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's presentation at the Alzheimer's conference AAIC 2022, regarding new clinical data with its leading drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease, is now available in its entirety on the company's website.
The presentation, titled Results From a Multiple Ascending Dose Study in Healthy Volunteers of ACD856, a Positive Modulator of Neurotrophin Trk-Receptors, was held by project manager Kristin Önnestam and contains new clinical data from the phase I MAD study with the leading drug candidate in the NeuroRestore project, ACD856. The study, in which ACD856 or placebo was administered orally repeatedly for one week to 24 healthy subjects divided into 3 groups in incremental doses, had the primary aim of evaluating the safety, tolerability and pharmacokinetics of ACD856 after repeated dosing in humans.
The results show that ACD856 has a very good tolerability and safety profile without any significant safety findings in the study participants at the tested doses of 10, 30 and 90 mg. The substance also showed a good pharmacokinetic profile with high bioavailability and a clear exposure in cerebrospinal fluid which shows that the substance crosses the blood-brain barrier in highly relevant concentrations. ACD856, which is a positive modulator of both NGF/TrkA- and BDNF/TrkB-mediated signaling, has in previous preclinical studies been shown to improve cognition and memory ability and is developed primarily for the treatment of Alzheimer's disease.
"ACD856 follows the positive development that we have observed in previous clinical studies, with a very good safety profile. We have now also been able to verify that we see a dose-dependent increase in the substance in cerebrospinal fluid, which is very important as the brain is our target organ, and these results bode well for future effect studies," said Kristin Önnestam, project leader for ACD856.
"These positive data further strengthen the continued clinical development of ACD856, which is based on a new mechanism of action with great potential for symptom relief and memory-enhancing effects in diseases with cognitive impairment, such as Alzheimer's," said Martin Jönsson, CEO of AlzeCure Pharma AB.
The abstract is written by Kristin Önnestam, Dr. Johan Sandin, CSO at AlzeCure, Dr. Matthias Rother, Medical Program Director, and Dr. Märta Segerdahl, CMO at AlzeCure.
The abstract and the poster are available on AlzeCure's website (https://www.alzecurepharma.se/en/presentations-and-interviews/).
