Alzheimer's Research Stumbles Again: What's the Road Ahead?

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)

On Tuesday, Lilly LLY and its Swiss partner AstraZeneca AZN said they are discontinuing two late-stage studies on their Alzheimer’s disease candidate, lanabecestat, on recommendation of the independent data monitoring committee (IDMC). The IDMC said that the two studies were unlikely to meet their primary goals upon completion. This prompted the decision of stalling the studies on the oral beta secretase cleaving enzyme (BACE) inhibitor.

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

In May this year, J&J JNJ 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 MRK 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 PFE 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.

In late 2017, Biogen’s BIIB AD study on BAN2401 failed to show early positive results, which raised investors’ concerns about the candidate’s chances of success.

Clinical-stage biopharmaceutical company Axovant Sciences suffered a major setback in September 2017 when its investigational AD candidate failed to meet the co-primary efficacy endpoints in a late-stage study. The company decided to discontinue development of the 35 mg dose for the treatment of AD.

Lilly decided in November 2016 that it would not seek approval for 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.

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.

This may be somewhat because the underlying causes of severe neurological ailments like Alzheimer’s may not be as clear as diseases like cancer. Also, Alzheimer’s progress may go unnoticed for years.  By the time, the symptoms of the ailment become evident, significant functions may be already lost, which makes developing drugs to treat this disease difficult.

Interest Still Alive in the Area

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 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, Novartis NVS, Eisai, AstraZeneca and Amgen are presently working on Alzheimer’s disease treatments.

Biogen’s AD pipeline comprises mid as well as late-stage candidates with different mechanisms of action including anti-tau candidate (BIIB092), anti-amyloid (aducanumab) candidates as well as a BACE inhibitor (elenbecestat) program. These candidates are being developed in collaboration with Eisai.  

Meanwhile, Novartis and Amgen are collaborating for BACE 1 inhibitor, CNP520, which has fast track status in the United Status. Roche is collaborating with AC Immune for the development of Alzheimer’s disease treatments.

Lilly and AstraZeneca are also developing another treatment for Alzheimer's disease, an antibody targeting beta amyloid in early-stage studies.

Earlier this year, the FDA proposed new guidelines, which are aimed at lowering the clinical study goals of Alzheimer’s disease drugs aimed to treat earlier-stage patients who have not yet displayed functional disability or clinical abnormality. This strategy is part of FDA’s ongoing efforts to expand access to safe and effective treatment options for many serious conditions. These efforts by the FDA may also reinvigorate research efforts for Alzheimer’s drugs after repeated failures.

Lilly and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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