Analysts have suggested that an approved disease-modifying treatment for Alzheimer's could be worth more than $10 billion to the company that comes up with it. So far, the pot of gold at the end of the rainbow has been just an illusion.
To date, more than 200 testing programs focused on the physical changes in the brains of Alzheimer's patients have failed to yield a single treatment, according to FierceBiotech. Billions of dollars have been spent to unlock the mystery of Alzheimer's and to find a therapy that works against the underlying cause of the disease to no avail.
Despite the lack of success, the battle continues. That's understandable considering the critical need for an effective treatment and the financial rewards that will accrue to the company that can find one.
The size of the problem can't be overstated. In the next 20 years, cases of dementia are expected to double to 80 million worldwide. Alzheimer's is the sixth leading cause of death in the U.S. and will cost the nation more than $300 billion by 2050, according to the Alzheimer's Association.
The FierceBiotech report shows that there are nearly 90 Alzheimer's compounds in tests being conducted by members of Big Pharma, small, less-well-known biotechs and research institutions.
For many years, scientists have targeted both extracellular amyloid plaques and, more recently, intracellular tau protein tangles in the brain. Out of these efforts came one potential candidate, the amyloid drug aducanumab, which Biogen Inc. (BIIB, Financial) recently submitted to the Food And Drug Administration for approval. Getting the OK is no slam-dunk by any means because of the drug's somewhat sketchy history. Biogen and its partner, Easai Co.Ltd. (TSE:4523, Financial), stopped phase 3 testing last October because the medication simply wasn't working. Shortly afterward, Biogen changed its mind and said that additional data showed aducanumab was effective.
Despite the lack of success with amyloid-targeting drugs, this category still makes up 13 of 32 medications in late-stage clinical trials, just about the same percentage as the year prior, according to an analysis from the Us Against Alzheimer's organization.
Two of those drugs being tested are Roche's (RHHBY, Financial) gantenerumab and Eli Lilly and Co.'s (LLY, Financial) solanezumab. It was reported earlier this year that both failed to show any improvement in patients with an early-onset, inherited type of Alzheimer's.
Roche says it is still committed to gantenerumab and also has a drug similar to aducanumab that the Swiss company and its partner, AC Immune (ACIU, Financial), are still testing, even though two phase 3 trials of the treatment were halted last year.
Eli Lilly thinks a higher dose of solanezumab might be effective and tests results are expected in late 2022. The company also has a drug called donanemab, an immunotherapy that is designed to attack the main component of amalyoid plaques. Pfizer Inc. (PFE, Financial) and Johnson & Johnson (JNJ, Financial) had the first immunotherapy for Alzheimer's, but it failed safety and efficacy testing years ago.
Several private companies are also testing this type of treatment, including Spanish biotech Araclon and South Korea's AriBio. Meanwhile, Annovis Bio Inc.(ANVS, Financial) is heading into phase 2 trials with a drug the company said homes in on the "toxic cascade" that leads to neurodegeneration in Alzheimer's and other diseases like Parkinson's.
Those testing anti-tau treatments include Biogen--through licensing deals with Ionis Pharmaceuticals Inc. (IONS, Financial) and Sangamo Therapeutics Inc. (SGMO)--Roche's Genentech unit, Eli Lilly and Anavex Life Sciences Corp. (AVXL).
Disclosure: The author holds positions in Eli Lilly, Pfizer and Johnson & Johnson.
Read more here:
- Blueprint Maintains Independence, Roche Gets Competitor for Eli Lilly Drug in $775 Million Deal
- After Blow to MS Drug, Biogen Needs OK on Alzheimer's Treatment More Than Ever​
- Latest Innovent Deal Gives Eli Lilly Drug Rights Outside China
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