Cyclo Therapeutics, Inc., a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, announced that it has received feedback from the U.S. Food and Drug Administration (“FDA”) supporting the Company’s development strategy to submit an initial new drug application (“IND”) application for a Phase 2 study of Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease, following a positive Type B interaction.
The Company is currently advancing its lead product candidate of Trappsol® Cyclo™ in a pivotal Phase 3 study for the treatment of Niemann-Pick Type C (NPC1), expected to commence this quarter. Cyclo Therapeutics’ Alzheimer’s disease program is the second pipeline candidate program generated from the Company’s platform technology. The Company is on track to file its IND for a Phase 2 study of Alzheimer’s disease in the second half of this year.
The Company filed an international patent application titled “Methods for Treating Alzheimer’s Disease,” published as International Publication Number: WO 2020/092107 Al.