CYTH - Cyclo Therapeutics to proceed with IND filing for mid-stage alzheimer's disease trial
Cyclo Therapeutics ([[CYTH]] +2.0%) has received feedback from the U.S. FDA supporting the company’s development strategy to submit an initial new drug application application for a Phase 2 study of Trappsol Cyclo in the treatment of early Alzheimer’s disease.The company said that it is on track to file its IND in the second half of this year.Cyclo also said that it 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)), a rare genetic disease causing cholesterol accumulation in cells, is expected to commence this quarter. The company had announced positive topline data from its Phase 1/2 clinical trial, which showed promising safety and efficacy results for Trappsol Cyclo in the treatment of Niemann-Pick Disease type C1, last month.
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Cyclo Therapeutics to proceed with IND filing for mid-stage alzheimer’s disease trial