Anavex's Blarcamesine Shows Sustained Benefits for Alzheimer's Treatment Over Four-Year Period.

Anavex Life Sciences presented encouraging results from its research on blarcamesine, an oral compound for early Alzheimer's disease treatment. The findings demonstrate sustained benefits for patients over four years, with improved cognition and function in the intent-to-treat analysis and the GWAS-defined population ABCLEAR2. Anavex's focus on precision medicine and CNS disorders positions it well in a niche market with high unmet needs. The company's financial health is strong, with a current ratio of 6.74 and no debt.

A significant development in the treatment of early Alzheimer's disease (AD) was presented at the Alzheimer's Association International Conference (AAIC) 2025. Eisai Co., Ltd. and Biogen Inc. announced that results on investigational maintenance therapy with subcutaneous autoinjector (SC-AI) of lecanemab-irmb (U.S. brand name: LEQEMBI®) demonstrated comparable efficacy and safety to the intravenous (IV) formulation [1].

Lecanemab, an anti-amyloid beta (Aβ) protofibril antibody, targets both protofibrils and plaque, which can impact tau accumulation downstream. The new SC-AI formulation offers a potential new treatment option for patients with early AD, their care partners, and healthcare professionals. The clinical trials of lecanemab SC were conducted as a sub-study of the open-label extension (OLE) following the core Phase 3 Clarity AD study in individuals with early AD [1].

The pharmacology, clinical, and biomarker relationships established with extensive clinical data supported the FDA approval of IV maintenance therapy after the initial 18 months of treatment and support the investigational SC maintenance dose option. Data shows that transitioning to a weekly 360 mg SC AI dose of lecanemab after 18 months of initiation dose (10 mg/kg IV biweekly) maintains clinical and biomarker benefits comparable to continued biweekly IV dosing [1].

The safety profile of 360 mg weekly SC maintenance dosing was shown to be consistent with that of IV maintenance therapy, with 1% systemic injection/infusion reactions. Across all SC doses, the rate of systemic injection/infusion reactions is 1% compared to 26% with IV. The 360 mg SC maintenance dose was initiated after 18 months of IV treatment, beyond the high-risk period for ARIA. There were 0 cases of ARIA-E observed out of 49 treated with 360 mg SC weekly maintenance for a mean of 6 months [1].

Study participants successfully administered SC-AI and found it easy to use. Over 95% of participants reported that the SC-AI is easy to administer and were highly satisfied with it. These studies and evaluations of lecanemab SC-AI have demonstrated that the investigational SC-AI offers efficacy and safety comparable to IV administration with the potential to reduce the incidence of infusion site adverse events [1].

The SC formulation has the potential to reduce medical preparation and administration time related to IV therapy. These factors suggest that the SC AI may play an important role in continuing treatment for early AD. Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority [1].

References:
[1] https://www.biospace.com/new-data-presented-at-aaic-demonstrates-investigational-leqembi-lecanemab-irmb-360-mg-subcutaneous-maintenance-dosing-could-offer-a-new-option-for-ongoing-treatment-of-early-alzheimers-disease