AlzeCure's Alzheimer’s Project NeuroRestore ACD856 Shows Positive Effect on Brain Activity in Clinical Trial
STOCKHOLM, SE / ACCESSWIRE / September 16, 2022 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) 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 has received new data from the clinical phase I study (multiple ascending dose, MAD) with repeated dosing of the drug candidate ACD856, which is being developed against Alzheimer's disease and other indications with cognitive dysfunction.
New data from a planned exploratory analysis of the MAD study show that ACD856 increases EEG activity in the brain. A clear difference can be seen after vs. prior to administration of the substance. This result combined with previously reported data show that the substance not only crosses the blood-brain barrier, but also reaches and activates neural pathways in the brain, with the potential of having positive effects on cognition.
The MAD phase I study is AlzeCure's third clinical study with ACD856, the company's leading drug candidate within the NeuroRestore platform. 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. The primary study objective was to evaluate the drug candidate's tolerability and safety after repeated dosing. As previously reported, ACD856 shows good safety and tolerability in both the SAD and MAD studies.
ACD856 and the other substances in the NeuroRestore platform stimulate several important signaling systems and signaling substances in the brain such as BDNF (Brain Derived Neurotrophic Factor) and NGF (Nerve Growth Factor), which can lead to improved cognition, something that has been demonstrated in previous preclinical studies. New preclinical results also show potential neuroprotective and disease-modifying effects with these substances. The biological mechanism behind NeuroRestore enables several indications, such as Alzheimer's and Parkinson's disease, but also traumatic brain injury and depression.
"These new data are very promising and show that the substance reaches and activates neural pathways in the brain, whose normal function is disrupted in diseases such as Alzheimer's," said Johan Sandin, CSO at AlzeCure Pharma.
"These are very good news that add to the previous positive data for ACD856 and further strengthens our commercial opportunities for this promising substance," said Martin Jönsson, CEO.
For more information, please contact
Martin Jönsson, CEO
Tel: +46 707 86 94 43
About AlzeCure Pharma AB (publ)
AlzeCure® is a Swedish pharmaceutical company that develops new innovative small molecule drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer's disease and pain - indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless.
NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer's disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson's disease. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer's disease and comprises two drug candidates. Painless is the company's research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets other types of severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase and is continually working on business development to find suitable solutions for license agreements with other pharmaceutical companies.
FNCA Sweden AB is the company's Certified Adviser. For more information, please visit www.alzecurepharma.se
NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive ability is impaired, e.g. Alzheimer's Disease, sleep apnea, traumatic brain injury and Parkinson's disease. NeuroRestore stimulates several important signaling pathways in the brain, which among other things leads to improved cognition. In preclinical studies with NeuroRestore, we have been able to show that our drug candidates enhance communication between the nerve cells and improve cognitive ability. NeuroRestore stimulates specific signaling pathways in the central nervous system known as neurotrophins, the most well-known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). The levels of NGF and BDNF are disturbed in several disease states and the signaling is reduced. The impaired function impairs communication between the synapses, i.e. the contact surfaces of the nerve endings, as well as reducing the possibility of survival for the nerve cells, which gives rise to the cognitive impairments. Neurotrophins play a crucial role for the function of nerve cells, and a disturbed function of BDNF has a strong genetic link to impaired cognitive ability in several different diseases, such as Alzheimer's, Parkinson's disease, traumatic brain injury and sleep disorders. There is also a link between BDNF signaling and depression, something that has been further strengthened in recent years.
In addition to cognitive-enhancing effects, new preclinical data also show that NeuroRestore substances have a positive effect on mitochondrial function and cell survival, which could indicate potential disease-modifying effects.
The leading drug candidate in the platform, ACD856, has recently completed phase I clinical studies and has shown positive effects that support continued development of the program.
SOURCE: AlzeCure Pharma
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