According to a recent article in Biospace, Eisai Pharmaceutical and Biogen Biotechnology recently announced updates to their Phase IIB study 201 and a five-year open-label extension (OLE) studies using lecanemab for the treatment of early Alzheimer’s disease.
Visual PET readings showed that treatment with lecanemab resulted in the reduction of brain amyloid levels within three months. These findings were followed by a substantial 80% clearance at 12 to 18 months.
Updates were presented at the 2021 Clinical Trials for Alzheimer’s Disease conference in early November. The conference was held online and live in Boston. The findings reflected biomarker and safety analyses of the reduction of brain amyloid while using lecanemab.
In 2017 both companies, Biogen and Eisai, entered into an agreement for the joint development of lecanemab. Since their Phase II trial showed promising results, the companies decided to begin a Phase III study for patients with early AD.
Further, a group of individuals considered to be normal clinically but with raised amyloid levels have been enrolled in a Phase III study which began in July 2020.
About Amyloid Plaque
The amyloid protein associated with Alzheimer’s has several molecular forms that are situated among neurons. In the brain of a person with Alzheimer’s, these abnormal proteins clump together forming plaque. The proteins accumulate between the neurons and interrupt cell functions. Research on this subject is ongoing.
A recent assessment was consistent with the earlier trials where several were open-label extensions (OLE). The term OLE is used when describing a study where both the participant and the researcher know what treatment the patient is receiving. An OLE is useful when comparing treatments or gathering information.
The treatment consisted of 10 mg/kg of lecanemab infusion bi-weekly, then a gap of nine to fifty-nine months with no treatment.
Patients who continued to receive lecanemab for eighteen months were tested along with those patients who had no treatment for up to fifty-nine months. Two new biomarkers (blood tests) were available to analyze treatment effects together with PET.
Cognition decline was somewhat slower in subjects receiving lecanemab than in the control group. The end result was that the difference was minimal (0.10). Participants who continued treatment showed results slightly above those in the control group.
The researchers suggest that these findings confirm the full extent of amyloid reduction through the use of lecanemab. The findings are currently being verified through the 5-year Phase 3 Clarity AD study with an enrollment of 1795 participants.
FDA Accelerated Approval Program
The FDA’s accelerated approval program is an opportunity for early approval of drugs that qualify as treating serious conditions and fulfilling an unmet need. Eisai has begun its application to the FDA for a Biologics License via accelerated approval.