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09-Aug-2023

AlzeCure publishes the positive clinical results from the phase I trial of NeuroRestore ACD856 against Alzheimer's

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 a new scientific article has been published on the Phase I clinical results supporting the continued development of the lead candidate drug NeuroRestore ACD856.

The article, titled Safety, Tolerability, Pharmacokinetics and Quantitative Electroencephalography Assessment of ACD856, a Novel Positive Allosteric Modulator of Trk-Receptors Following Multiple Doses in Healthy Subjects, was published in The Journal of Prevention of Alzheimer's Disease and the corresponding author is Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Kristin Önnestam, Boel Nilsson, Matthias Rother, Erik Rein-Hedin, Johan Bylund, Peter Anderer, Manuel Kemethofer, Magnus Halldin and Johan Sandin.

The article focuses on the results from the clinical phase I study (Multiple Ascending Dose, MAD) which shows that ACD856, the primary drug candidate within the company's NeuroRestore platform, has good tolerability and safety. Furthermore, it was observed that the substance has suitable pharmacokinetic properties with rapid absorption in the body and relevant and dose-dependent exposure in the CNS. In addition, AC856 was shown to increase EEG activity in the brain, indicating that the substance reaches and activates regions of the brain that are central for cognitive-enhancing and antidepressive therapies.

"The results presented in the article show that ACD856 has a very good profile for further clinical development. With its potential to improve memory functions in a variety of diseases, ACD856 may have a significant role in the treatment of indications where these key functions are impaired, such as Alzheimer's disease, traumatic brain injury and Parkinson's disease," said Märta Segerdahl, CMO at AlzeCure Pharma.

ACD856 is a Trk-PAM and enhances BDNF and NGF signaling, which play an important role in normal neuronal function. The substance is under development as a symptom-relieving treatment for medical conditions where the cognitive ability is impaired, for example in Alzheimer's disease. New preclinical data also suggest that ACD856 has potentially protective and disease-modifying effects.

“The clinical phase I data we have obtained with ACD856 are very promising and the need for new drugs in the Alzheimer's field is great. The results with the substance which support treatment to improve learning and memory abilities as well as depression are clearly positive with regard to partnership and out-licensing discussions and increases interest in the NeuroRestore platform," said Martin Jönsson, CEO of AlzeCure Pharma.

The article is available via the following link: https://rdcu.be/dijyU

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Last Updated: 09-Aug-2023