Last patient has completed AlzeCure's Phase Ib clinical study with NeuroRestore ACD856

AlzeCure Pharma AB, a biotech company that develops candidate drugs for diseases affecting the nervous system, focusing on Alzheimer's disease and pain, today announced that the last patient’s last visit (LPLV) has now occurred in the ongoing Phase Ib clinical trial of ACD856, the lead drug candidate within the NeuroRestore platform, which is being developed for Alzheimer’s disease and other indications.

Previous preclinical and clinical results for ACD856 have demonstrated a very strong safety and tolerability profile, enabling a wide potential therapeutic window. To capitalize on this potential, we initiated these supplementary clinical studies to further increase human dosing, which may also be relevant for other indications such as depression.” Johan Sandin, CSO, AlzeCure Pharma

The Phase Ib clinical study aims to evaluate the safety and tolerability of ACD856 following repeated administration of higher doses, while also assessing the substance's concentration in the body. AlzeCure has previously obtained key data showing that ACD856 crosses the blood-brain barrier in relevant concentrations and activates pathways vital for both cognition and depression. These findings support the further development of the drug candidate as an oral treatment for Alzheimer’s disease and other indications.

Preclinical studies have previously shown that AlzeCure’s drug candidates within the NeuroRestore platform strengthen communication between neurons and improve cognitive performance, including learning and memory functions. Previous preclinical results from AlzeCure also demonstrate neuroprotective, anti-inflammatory, and disease-modifying effects in various models using these so-called Trk-PAM substances, which enhance BDNF and NGF signaling.

The unique pharmacological mechanism of NeuroRestore also enables its use across several different indications, such as Alzheimer’s and Parkinson’s disease, as well as depression. ACD856 is a first-in-class drug candidate for Alzheimer’s disease and is currently being prepared for upcoming Phase II clinical trials. Furthermore, it was awarded a major EU grant from the European Innovation Council (EIC) in 2025.

“The fact that the study has proceeded according to plan is excellent news. We see that a wide therapeutic window further strengthens the commercial potential for this promising substance, including in other areas with high unmet medical needs, such as depression," said Martin Jönsson, CEO of AlzeCure Pharma.