Arctic Therapeutics, a clinical-stage biopharmaceutical company based in Iceland, has announced regulatory clearance from the European Medicines Agency to begin a Phase IIa clinical trial of its lead investigational therapy, AT-001, in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease. The multicenter, randomized, double-blind, placebo-controlled study will test the safety of AT-001 while examining its effects on innovative blood-based biomarkers and brain amyloid accumulation. This trial builds on Arctic Therapeutics’ ongoing work addressing both rare and common forms of dementia.
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“Alzheimer’s disease is one of the most pressing healthcare challenges worldwide,” said Dr. Hakon Hakonarson, founder of Arctic Therapeutics. “Early diagnosis combined with treatments that intervene sooner could fundamentally change how we treat Alzheimer’s and other dementias. Our goal is not only to slow disease progression but ultimately to prevent these conditions.” The trial follows a prior EMA approval for a Phase IIb/III study of AT-001 in hereditary cerebral amyloid angiopathy, a rare condition that can cause strokes and progressive neurological decline. AT-001 has also received Orphan Drug Designation for this ultra-rare disease, underscoring its potential as a disease-modifying therapy.
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Ivar Hakonarson, CEO and co-founder, emphasized the significance of these regulatory milestones, stating that the ODD designation highlights AT-001’s groundbreaking potential and lays the foundation for its development in Alzheimer’s disease. “This represents a major step forward in addressing critical unmet needs in both rare and more common dementias,” he said. “The approvals validate our approach and provide an important regulatory pathway to bring AT-001 to patients who urgently need new treatment options.”
The Phase IIa trial will enroll patients aged 50 to 85 across sites in Denmark and Iceland in collaboration with Sanos Group. Participants will receive escalating oral doses of AT-001 over 12 months with monthly safety labs, quarterly biomarker assessments, and imaging studies including MRI and PET scans. Key biomarkers will include plasma pTau217, total Tau, neurofilament light chain, and toxic amyloid-beta oligomers. MRI and PET imaging will track brain atrophy and amyloid burden, providing insights into how AT-001 may influence disease biology and clinical outcomes, complementing recent monoclonal antibody therapy studies.
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