AlzeCure’s Alzheimer’s project receives approval to start phase I study
pharmafile | August 31, 2021 | News story | Manufacturing and Production |
AlzeCure Pharma AB, a pharmaceutical company that develops a broad portfolio of candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer’s disease and pain, announced that the company has received approval from the regulatory authorities in Sweden to begin the next clinical phase I study (multiple ascending dose, MAD) with the candidate drug ACD856 focused on Alzheimer’s disease.
The MAD Phase I study is AlzeCure’s third clinical study with ACD856, the lead candidate drug within the company’s NeuroRestore platform.
ACD856 is being developed as a symptom-relieving treatment for disease states where the cognitive ability is impaired, such as in Alzheimer’s disease. The primary study goal is to evaluate ACD856’s tolerability and safety after repeated dosing, as well as to examine early signals on brain activity.
The substances in the NeuroRestore platform stimulate several important signalling pathways in the brain, which, among other things, leads to improved cognition. Preclinical studies have shown that AlzeCure’s candidate drugs strengthen the communication between nerve cells and improve cognitive ability including memory functions.
Johan Sandin, CSO at AlzeCure Pharma, said: “I’m very pleased that we have all regulatory approvals in place to be able to start the next study with ACD856.
“This means we will be able to start the MAD study during the fall, which is in line with our previously communicated goals.”
Martin Jönsson, CEO of AlzeCure Pharma AB, said: “This is a statement of strength that shows that AlzeCure continues to deliver according to plan.
“Diseases with cognitive disorders, and especially Alzheimer’s disease, are areas with high need of new, more effective treatments and I am very much looking forward to the continued development of this important candidate drug”.