AlzeCure’s Alzheimer’s project NeuroRestore ACD856 shows positive effect on brain activity in clinical trial

AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops a broad portfolio of small molecule candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, today announced that the company has received new data from the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, which is being developed against Alzheimer's disease and other indications with cognitive dysfunction.

New data from a planned exploratory analysis of the MAD study show that ACD856 increases EEG activity in the brain. A clear difference can be seen after vs. prior to administration of the substance. This result combined with previously reported data show that the substance not only crosses the blood-brain barrier, but also reaches and activates neural pathways in the brain, with the potential of having positive effects on cognition.

The MAD phase I study is AlzeCure's third clinical study with ACD856, the company's leading drug candidate within the NeuroRestore platform. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease. The primary study objective was to evaluate the drug candidate's tolerability and safety after repeated dosing. As previously reported, ACD856 shows good safety and tolerability in both the SAD and MAD studies.

ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems and signaling substances in the brain such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition, something that has been demonstrated in previous preclinical studies. New preclinical results also show potential neuroprotective and disease-modifying effects with these substances. The biological mechanism behind NeuroRestore enables several indications, such as Alzheimer's and Parkinson's disease, but also traumatic brain injury and depression.

"These new data are very promising and show that the substance reaches and activates neural pathways in the brain, whose normal function is disrupted in diseases such as Alzheimer's," said Johan Sandin, CSO at AlzeCure Pharma.

"These are very good news that add to the previous positive data for ACD856 and further strengthens our commercial opportunities for this promising substance," said Martin Jönsson, CEO.