dm+d

Unassigned

New Medicines

Early Alzheimer's disease (MCI and mild)

Information

New molecular entity
Biogen & Eisai
Biogen & Eisai

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
May 22Eisai has completed filing to US FDA and has requested priority review, which if granted, will deliver a response from FDA in 6 months time. Full approval is expected to be submitted by Q2 23 with ongoing PIII Clarity AD trial as confirmatory study [16].
Jan 22Lecanemab is considered by analysts to have blockbuster potential [14].
Sep 21Eisai initiates rolling submission to US FDA for Biologics License Application of lecanemab for early Alzheimer´s disease under the accelerated approval pathway. The BLA is primarily based on data from the PIIb trial (Study 201) in people with early AD and confirmed amyloid pathology. [12]
Jun 21Granted breakthrough therapy designation in US [10]
Aug 18Will be filed in the EU using the centralised procedure [2].

Category

Humanised immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that selectively binds and clear protofibrils, large highly-toxic soluble aggregates of beta-amyloid that have been implicated in the development of Alzheimers Disease.
Alzheimers disease is the most common form of dementia, accounting for around 50% of cases. It is estimated to affect 496,000 people in the UK [1].
Early Alzheimer's disease (MCI and mild)
Intravenous infusion

Trial or other data

Jun 21PIII Clarity AD now expects to complete collecting primary outcome data in Sep 22 [11].
Oct 20PIII Clarity AD study (NCT03887455) is recruiting & expects to complete collection of primary outcome data in Jun 22 [9].
Jul 19PIII Clarity AD study (NCT03887455) is recruiting & expects to complete collection of primary outcome data in Feb 22 [8].
Mar 19 PIII trial (Clarity AD/Study 301) has started recruiting 1,566 patients with mild congitive impairment, or mild Alzheimer´s disease dementia, with amyloid accumulation. The international, double-blind trial compares BAN2401 10mg/kg twice monthly to placebo. The primary end-point is change from baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) (a cognition and function scale) at 18 months. Changes to two further clinical scale [AD composite score (ADCOMS) and AD Assessment Scale-Cognitive Subscale (ADAS-cog) will be key secondary outcomes. Brain amyloid levels, measured using amyloid PET, will also be a secondary outcome. Final data expected in 2022 [6,7].
Mar 19Final primary outcome data from trial Clarity AD/Study 301 expected in 2022 [7]. Final primary outcome data from trial Clarity AD/Study 301 expected in 2022 [7].
Oct 18Eisai plans an open-label extension (OLE) trial of the PII Study 201 trial (NCT01767311) in 2018 [5].
Jul 18PII study (NCT1767311) completes [4].
Jul 18Biogen and BioArctic report that BAN 2401 significantly cleared amyloid plaque and reduced clinical decline in early AD patients. Results from the trial were presented at the Alzheimers Association International Conference 2018 (AAIC-2018). Eisai and Biogen are discussing the further development of BAN 2401 with regulatory authorities [5].
Dec 12 PII study (NCT01767311) starts. Using a Bayesian design with response adaptive randomization across placebo or 5 active arms of BAN2401, the study aims to determine clinical efficacy and to explore the dose response of BAN2401 using a composite clinical score (ADCOMS). It is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to AD or mild AD dementia. Frequent interim analyses will be conducted to continually update randomisation allocation on the basis of the primary clinical endpoint. In the event of early success in the Core Study at any interim analysis (IA) or at the Bayesian analysis at 12 months of treatment, an open label extension (OLE) Phase will be implemented to allow for up to 60 months (5 years) of additional treatment. The OLE will not be conducted if early success is not achieved at any IA or at the Bayesian analysis at 12 months of treatment. 856 patients will be recruited globally including US & EU (plus UK). Collection of primary outcome data due to complete Jul 18 [3].

Evidence based evaluations

Pre-clinical Alzheimer's disease

Information

Licence extension / variation
Biogen & Eisai
Biogen & Eisai

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Humanised immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that selectively binds and clear protofibrils, large highly-toxic soluble aggregates of beta-amyloid that have been implicated in the development of Alzheimers Disease.
Alzheimers disease is the most common form of dementia, accounting for around 50% of cases. It is estimated to affect 496,000 people in the UK [1].
Pre-clinical Alzheimer's disease
Intravenous infusion