Significantly alleviates cognitive decline! Eisai / Bo Jian AD new drug reached the clinical endpoint of phase 3

On September 28, 2022, Eisai and Biogen jointly announced that lecanemab, an investigational therapy for Alzheimer's disease (AD), reached the primary endpoint in the Phase III clinical trial Clarity AD in the treatment of patients with mild Alzheimer's disease and mild cognitive impairment (MCI) caused by Alzheimer's disease, significantly improving patients' CDR-SB scores, and the trial reached all key secondary endpoints
.
Eisai will present the findings
at the Alzheimer's Disease Clinical Trials Conference on November 29.

Lecanemab is an anti-β amyloid (Aβ) fibril antibody used to treat patients with
confirmed amyloid lesions in the brain, mild cognitive impairment (MCI) and mild AD (collectively referred to as early AD) due to Alzheimer's disease (AD).

Eisai completed the BLA submission in early May 2022, and on July 6, Eisai and Biogen jointly announced that the U.
S.
FDA has accepted Lecanemab's Biologics Licensing Application (BLA
).

Lecanemab's biologics license application is based on Lecanemab's clinical, biomarker and safety data from the proof-of-concept Phase IIb clinical trial, the Open Label Extended Study, and the unblinded safety data
of ongoing Phase III clinical trials.
Data from previous Phase IIb clinical trials showed that lecanemab reduced amyloid plaque levels in the
brain.
The results of the phase III clinical trial showed that at 6 months of treatment, the lecanemab group showed a statistically significant difference from the placebo group, and all key secondary endpoints also had a statistically significant improvement (p<0.
01), which is undoubtedly a major positive news
.

Eisai announced its resolution to restructure its global structure from its previous business group structure to a new R&B, Deep Human Biology Learning
.
A few days later, Eisai decided to permanently close its oncology department, H3 Biomedicine, with an expected layoff of 88
.
According to FierceBiotech, work in the oncology division will continue in
the DHBL division.

On July 15, 2022, Eisai announced a new organizational structure, DHBL (Deep Human Biology Learning), which is scheduled to be launched
on October 1, 2022.
Previously, the Neurology Group, Oncology Group, Drug Development Center, and HC Data Creation Center will be dissolved
.
The closure of H3 Biomedicine is part of
that huge plan.

Eisai said that Alzheimer's disease and related brain disease modification therapy (DMT) related research and development, supervision, medical treatment, value, access, marketing and alliance management functions, of which the next generation of Alzheimer's disease treatment drug lecanemab, is its most important project
.
As early as 1996, Eisai launched the classic treatment drug of Alzheimer's disease Doneprazine hydrochloride, and joined hands with the two giants of Pfizer and Johnson & Johnson to make the drug an "explosive product"
.
For decades thereafter, Eisai has been betting heavily on CNS drug development
.

More than twenty years after the introduction of donepezi, Eisai launched Aduhelm last year to treat early-stage Alzheimer's disease
.
However, Aduhelm's approval was controversial and did not achieve the expected sales
.
Fortunately, the storm in Aduhelm did not affect the determination of Eisai and Bojian to
cooperate in the development of lecanemab.

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