Eisai and Biogen to move into late Stage Clinical Trials for Alzheimer’s Drug

Earlier in the month, Eisai Co. (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) announced that their large clinical trial of the Alzheimer’s drug, BAN2401, slowed the progression of Alzheimer’s at its highest dosage. The Companies will be proceeding to late-stage clinical trials of BAN2401 with regulators to design future studies and pursue accelerated approvals. “We are certainly considering ‘prime’ status in Europe, ‘breakthrough’ in the United States and ‘sakigake’ in Japan,” said Dr. Lynn Kramer, Chief Medical Officer of Eisai’s neurology unit.

In interviews with Reuters, Eisai said the treatment also worked at lower doses. Kramer said the Companies plan to start more trials. More information will be made public at the Alzheimer’s Association International conference in Chicago.

The Companies, in the successful trial earlier in the month, said that patients who received the highest dose of BAN2401 saw significant improvement. In an earlier statement from Biogen, “Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months.” The positive results were a surprise as the Alzheimer’s drug failed when tested at the primary endpoint of 12 months.

Alzheimer’s is the most common form of dementia and currently affects an estimated 50 Million people around the world. This number is expected to more than double, rising to 131 Million by 2050, according to Alzheimer’s Disease International.

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