The company has received approval to be able to give additional doses of ACD856 in their clinical phase I study (single ascending dose, SAD) with ACD856, as its good tolerability enables higher doses to be tested.

Data from the SAD study establish that ACD856, the lead candidate drug within the company’s NeuroRestore platform, shows good tolerability with a half-life consistent with the half-life in the first clinical study with the substance. The results demonstrate that ACD856 is suitable for further clinical development as oral treatment for, among others, Alzheimer’s disease.

Potentially a large therapeutic window

The study also shows that the bioavailability is very good, which, in combination with the good tolerability in the preclinical toxicological studies, indicates that ACD856 potentially has a large therapeutic window.

The positive clinical findings obtained and additional preclinical data have prompted AlzeCure to apply for a further increase in dose in the clinical trials, which has now been granted by the regulatory authority. The subsequent clinical study (multiple ascending dose, MAD) with ACD856, where repeated dosing will be evaluated, is expected to start according to plan, and as previously communicated, during the second half of 2021.

“We are very pleased with the good tolerability and bioavailability that ACD856 has shown. The possibility of increasing the dose is very important and will significantly strengthen the clinical development program for the candidate drug,” says Johan Sandin, CSO at AlzeCure Pharma. “With its potential to improve memory functions in a number of different diseases, ACD856 may play a significant role in the treatment of indications where these key functions are impaired, such as Alzheimer’s disease, sleep disorders, traumatic brain injury and Parkinson’s disease.”

Photo of Johan Sandin: AlzeCure Pharma