New data on lecanemab presented at the CTAD Alzheimer conference
STOCKHOLM, Nov. 15, 2021 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) and partner Eisai held several oral presentations at the 14th Clinical Trials on Alzheimer's Disease (CTAD) conference, November 9-12, 2021, revealing new data on lecanemab (BAN2401), an investigational anti-amyloid beta protofibril antibody. The presentations provided further support for the encouraging data regarding lecanemab's potential as a treatment for early Alzheimer's disease previously seen in the Phase 2b as well as open label extension study. In addition, data presented showed the potential to use blood tests with p-tau181 and Aβ42/40 to monitor treatment effect of lecanemab. Data presented also clarified similarities and differences in the binding profiles of lecanemab compared to other late-stage anti-amyloid antibodies for Alzheimer's disease.
In a presentation by Professor Lars Lannfelt, co-founder of BioArctic, the binding profiles to different amyloid-beta species of lecanemab, aducanumab and gantenerumab, the three most developed antibodies for Alzheimer's disease were compared. All three investigated antibodies were found to mainly bind aggregated forms of amyloid beta, with low binding strength to monomers. The data further identified lecanemab as a strong amyloid-beta binder with the highest selectivity for the aggregated soluble forms of amyloid-beta, called oligomers and protofibrils, believed to be the most neurotoxic.
In a late-breaking roundtable presentation by Eisai, new data from the open label extension study (OLE) of the Phase 2b study of lecanemab, in patients with early Alzheimer's disease, gave further support to the encouraging results seen in the Phase 2b study as well as previous OLE data. The presentation highlighted the rapid reduction of brain amyloid seen in PET scans as early as after three months of treatment and the profound amyloid clearance with more than 80% of patients being amyloid negative after 12 months treatment in the OLE. Clinical treatment difference between the highest dose of lecanemab and placebo was maintained after discontinued dosing over an average 24-month period between the core and OLE study, suggesting potential disease modifying effect. No titration is required for lecanemab, and the treatment was well tolerated. Lecanemab remains associated with a low incidence of the side-effect ARIA-E, below 10%, and with a symptomatic ARIA-E rate of less than 2% in both the Core and OLE study. In addition, data presented showed the potential to use blood tests with p-tau181 and the Aβ42/40 ratio to monitor treatment effect of lecanemab. Amyloid reduction measured by PET and blood Aβ42/40 data suggested a correlation with slower decline the clinical endpoint ADCOMS at population as well as individual levels in the core phase. Eisai stated that monitoring treatment effect using such blood tests may be used for simple dose modification (e.g. less frequent and/or lower dose).
Eisai also presented a new analysis of the robustness of the lecanemab efficacy results from the Phase 2b study in 856 early Alzheimer patients, showing that the clinical efficacy results are consistent across endpoints and multiple statistical methods. Consistent treatment effect was observed after 18 months treatment with lecanemab 10mg/kg biweekly for all three clinical scales; ADCOMS, CDR-SB, and ADAS-Cog, with separation from placebo observed by six months for the top dose (10mg/kg biweekly) across all analyses.
Baseline characteristics from the pivotal Clarity AD study in 1,795 patients with early Alzheimer's disease, building on the encouraging findings from the lecanemab Phase 2b study, were presented showing that they are consistent with the Phase 2b study and representative of an early Alzheimer's disease population. Clarity AD study is designed to confirm clinical efficacy, safety, and pharmacodynamic properties of lecanemab 10 mg/kg biweekly versus placebo in subjects with early Alzheimer's disease and Eisai expects that the topline data will be available by end of September 2022.
Also on the Clarity AD study, a presentation outlining the stepwise tier-based approach in the screening process for the study showed how this approach could reduce trial burden on clinical sites, patients and study partners. This could allow for sites to focus their resources and attention on potentially qualified patients for the trials.
The blood test with Aβ42/40 ratio was also the focus in another talk outlining how this blood biomarker is now being used in screening of subjects for the Phase 3 AHEAD 3-45 study. 1,400 subjects at risk for developing Alzheimer's disease will be included in the study with the aim to evaluate the efficacy of lecanemab in pre-symptomatic subjects with elevated levels of amyloid in the brain. The plasma Aβ42/40 ratio demonstrated very good ability to predict amyloid PET levels and determine eligibility for the AHEAD 3-45 study. Plasma screening could thus have a potential to substantially reduce the number of PET scans needed to fully enroll the study saving both time and money. Also, if ongoing trials aiming to prevent cognitive decline in pre-symptomatic Alzheimer's disease are successful, plasma screening measures may be critical to identify individuals most likely to benefit from early intervention.
"The great presentations by Lars Lannfelt and our partner Eisai on lecanemab and the progress in the broad ongoing clinical trial program, gives deeper insight into the uniqueness of lecanemab and its potential to help patients with early Alzheimer's disease. We are looking forward to the continued development of this potentially disease-modifying treatment," said BioArctic's CEO Gunilla Osswald.
BioArctic and Eisai's presentations on lecanemab from the CTAD congress are available on www.bioarctic.com.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
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Oskar Bosson, VP Communications and IR
The information was released for public disclosure, through the agency of the contact persons above, on November 15, 2021, at 08:00 a.m. CET.
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