CTD Holdings Inc. filed a clinical trial application with Italy's drug regulator Agenzia Italiana del Farmaco to conduct a Phase 1/2 clinical trial of Trappsol Cyclo in Italy.

Trappsol Cyclo is intended for the treatment of Niemann-Pick disease type C, a rare genetic, neurodegenerative disorder that causes progressive deterioration of the nervous system.

CTD's plans for the trials include administering the drug intravenously to patients in Italy as young as two years old and into adulthood. The study will evaluate the safety and tolerability of three doses of the drug, its effects on the body and how the body metabolizes the drug.

Results will be checked for cholesterol synthesis and cholesterol degradation as well as clinical assessments of swallowing, lung function, cognitive ability and fine motor skills.

The product candidate previously received an orphan drug designation in both the EU and the U.S.