AlzeCure's ACD856 Alzheimer's Drug Receives EU Funding for Phase 2 Trial
Key Insights
AlzeCure Pharma (search) has been awarded a €2.5 million grant from the European Innovation Council for its NeuroRestore ACD856 Alzheimer's treatment.
The funding will support a Phase IIa clinical trial to evaluate higher doses of ACD856 in Alzheimer's patients, building on its safety profile.
ACD856, a Trk-PAM, aims to enhance BDNF and NGF signaling, potentially improving memory and modifying the disease course.
AlzeCure Pharma (search) AB has secured a €2.5 million grant from the European Innovation Council (EIC) to advance its NeuroRestore ACD856 program for Alzheimer's disease (search) into a Phase IIa clinical trial. The funding will facilitate the evaluation of higher doses of ACD856 in patients, leveraging the drug's established safety profile from Phase I studies.
Novel Mechanism of Action
ACD856 is a first-in-class drug candidate, characterized as a positive allosteric modulator of Trk receptors (search) (Trk-PAM). This mechanism aims to amplify brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) signaling, which are crucial for neuronal communication and survival. Preclinical studies have indicated that ACD856 strengthens communication between nerve cells and improves cognitive functions, including learning and memory.
Clinical and Preclinical Evidence
Phase I clinical trials have demonstrated that ACD856 is safe and well-tolerated, with evidence of brain penetration and activation of brain regions relevant to cognition and depression. Furthermore, preclinical data suggest that ACD856 possesses neuroprotective, anti-inflammatory, and potentially disease-modifying effects.
Management Commentary
"We are delighted to have been awarded a €2.5m grant from the European Innovation Council (EIC) for our innovative Alzheimer's treatment," said Johan Sandin, Chief Scientific Officer at AlzeCure Pharma (search). Martin Jönsson, CEO of AlzeCure Pharma, added, "The grant we received from the European Innovation Council is a strong validation of NeuroRestore ACD856, which has a unique pharmacological mechanism that enables multiple indications, both neurodegenerative diseases such as Alzheimer's and Parkinson's disease (search), but also, for example, depression."
Alzheimer's Disease Context
Alzheimer's disease (search) affects approximately 55 million people worldwide, with projections estimating a tripling of this number in the next 30 years. The global costs associated with dementia-related diseases were estimated at $1.3 trillion in 2019, underscoring the urgent need for effective treatments. Current therapies offer limited symptomatic relief and can have dose-limiting side effects.
Future Directions
AlzeCure Pharma (search) is also presenting data on NeuroRestore ACD856 at the Alzheimer's Congress AD/PD 2025, further highlighting the potential of this novel therapeutic approach. The company aims to advance ACD856 through clinical development and explore potential outlicensing opportunities with other pharmaceutical companies.