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“Eisai’s broad clinical program for lecanemab continues to deliver data regarding
how lecanemab can be used as a potential disease-modifying treatment for patients
with Alzheimer’s disease. The subcutaneous dosing currently being evaluated in the
Clarity AD open-label extension study can potentially be of further benefit for
patients,” Gunilla Osswald, CEO of BioArctic, said in a press release.
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The optimal intravenous (into-the-vein, IV) lecanemab dose was found in an 18-
month Phase 2 clinical trial (NCT01767311) that examined its effectiveness, safety,
and tolerability in 854 patients.
They also investigated how body weight impacts the amount of lecanemab patients
are exposed to, the reduction in beta-amyloid plaques, and the incidence of amyloid-
related imaging abnormality-E (ARIA-E) – adverse events related to lecanemab use
that can manifest as brain edema.
They found the average concentration of lecanemab in patients’ blood was similar
after subcutaneous and IV lecanemab, but the peak blood concentration of
lecanemab was lower after subcutaneous dosing. Moreover, patients weighing less
than 57kg had higher exposure, while those weighing more than 90 kg had lower
exposure to subcutaneous lecanemab. For most individuals who weighed between
57-90 kg, exposures were comparable.
“There is a great enthusiasm in the Alzheimer field for lecanemab and the other late-
stage second-generation anti-amyloid antibodies with Phase 3 readouts in the
coming months,” Osswald said. “We are eagerly looking forward to the topline data
of the Clarity AD Phase 3 study this fall and the possibility of helping the Alzheimer
community battle the disease.”
Pending data from the Clarity AD trial, which is expected this fall, the U.S. Food and
Drug Administration is anticipated to decide about whether to approve lecanemab by
Jan. 6, 2023.