Alzinova (ALZ) Study Result summary

Study design and objectives

• Phase 1b study evaluated safety, tolerability, and immune response of ALZ-101 in early Alzheimer's disease patients.

• Study included 26 patients, with different dose strengths (125, 250, 400 µg) and placebo.

• Extension part (part B) offered all patients 250 µg ALZ-101 for 20 weeks, followed by 48 weeks of observation.

• Part A2 with 400 µg ALZ-101 is ongoing, with final data expected in Q1 2025.

Key results and findings

• ALZ-101 showed a favorable safety and tolerability profile after at least 84 weeks.

• Over 95% of patients developed a robust, long-lasting immune response.

• Exploratory endpoints indicated a positive, dose-dependent trend in cognitive and functional outcomes.

• Asymptomatic ARIA events were observed in both treated and placebo groups.

• Side effects included local injection site reactions and asymptomatic ARIA-E and ARIA-H on MRI.

Implications and next steps

• Results support further clinical development and preparations for a phase 2 study are ongoing.

• Additional biomarker data from the extension part are expected in Q1 2025.

• Company aims to accelerate partnership discussions to advance ALZ-101.

• ALZ-101 targets toxic amyloid-beta oligomers, potentially offering advantages over existing therapies.