Gantenerumab is a subcutaneously-administered fully human anti-amyloid monoclonal antibody with highest affinity for aggregated amyloid-beta. Subcutaneous administration allows a flexible administration setting, with the potential to accommodate lifestyle differences and treatment access across different healthcare systems.

Throughout the gantenerumab clinical development program, subcutaneous administration was continuously evaluated and optimized. A summary of findings supporting the value and feasibility of subcutaneous administration is presented.

A summary of evidence from the gantenerumab clinical development program is reported including: a) a randomized, placebo-controlled crossover study in healthy participants to evaluate injection pain following subcutaneous administration of gantenerumab versus placebo (NCT02882009); b) assessment of feasibility of care partner-assisted at-home administration in a Phase II study in participants with early AD (NCT04592341); c) plasma concentrations and pharmacokinetic characteristics from a population pharmacokinetic model analysis.

Subcutaneous gantenerumab was locally well tolerated with predominantly mild, reversible, and self-limited injection-site reactions. Minimal to slight pain was reported (verbal-rating scale) after needle insertion with minor differences recorded for gantenerumab versus placebo. Visual analogue scale (VAS; from 0 [no pain] to 100 [worst pain possible]) least square means were 15.006 vs 9.526, respectively (mean difference 5.48; 95% CI –1.971 to 12.931). Pain was reported directly after injection and subsided within 5 minutes (VAS < 5 mm). Pharmacokinetics of subcutaneous gantenerumab was comparable across clinical studies.

The Phase II study included a home-administration questionnaire to assess confidence of care partners as drug administrators, ease of use, and convenience.