. PTI-125DX is a simple blood test to detect or confirm whether a person has Alzheimer’s disease, even years before symptoms appear.

Year to date, shares of Pain Therapeutics have plunged 75.9% against the industry’s increase of 5%.

Conclusion

Given the unmet need in the AD space for a possible cure and the risks associated with it, a favorable development of any of these candidates will be a great boost to the concerned companies.