The hope for a drug that will change the course of Alzheimer's disease after decades of failure, rises again. Experimental therapy slowed mental decline by 30 percent in patients who received the highest dose in a mid-stage study and eliminated much of the sticky plaque that had stuck their brains, the drug's makers said Wednesday.
The results were highly anticipated and have shot up the share of the two companies involved in recent weeks.
Eisai's and Biogen's drug failed to reach its main target in a study of 856 participants, making it a total flop. But the company representatives said that 1
Advertising – The Story Continues Below
There are many reservations about the work, which was conducted by business researchers rather than by academic researchers and not audited by external experts. The study was also too small to be definitive and the results need to be confirmed with more work, demographic experts said. But they welcomed every success after several failures.
"We are cautiously optimistic," said Maria Carrillo, chief science officer of the Alzheimer's Association, whose international conference in Chicago presented the findings.
"A 30 percent deceleration of decay is something I want my family member to have," and the drug's ability to clear the plaques in the brain "looks pretty amazing," she said.
More than 50 million people worldwide suffer from dementia, and Alzheimer's is the most common type. There are no short-acting medications that just relieve symptoms. Some previous efforts to develop a drug to slow the disease may have been attempted too late after much damage had already occurred. The new drug targets people with early Alzheimer's disease in the past, and the drug acts on the formation of sticky plaques at an earlier stage.
Study participants received one of five doses of BAN2401 or a dummy treatment over IV. After one year, the companies said the drug did not meet the statistical targets. But after 18 months, they saw a benefit in the highest dose group.
However, what makes it difficult is that they used a new way to measure mental decline, a scale that combines parts of three other widely used tests. This is the first study that uses this measure, and it's unclear how much of a 30 percent difference makes the decay slow – whether it allows someone to continue bathing or feeding themselves.
"It's fascinating, but these are designs that we're not accustomed to seeing," and it requires more study for physicians to feel comfortable with that as a measure of success, said an independent expert. Julie Schneider from Rush University Medical Center in Chicago.
In a traditional measure of thinking skills, those with the highest dose were 47 percent less likely than people who received a dummy treatment.
Brain scans supplemented evidence that the drug could be effective. All participants had signs of the sticky plaques that are the hallmark of Alzheimer's disease at the beginning of the study, but 81 percent of the people with the highest dose dropped all signs after 18 months, an Eisai official said.
Adverse drug discontinuation occurred in 19 percent of high-dose patients and 6 percent in bogus treatment. Cases of brain swelling seen in other treatments targeting plaques in the brain occurred in two people in the placebo group and in 16 in the high dose group.
Other dementia experts were encouraged.
That's a very hopeful result. It means we're on the right track, "said Dr. Stephen Salloway, a neurologist at Brown University in Providence, Rhode Island.
Dr. Reisa Sperling, a neurologist at Harvard-affiliated Brigham and Women's Hospital in Boston, said it was important to realize that this was not a cure, but possibly a deceleration of decay.
"We do not suddenly bring people back to Alzheimer's baseline," she said.
Dr Lynn Kramer, Chief Medical Officer of Eisai's Neurology Department, said companies would talk to regulators about further studies.
Biogen's shares, based in Cambridge, Massachusetts, and Eisai, based in Tokyo, rose after the 5th In July, the drug had slowed the progression of early Alzheimer's disease for certain patients.The Biogen share rose 19.6 percent in one day, the largest increase in 14 years, and is still gesti Eisai shot up 40 percent in two days.
The Biogen share was traded after the publication of the study results in aftermarket trading. After several changes between profits and losses, he fell by 6.5 percent.