AlzeCure Pharma AB (publ) (FN STO: ALZCUR), a pharmaceutical company that develops small molecule drug candidates for CNS diseases, focusing on Alzheimer’s disease and pain, today 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.
“The clinical results from the phase I studies with ACD856 show that the substance has a very suitable profile for continued clinical development. The previously published clinical phase I MAD results with the substance show that the substance also reaches the brain and can activate neural pathways with relevance for both memory and learning, as well as depression,” 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 potential protective and disease-modifying effects.
“The results for NeuroRestore ACD856 are promising, and the need for new drugs in the field is very great. The substance has the potential to improve learning and memory functions in a number of different diseases and therefore ACD856 may have a significant role in the treatment of several indications where these key functions are impaired, for example in Alzheimer’s disease, traumatic brain injury and Parkinson’s disease,” said AlzeCure Pharma’s CEO Martin Jönsson.
The article is available via the following link: https://link.springer.com/article/10.1007/s00228-024-03645-1
