AlzeCure Pharma AB (publ) announced that another scientific article has been published on the phase I clinical results supporting the continued development of the lead drug candidate NeuroRestore ACD856. The article, titled ACD856, a Novel Positive Allosteric Modulator of Trk-receptors, Single Ascending Doses in Healthy Subjects: Safety and Pharmacokinetics, was published in the European Journal of Clinical Pharmacology and the responsible author is Märta Segerdahl, MD, PhD and CMO at AlzeCure Pharma. Co-authors are Boel Nilsson, Johan Bylund, Magnus Halldin, Matthias Rother, Erik Rein-Hedin and Kristin Önnestam.

AlzeCure has previously published positive data from the subsequent clinical phase I MAD study. The article focuses on the results from the clinical phase I study (Single Ascending Dose, SAD) with ACD856, the primary drug candidate within the company's NeuroRestore platform, but also contains data from the previously performed microdose study in humans. The results of this study, which was the first clinical study of ACD856, demonstrated that the compound had suitable pharmacokinetic properties with a half-life in humans that allows for once-daily dosing.

The subsequent SAD study was able to confirm the good pharmacokinetic properties with rapid absorption in the body and a linear increase in the concentration of the substance in the blood with increased oral dosage. Furthermore, it was observed that the substance has good tolerability and safety in humans. 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 potential protective and disease-modifying effects.