AlzeCure Pharma AB, a biotechnology company developing drug candidates for diseases affecting the nervous system, with a focus on Alzheimer’s disease and pain, announced today that the last patient visit (LPLV) has now taken place in the ongoing Phase Ib clinical trial of ACD856, the lead drug candidate in the NeuroRestore platform developed for diseases and other diseases.
Previous preclinical and clinical results for ACD856 have shown a very strong safety and tolerability profile, allowing for a wide therapeutic window. To capitalize on this potential, we initiated these additional clinical studies to further increase the human dose, which may also be associated with other indications, such as depression.”
Johan Sandin, CSO, AlzeCure Pharma
The Phase Ib clinical study aims to evaluate the safety and tolerability of ACD856 after repeated administration of higher doses, while also evaluating the concentration of the substance in the body. AlzeCure previously obtained baseline data showing that ACD856 crosses the blood-brain barrier at relevant concentrations and activates pathways critical to both cognition and depression. These findings support 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 enhance 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-PAMs, which enhance BDNF and NGF signaling.
NeuroRestore’s unique pharmacological mechanism also allows it to be used in many different indications, including 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. In addition, it has been awarded a major EU grant from the European Innovation Council (EIC) in 2025.
“The fact that the study proceeded as planned is extremely novel. We see a broad therapeutic window further enhancing the commercial potential of this promising compound, including in other areas of high unmet medical need, such as depression.” said Martin Jönsson, CEO of AlzeCure Pharma.
