IDiA Announces Positive Results from Phase 3 Precision Study
Top-Line Data Shows Promise for New Alzheimer's Treatment
Switzerland, March 20, 2024
IDIA today announced positive top-line results from the PRECISION Phase 3 study investigating the efficacy and safety of its investigational Alzheimer's treatment, IDP-123. The study met its primary endpoint, demonstrating a statistically significant reduction in cognitive decline compared to placebo in patients with mild cognitive impairment due to Alzheimer's disease.
"These results are extremely encouraging and provide strong evidence for the potential of IDP-123 to improve the lives of patients with Alzheimer's disease," said Dr. Bernard Gentsch, CEO of IDIA. "We are grateful to the patients and their families who participated in the PRECISION study and to the investigators who conducted the research."
The PRECISION study was a randomized, double-blind, placebo-controlled study of IDP-123 in patients with mild cognitive impairment due to Alzheimer's disease. The study enrolled over 1,500 patients at over 100 sites in the United States and Europe. Patients were randomized to receive either IDP-123 or placebo for 18 months.
The primary endpoint of the study was the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 18 months. The ADAS-Cog11 is a measure of cognitive function that is commonly used in Alzheimer's disease clinical trials. The study also assessed secondary endpoints, including changes from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Neuropsychiatric Inventory (NPI).
The results of the study showed that IDP-123 met its primary endpoint, demonstrating a statistically significant reduction in cognitive decline compared to placebo. The mean change from baseline in the ADAS-Cog11 at 18 months was -1.5 points in the IDP-123 group compared to -2.2 points in the placebo group (p<0.05).
IDP-123 was also well-tolerated, with no new safety concerns identified. The most common adverse events were headache, nausea, and diarrhea, which were generally mild to moderate in severity.
"We are very pleased with the results of the PRECISION study," said Dr. Alfred Sandrock, Chief Medical Officer of IDIA. "We believe that IDP-123 has the potential to be a valuable new treatment option for patients with Alzheimer's disease and we look forward to continuing our research and development efforts in this area."
IDIA plans to submit the results of the PRECISION study to regulatory authorities in the United States and Europe in the second half of 2024. If approved, IDP-123 would be the first new treatment for Alzheimer's disease in nearly two decades.
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