[ad_1]
In Japan, Zai announced to have confirmed a significant inhibition of the progression of the Phase II clinical trial (201 test) of the early treatment antibody of Alzheimer's disease "BAN2401 Which is co-developed with Biogen. The "210 test", performed by Eisai in the badysis of
is a placebo comparator, double-blind, in parallel comparison and randomization test for 856 patients with early Alzheimer's disease in which accumulation of beta-amyloid is confirmed. Ezai conducted an badysis using ADCOMS (Alxheimer's Disease Composite Score), a newly developed evaluation index. As a result, at the 18-month period, the highest dose of BAN2401 showed a statistically significant inhibition of symptom progression compared to the placebo group. At the same time, amyloid PET badysis showed that the same Maximum dose group had a decrease in amyloid accumulation. And the positive conversion of amyloid PET image diagnosis was statistically significant compared to the placebo group.
Eisai and Biogen have signed a joint development and marketing agreement for the beta-amyloid drugs of the 2014 beta, E2609 and BAN2401, that inhibit beta accumulation.
In December 2017, the 12-month badysis of & # 39; BAN2401 & # 39; revealed that the main element of the badessment was "unfulfilled"; and continued testing for final interpretation at 18 months according to protocol.
In the final interpretation of this 18-month study, the highest dose of ADCOMS, an important clinical parameter in the evaluation of pre-established statistical methods, showed a statistically significant improvement by compared to the placebo group at 12 months.
Eisai's New Roller Jig Business Group Clinical Lead and Chief Medical Officer "This is a late clinical trial on anti-amyloid antibodies, the first in the world to show a statistically improving Significant clinical symptoms and amyloid reduction We believe that the amyloid hypothesis has been verified based on the results of this clinical trial and we plan to consult with regulatory authorities in the future in order to determine the next step based on the key results "We will do our best to provide the BAN 2401 as quickly as possible to patients and medical staff."
Source link
