CYTH - Cyclo Therapeutics posts design protocol of pivotal late-stage study of Trappsol Cyclo

Cyclo Therapeutics (CYTH) announces the design of its protocol and is preparing to commence its pivotal Phase 3 study evaluating Trappsol Cyclo, a proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously, in the treatment of Niemann-Pick Disease type C1 ((NPC1)), a rare genetic disease affecting 1 in 100K live births globally.Both the FDA and EMA are in agreement with the company’s trial protocol and have given clearance to proceed with the study.The pivotal Phase 3 study will be a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2000 mg/kg of Trappsol Cyclo administered intravenously and standard of care ((SOC)) compared to placebo administered intravenously and SOC in patients with NPC1.The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries.Patient enrollment is on track to commence

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Cyclo Therapeutics posts design protocol of pivotal late-stage study of Trappsol Cyclo