Multiple Doses Of AlzeCure’s ACD856 Safe, Well Tolerated
Repeated dosing of ACD856, an investigational therapy for Alzheimer’s disease, was generally safe and well tolerated in healthy adult volunteers, according to data from a now-completed Phase 1 trial.
AlzeCure Pharma is developing ACD856 as its lead therapeutic candidate in the company’s NeuroRestore platform, which contains investigational therapies for diseases marked by cognitive impairments.
The third clinical study to test the medication, the multiple-ascending dose trial (NCT05077501) — initiated in September 2021 — evaluated the safety and tolerability of repetitive oral dosing of ACD856 in about 24 healthy adults enrolled at the Uppsala University Hospital in Sweden.
The therapy was rapidly taken up in the body and reached clinically relevant concentrations in the central nervous system (brain and spinal cord), pharmacokinetic analyses showed, according to AlzeCure. Pharmacokinetics refers to the movement of a compound into, through, and out of the body.
Upcoming trials focused on ACD856’s clinical effectiveness are being prepared, AlzeCure reported.
“We are very pleased that ACD856 has a very good profile for further clinical development,” Johan Sandin, PhD, AlzeCure’s chief scientific officer, said in a press release. “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.”
ACD856 is designed to enhance the signaling of neurotrophins, a family of proteins that regulate the development and maintenance of nerve cells in the brain whose normal levels are disrupted early in the course of Alzheimer’s disease.
In restoring neurotrophin signaling, ACD856 — and other therapeutics in the NeuroRestore platform — are thought to be able to enhance nerve cell communication and improve cognitive function.
Preclinical studies showed ACD856 increases levels of key brain chemicals in a brain region involved in memory processing and improved memory in rats. It’s also shown to affect various phases of memory formation and reverse age-induced cognitive impairments in mice.
A first Phase 1 clinical study evaluated the medication’s pharmacokinetics and found it suitable for further clinical development. Another Phase 1 study (NCT05077631) investigated the safety and tolerability of single-ascending doses of ACD856. Results showed single doses were well tolerated and had good bioavailability, meaning it’s able to be absorbed and used by the body.
Consistent with the previous findings, AlzeCure now reports that multiple doses of the therapy continue to be safe and well tolerated with a good pharmacokinetic profile.
“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,” Martin Jönsson, CEO of AlzeCure, said. “I also see that these data will stimulate potential partnership and out-licensing discussions and increase interest in the NeuroRestore platform.”