After completing Phase II of clinical trials, Biogen and Eisai’s new candidate drug for Alzheimer’s Disease is showing strong potential in a field where research has met relentless challenges and a series of drug candidates have been unsuccessful. Indeed, the failure rate for Alzheimer’s drugs has been 99.6 percent over the past decade.
My dream is that our industry will be able to offer a drug treatment for what is the number one worry in many countries
Michel Vounatsos, Biogen
With Pfizer joining a slew of other Big Pharma players in quitting Alzheimer’s and Parkinson’s research earlier this year in favour of focusing on cancer and cardiology treatments, the future for these chronic and neurodegenerative diseases looked bleak. There are currently no treatments on the market which slow the progression of Alzheimer’s. The drugs currently being prescribed to patients can offer some symptomatic relief from dementia, but do not slow, stop or reverse the disease progression.
However, US biotech Biogen – in partnership with the Japanese firm Eisai – has bucked that trend and announced positive results in the Phase II trials of their Alzheimer’s candidate drug BAN2401. The drug has shown a statistically significant slowing of the disease in patients who received the highest dose over 18 months compared to those treated with a placebo; although some patients did develop brain swelling due to the treatment. Biogen’s uncontested leadership position in the segment has prompted Globes’ Gali Weinreb to call the company, “The only current hope for Alzheimer’s Disease.”
BAN2401 targets beta-amyloid – a protein which forms toxic plaque between neurons in the brain and is thought to be the cause for the gradual neurodegeneration associated with Alzheimer’s. BAN2401 works similarly to the late-stage treatment, aducanumab, which is also being tested by Biogen and is currently in Phase III trials.
Enthused by this development, Michel Vounatsos, Biogen’s CEO stated, “My dream is that our industry will be able to offer a drug treatment for what is the number one worry in many countries. Every patient has three carers carrying him on their back. It’s both an economic and a social burden. My dream is that the pharmaceutical formulation and technology will provide a combined solution for the Alzheimer’s Disease patient.”
Researchers have calculated the impact of BAN2401 based on a new measure called Alzheimer’s Disease Composite Score (ADCOMS). Most Alzheimer’s treatments are evaluated by a different metric known as Clinical Dementia Rating — Sum of Boxes (CDR-SB). There is a debate on whether ADCOMS is a sufficient measure for Alzheimer’s treatments, however, Piper Jaffray analyst Christopher Raymond does not expect much regulatory opposition against trials that use ADCOMS measurement as their primary goal. The FDA has recently displayed increasing flexibility on using alternative goals in Alzheimer’s treatment studies.
Biogen is scheduled to release more specific details about the impact of BAN2401 on July 25, however, the company has not elaborated on what information will be released. According to analysts, the US FDA requires a 15 percent improvement of Alzheimer’s treatment over placebos to gain approval. Despite the requirements, researchers are cautiously optimistic about the final Phase III trial for BAN2401, the end results of which are expected in late 2019 or early 2020.
“Bottom line, we think anywhere between 15 to 20 percent placebo-adjusted treatment effect should be considered a win,” says Raymond – even seeing 25 percent as very possible.