Positive data from the MAD phase I clinical study with the Alzheimer’s project of AlzeCure NeuroRestore ACD856

STOCKHOLM, June 29, 2022 /PRNewswire/ — AlzeCure Pharma AB (publ) (FN STO: ALZCUR)a pharmaceutical company developing a broad portfolio of small molecule drug candidates for diseases affecting the central nervous system, with projects in Alzheimer’s disease and pain, announced today that the company has completed the phase I clinical study (multiple ascending doses, MAD) with repeated administration of the drug candidate ACD856, with a focus on Alzheimer’s disease.

The data shows that ACD856, the lead drug candidate of the company’s NeuroRestore platform, exhibits good tolerability and safety. Furthermore, the results demonstrate that the substance has appropriate pharmacokinetic properties with rapid absorption in the body as well as relevant and dose-dependent exposure in the CNS.

The Phase I MAD study is AlzeCure’s third clinical study with ACD856, the company’s lead drug candidate in the NeuroRestore platform. The substance is being developed as a symptom relief treatment for disease states where cognitive ability is impaired, for example in Alzheimer’s disease. The main objective of the study was to assess the tolerance, safety and pharmacokinetics of the drug candidate after repeated administration.

“We are very pleased that ACD856 has a very good profile for further clinical development,” said John Sandin, CSO at AlzeCure Pharma. “With its potential to improve memory function in various diseases, ACD856 may play an important role in treating indications where these key functions are impaired, such as Alzheimer’s disease, sleep apnea, traumatic brain injury and Parkinson’s disease.”

The company began the study in September 2021 and now presents as planned the results of this clinical study with ACD856. Preparations are underway to launch new clinical trials. These upcoming studies focus on evaluating signals of early effects in humans.

“The results of the NeuroRestore ACD856 candidate follow previous positive clinical results with the substance, and we now look forward to continued clinical studies,” said Martin Jönsson, CEO of AlzeCure. “I also see this data will stimulate potential partnerships and licensing discussions and increase interest in the NeuroRestore platform.”

For more information please contact:

Martin Jonsson, CEO
Tel: +46 (0)70-786 94 43
E-mail: [email protected]

This is information that AlzeCure Pharma AB is required to make public under the EU Market Abuse Regulation. The information has been submitted for publication, through the agency of the contact person above, to 1:00 p.m. CEST on June 29, 2022.

About AlzeCure Pharma AB (publ)

AlzéCure® is a Swedish pharmaceutical company that develops innovative new small molecule drug therapies for the treatment of serious diseases and conditions that affect the central nervous system, such as Alzheimer’s disease and pain – indications for which Currently available treatments are very limited. The company is listed on the Nasdaq First North Premier Growth Market and is developing multiple parallel drug candidates based on three research platforms: NeuroRestore®Alzstatin® and Painless.

NeuroRestore consists of two symptomatic drug candidates whose unique mechanism of action enables multiple indications, including Alzheimer’s disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinsons. The Alzstatin platform focuses on the development of disease-modifying and preventive drug candidates for the early treatment of Alzheimer’s disease and includes two drug candidates.

Painless is the Company’s pain research platform and contains two projects: ACD440, which is a drug candidate in clinical development 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 to an early clinical phase and continuously works on commercial development to find suitable solutions for licensing agreements with other pharmaceutical companies.

FNCA Sweden AB, +46(0)8 528 00 399 [email protected], is the company’s certified advisor. For more information, please visit www.alzecurepharma.se.

About NeuroRestore

NeuroRestore is a platform of symptom-relieving drug candidates for disease states in which cognitive abilities are impaired, eg 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 were able to show that our drug candidates improve communication between nerve cells and improve cognitive abilities. NeuroRestore stimulates specific central nervous system signaling pathways called neurotrophins, the best known being NGF (Nerve Growth Factor) and BDNF (Brain Derived Neurotrophic Factor). NGF and BDNF levels are disrupted in several disease states and signaling is reduced. The impaired function impairs communication between synapses, i.e. the contact surfaces of nerve endings, as well as the possibility of nerve cell survival, giving rise to cognitive impairment. Neurotrophins play a crucial role for nerve cell function, and impaired BDNF function has a strong genetic link with impaired cognitive ability in several different diseases, such as Alzheimer’s disease, Parkinson’s disease, brain injury trauma and sleep disorders. There is also a link between BDNF signaling and depression, which has grown even stronger in recent years.

About Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia, affecting approximately 50 million people worldwide. Alzheimer’s disease is a fatal disease that also has a significant impact on loved ones and society. Today, preventive and disease-modifying treatments are lacking. The main risk factors for developing Alzheimer’s disease are age and genetic causes. Although the disease can begin between the ages of 40 and 65, it is more common after the age of 65. Significant investments in Alzheimer’s disease research are being made due to the large unmet medical need and high cost of this disease to health care and society. The total global cost of dementia-related illnesses is estimated at approximately 1 trillion dollars. Given the lack of effective symptomatic treatments and disease-modifying treatments, the need for new effective therapies is acute. The few approved drugs on the market today have only limited symptomatic effect and may produce dose-limiting side effects. Modifying therapy for Alzheimer’s disease is estimated to reach more than $15 billion in annual sales. In Swedenabout 100,000 people suffer from Alzheimer’s disease with a health cost of about 63 billion Swedish crowns annually, which is more than for cancer and cardiovascular diseases combined.

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