AlzeCure Pharma has completed the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, with a focus on Alzheimer’s disease.
Data show that ACD856, the primary drug candidate within the company’s NeuroRestore platform, has good tolerability and safety. Furthermore, the results demonstrate that the substance has suitable pharmacokinetic properties with rapid uptake into the body as well as relevant and dose-dependent exposure in the CNS, states the company.
“We are very pleased that ACD856 has a very good profile for further clinical development,” says Johan Sandin, CSO at AlzeCure Pharma. “With its potential to improve memory function in a variety of diseases, ACD856 may play a significant role in the treatment of indications where these key functions are impaired, such as Alzheimer’s disease, sleep apnea, traumatic brain injury and Parkinson’s disease.”
The MAD Phase I study
The MAD Phase I study is AlzeCure’s third clinical study with ACD856, the company’s leading drug candidate in the NeuroRestore platform. The substance is being developed as a symptom-relieving treatment for disease states where cognitive ability is impaired, for example in Alzheimer’s disease. The primary objective of the study was to evaluate the tolerability, safety and pharmacokinetics of the drug candidate after repeated dosing.
The company started the study in September 2021 and is now presenting according to plan results from this clinical study with ACD856. Preparations are now being made to initiate further clinical trials. These upcoming studies are focused on evaluating early effect-signals in humans.
“The results for the NeuroRestore candidate ACD856 follow the previous positive clinical results with the substance, and we are now looking forward to the continued clinical studies,” says Martin Jönsson, CEO of AlzeCure. “I also see that these data will stimulate potential partnership and out-licensing discussions and increase interest in the NeuroRestore platform.”
Photo of Martin Jönsson and Johan Sandin, AlzeCure: Jenny Lagerqvist