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How Biogen Al Sandrock's chief physician feels-after the curtain has been lifted on the clinical trial data of the experimental drug Alzheimer's that his company is developing with Japanese "That was a shot of fire in the arm for me, "he says of the trial results, which showed that BAN-2401 removed amyloid plaques from the brains of people in the early stages of Alzheimer's disease and reduced cognitive decline to him, he supports the idea that targeting amyloid can help people with Alzheimer's disease, by repeating the experiment Biogen ran with his own aducanumab, an experimental drug targeting the amyloid, and obtained the same results
I see these patients and I feel completely helpless, the idea that we are now approaching the possibility of getting the first disease modifying treatment is a gro Do not worry about me, "he says. excited when I saw the BAN data. "
Sandrock feels good, but not all observers see the data positively, and important questions remain to be explored for further data badysis and future testing.
One of the first questions posed after the presentation of data at the International Alzheimer's Conference was the decision of a health authority (not the US Food and Drug Administration) that patients with the same conditions as patients with Alzheimer's disease. a variant of the APOE gene linked to the early onset of Alzheimer's disease can not be randomized to the highest dose group, 10 mg / kg every two weeks, so that this dose group seems better than what it should. "We argued vehemently, and the results suggest that we could have been right," said Lynn Kramer, medical and clinical director of Eisai, who presented the data
This revelation was a "curve", writes Umer Raffat, an badyst at EvercoreISI. a debriefing note to clients, and on Biogen's webcast for badysts, he called it the biggest question on the lawsuit. In further badysis, he argues that he does not condemn the results of the test to be an artifact of the highest dose arm to get patients in better health. Sandrock said more badysis of the trial data to understand that would come out soon.
Brian Skorney, an badyst at R.W. Baird, is more skeptical. "The noise in this study is deafening," he wrote in a research note. "We do not think this study provides good evidence for aducanumab."
"I think there are a lot of caveats with these data, and over-interpreting and over-typing them is a mistake for our field," said Reisa Sperling. Alzheimer Research and Treatment Center at Brigham Hospital and Women & # 39; s. "But for me it's proof that we're on the right track, really very encouraging."
If the slowing down of cognition and function BAN-2401 seemed to confer in the trial is difficult to say because doctors do "I have a lot of experience with the main badessment of The test used, says Sperling, and it depends on what stage of the patient's Alzheimer's is.For people with mild dementia, the 30% reduction in the study's decline is "important but not good enough. "Earlier, when many BAN-2401 trial patients were, this effect seemed better:" If you could give people three or five years of independence, it's a huge deal. "
Question BAN-2401 It remains to be seen, but the CEO of Eisai USA, Ivan Cheung, is" optimistic, "he said at a news conference. interview before the presentation of the data. "We will be very proactive with the FDA and the other health authorities to find the best way for BAN-2401", he said, "Any innovation must become a real medicine for patients."
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How Biogen's Chief Medical Officer, Al Sandrock, Feels After Curtain on Clinical Data of the experimental drug Alzheimer developed by his company? with the Japanese drug maker Eisai?
"It was a badlash for me," he says of the test results, which show that BAN-2401 has eliminated amyloid plaques from the brain of people with early stage Alzheimer's disease . For him, he supports the idea that targeting amyloid can help people with Alzheimer's disease, by repeating the experience that Biogen has conducted with its own aducanumab, a experimental drug targeting amyloids and obtaining the same results
used to seeing these patients and feeling completely helpless, the idea that we are now approaching the possibility of obtaining the first modifying treatment of the Illness is a big problem for me, "he says. "That's why I was so excited when I saw the BAN data."
Sandrock feels good. But not all observers see the data positively, and important questions remain to be explored for further data badysis and future testing.
One of the first questions posed after the presentation of data at the International Alzheimer's Conference was the decision of a health authority (not the US Food and Drug Administration) that patients with HIV / AIDS A variant of the APOE gene related to the early onset of Alzheimer's disease can not be randomized to the highest dose group, 10 mg / kg every two weeks; fact that this dose group seems better than what it should. "We argued vehemently, and the results suggest that we could have been right," said Lynn Kramer, medical and clinical director of Eisai, who presented the data
This revelation was a "curve", wrote Umer Raffat, badyst at EvercoreISI. a debriefing note to clients, and on Biogen's webcast for badysts, he called it the biggest question on the lawsuit. In further badysis, he argues that he does not condemn the results of the test to be an artifact of the highest dose arm to get patients in better health. Sandrock said more badysis of the trial data to understand that would come out soon.
Brian Skorney, an badyst at R.W. Baird, is more skeptical. "The noise in this study is deafening," he wrote in a research note. "We do not think this study provides good evidence for aducanumab."
"I think there are a lot of caveats with these data, and over-interpreting and over-typing them is a mistake for our field," said Reisa Sperling. Alzheimer Research and Treatment Center at Brigham Hospital and Women & # 39; s. "But for me it's proof that we're on the right track, really very encouraging."
If the slowing down of cognition and function BAN-2401 seemed to confer in the trial is difficult to say because doctors do "I have a lot of experience with the main badessment of The test used, says Sperling, and it depends on what stage of the patient's Alzheimer's is.For people with mild dementia, the 30% reduction in the study's decline is "important but not good enough. "Earlier, when many BAN-2401 trial patients were, this effect seemed better:" If you could give people three or five years of independence, it's a huge deal. "
Question BAN-2401 It remains to be seen, but the CEO of Eisai USA, Ivan Cheung, is" optimistic, "he said at a news conference. interview before the presentation of the data. "We will be very proactive with the FDA and the other health authorities to find the best way for BAN-2401", he said, "any innovation must become a real medicine in the hands of patients."
