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Cyclo Therapeutics has completed enrollment for its Phase 3 TransportNPC™ trial, the largest study of its kind for Niemann-Pick Disease Type C1 (NPC1). The study includes 104 patients and aims to evaluate the efficacy of Trappsol® Cyclo™ in treating systemic and neurological symptoms of NPC1.
Topline data from the 48-week interim analysis is expected in the first half of 2025. Positive results could lead to the submission of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in the second half of 2025.
The trial also features a substudy for newborns to 3-year-olds, targeting early-stage interventions. The company has received Orphan Drug Designation in both the U.S. and EU, Fast Track and Rare Pediatric Disease designations in the U.S., which could qualify them for a Priority Review Voucher.
Cyclo Therapeutics (Nasdaq: CYTH) reported its Q1 2024 financial results, highlighting ongoing progress in its TransportNPC™ Phase 3 study for Niemann-Pick Disease Type C1 (NPC1). The study expects to enroll the last patient by Q2 2024, with topline data anticipated in H1 2025. The company also received a U.S. patent for using Trappsol® Cyclo™ to treat Alzheimer's Disease.
Financially, Cyclo Therapeutics reported a net loss of $4.3 million for Q1 2024. However, research and development expenses decreased by 16% to $2.8 million due to reduced spending on the Alzheimer’s program and adjustments in personnel costs. The company ended the quarter with $2.9 million in cash.
Cyclo Therapeutics focuses on developing life-changing medicines, with Trappsol® Cyclo™ in multiple clinical trials for NPC1 and early Alzheimer’s disease.