Cyclo Therapeutics, Inc. announced the last patient has been enrolled in the Company?s pivotal Phase 3 study evaluating Trappsol Cyclo for the treatment of systemic and neurological symptoms of Niemann-Pick Disease Type C1 (NPC1). The TransportNPC study is the most comprehensive controlled pivotal study regarding patient size, global footprint, duration and clinical outcomes of an investigational therapy for NPC1. The study has dosed its 93rd (final) and 94th (over enrolled) patients.

Additionally, the Company has enrolled ten (10) patients in its substudy per their adopted Paediatric Investigational Plan (PIP) treating newborn to 3 years of age. The substudy is evaluating Trappsol Cyclo in the youngest age subsets as it targets also the visceral aspects of the disease and may achieve its most optimal results when administered early in the disease course, thus having the potential of a preventative effect in overall symptom development. The Company?s ongoing TransportNPC study is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol Cyclo administered intravenously and standard of care (SOC), compared to placebo administered intravenously and SOC alone, in patients with NPC1, a rare, genetic disease causing cholesterol accumulation in cells, leading to dysfunction of the liver, lung, spleen and brain and premature death.

The study duration is a 96-week study, with a 48-week comparative interim analysis. Should the 48-week interim data meet statistical significance, the Company, in alignment with the FDA and EMA, intends to submit marketing applications for approval based on the 48-week interim data. The Company?s ongoing single-arm sub-study is evaluating patients from birth to less than 3 years of age with NPC1 irrespective of symptoms to evaluate safety and to obtain descriptive data on global disease severity and the response to Trappsol Cyclo.

The substudy is being conducted in countries outside of the United States per their adopted PIP.