CYTH
Industry:
Pharma & Biotech Chemicals

DESCRIPTION

Cyclo Therapeutics is a clinical-stage biotech company developing Trappsol Cyclo (hydroxypropyl beta cyclodextrin) for Niemann-Pick Type C disease (NPC), an ultra-rare fatal genetic disorder in which cells cannot properly process cholesterol and lipids, leading to toxic accumulation in the brain and organs and progressive neurological decline. Trappsol Cyclo works by clearing toxic cholesterol deposits from cells and is administered intravenously every two weeks. The company is currently running TransportNPC, a pivotal Phase III trial enrolling up to 93 patients globally, which is the key catalyst for potential FDA approval. Cyclo Therapeutics also has an earlier-stage Phase II study of Trappsol Cyclo for Alzheimer's disease, given biological overlaps between NPC and Alzheimer's. The company's business model is a classic clinical-stage biotech: fund R&D now with the goal of eventual drug approval and commercial sales. Trappsol Cyclo holds FDA Fast Track designation, Orphan Drug Designation (providing seven years of U.S. market exclusivity post-approval), and Rare Pediatric Disease designation, which would unlock a transferable priority review voucher upon approval. Cyclo Therapeutics also runs a small legacy cyclodextrin distribution business under its Trappsol and Aquaplex brands, selling to pharmaceutical, diagnostics, and industrial customers — this currently generates substantially all company revenue but is secondary to the core drug development mission.

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