STOCKHOLM, Sweden – June 16, 2026. AlzeCure Pharma AB (publ), a clinical-stage biotechnology company focused on developing innovative treatments for neurological disorders, today announced positive results from its Phase Ib clinical study of ACD856, the lead drug candidate within its NeuroRestore platform being developed for Alzheimer’s disease and other neurodegenerative and psychiatric indications.
The Phase Ib study, which was completed on schedule, evaluated the safety, tolerability, and pharmacokinetic profile of repeated administration of ACD856 at higher dose levels than those previously studied in earlier clinical phases. According to the company, the findings further support the continued clinical advancement of the candidate and provide important insights for future Phase II trial design.
Strong Safety Profile And Dose Progression Support Continued Development
AlzeCure reported that ACD856 was well tolerated across all tested dose levels in the study. Importantly, no substance-related safety concerns or unexpected adverse findings were observed during the trial period. This reinforces earlier clinical data suggesting that the compound has a favorable safety profile suitable for further clinical development in patient populations.
In addition to safety and tolerability, the study also evaluated pharmacokinetic parameters, including how the compound is absorbed and distributed in the body. Researchers observed an expected increase in ACD856 concentrations in both blood plasma and cerebrospinal fluid (CSF), confirming that the compound successfully reaches the central nervous system.
These results are particularly significant in the context of Alzheimer’s disease drug development, where effective brain penetration remains a key challenge. The ability of ACD856 to reach the brain at measurable and consistent levels strengthens confidence in its mechanism of action and therapeutic potential.
Mechanism Of Action And NeuroRestore Platform Strategy
ACD856 is part of AlzeCure’s NeuroRestore platform, which focuses on developing symptomatic treatments that enhance cognitive function by targeting specific signaling pathways in the brain. The platform is based on Trk-PAM (tropomyosin receptor kinase positive allosteric modulation) mechanisms, which enhance the activity of neurotrophins such as BDNF (brain-derived neurotrophic factor) and NGF (nerve growth factor).
These neurotrophins play a central role in maintaining neuronal communication, synaptic plasticity, and nerve cell survival. Reduced signaling in these pathways has been associated with cognitive decline in multiple neurological conditions, including Alzheimer’s disease, Parkinson’s disease, traumatic brain injury, and sleep-related disorders.
By enhancing these pathways, NeuroRestore drug candidates aim to improve communication between neurons and support cognitive processes such as memory and learning. Preclinical research has also indicated that compounds within this platform may provide neuroprotective, anti-inflammatory, and mitochondrial benefits, suggesting potential broader therapeutic effects beyond symptom relief.
Clinical Data Supports Broader Therapeutic Potential
Beyond Alzheimer’s disease, AlzeCure highlighted that emerging evidence suggests ACD856 may have potential applications in other neurological and psychiatric conditions. Earlier clinical and preclinical studies have shown that the compound can influence brain pathways involved in cognition and mood regulation, which may open opportunities for future development in areas such as depression.
The company noted that previous studies have confirmed the compound’s ability to cross the blood-brain barrier and activate neural pathways associated with cognitive enhancement. This supports ongoing efforts to evaluate broader indications within the NeuroRestore program.
Patient Exposure And Safety Monitoring
To date, more than 70 participants have received ACD856 across clinical studies. According to AlzeCure, no significant safety concerns have been reported in this population. The accumulated safety data, combined with the latest Phase Ib results, provide a growing foundation for continued clinical progression.
The Phase Ib study specifically aimed to expand the understanding of dosing ranges and ensure that higher exposures remain well tolerated. The results are expected to support dose selection for upcoming Phase II studies, which will evaluate the compound in patient populations.
Preparation For Phase II Clinical Development
With the successful completion of Phase Ib, AlzeCure Pharma is now preparing for the next stage of clinical development. The company is advancing toward Phase II studies in Alzheimer’s disease, with additional potential indications under evaluation.
The planned Phase II program is expected to further assess the efficacy of ACD856 in improving cognitive function in patients, while continuing to monitor long-term safety and tolerability. The company aims to build on the strong pharmacological profile demonstrated in earlier stages to explore meaningful clinical outcomes.
The NeuroRestore program has also received support from external funding sources, including a grant from the European Innovation Council (EIC), highlighting the broader recognition of its scientific and therapeutic potential.
Management Commentary
According to Märta Segerdahl, Chief Medical Officer at AlzeCure Pharma, the Phase Ib results reinforce confidence in the development path for ACD856.
“The results are consistent with our previous findings and confirm that ACD856 is well tolerated, even at higher dose levels,” Segerdahl said. “The observed pharmacokinetic profile, including brain exposure, is particularly encouraging and provides a strong foundation for selecting doses in future studies.”
Chief Executive Officer Martin Jönsson also emphasized the strategic importance of the results.
“This is an important milestone for AlzeCure and the NeuroRestore platform,” Jönsson said. “The data support a broader therapeutic window and strengthen our confidence in advancing ACD856 into Phase II clinical development. We also see potential for future applications in additional neurological conditions with high unmet medical need.”
About NeuroRestore
NeuroRestore is AlzeCure Pharma’s platform of symptomatic drug candidates designed to improve cognitive function in neurological disorders. The platform targets Trk receptor-mediated signaling pathways involved in neuronal growth, communication, and survival.
The approach is intended to enhance brain function by supporting neurotrophin activity, particularly BDNF and NGF, which are essential for synaptic health and cognitive performance. Dysfunction in these pathways has been linked to several neurodegenerative and psychiatric conditions.
About AlzeCure Pharma AB (publ)
AlzeCure Pharma AB is a Swedish clinical-stage biotechnology company developing innovative treatments for diseases affecting the central nervous system, including Alzheimer’s disease and pain disorders. The company operates multiple drug development platforms, including NeuroRestore, Alzstatin, and Painless.
Through its research programs, AlzeCure aims to advance novel therapies from early discovery through clinical development, with a focus on addressing significant unmet medical needs in neurology and psychiatry.
