On July 27, the Cyclo Therapeutics, a clinical stage biotechnology firm dedicated to developing life-changing medicines through science and innovation for patients, announced that they have accomplished to produce commercial-scale amounts of batches of Trappsol®Cyclo™, their proprietary formulation of 2-hydroxypropyl beta cyclodextrin.
Dr. Jeffrey Tate, Chief Operating Officer of Cyclo Therapeutics, Inc. said that the company’s scalable, robust and validated manufacturing process has been a cornerstone of company’s capabilities. This technological development enables them to move forward smoothly and quickly with their patient treatment programs. The production of the first commercial-scale cGMP batches of Trappsol® Cyclo™ allows the company to establish „Chemistry and Manufacturing Controls” section of their regulatory documents, which is required by the relevant authorities (FDA, EMA), for the approval and commercialization of this cyclodextrin drug substance. The resulting drug product inventory of Trappsol® Cyclo™ will also be used to support the company’s so called „TransportNPC™” program, their ongoing pivotal clinical Phase 3 study for treatment of Niemann-Pick Type C disease, (NPC) and an upcoming Phase 2 study targeting Alzheimer’s disease therapy.
Trappsol® Cyclo™ is the company’s proprietary formulation of hydroxypropyl beta cyclodextrin. This cyclodextrin derivative has an affinity for cholesterol. In multiple clinical studies, Trappsol® Cyclo™ has shown encouraging results to effectively manage cellular cholesterol trafficking. Unlike other clinical programs with hydroxypropyl beta cyclodextrin, the TransportNPC™ trial uses an intravenous route of administration that supports the ability of the cyclodextrin to reach major peripheral organs, to mobilize and clear cholesterol from cells peripherally and centrally. Moreover, this effectively target a range of central nervous system biomarkers and underpin neurologic outcomes as demonstrated in the Company’s current data from a number of completed and ongoing studies. Cyclo Therapeutics received Orphan Drug Designation for their Trappsol® Cyclo™ to treat NPC1 in both the US and EU and Fast Track and Rare Pediatric Disease Designations in the US. The Rare Pediatric Disease Designation is one of the key requirements for sponsors to receive a „Priority Review Voucher” in the US upon marketing authorization. Cyclo Therapeutics is also planning to evaluate their prorpietary hydroxypropyl-beta-cyclodextrin for the treatment of Alzheimer’s disease, targeting the reduction of amyloid beta and tau proteins.
The Company recently received positive feedback supporting their development strategy to submit an Initial New Drug application (IND) for a Phase 2 study of intravenous Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease. Cyclo Therapeutics is ready to file an IND document for a Phase 2 study of Alzheimer’s disease during the second half of this year.
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