GAINESVILLE, Fla. – Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that it has commenced the commercial-scale production of batches of Trappsol® Cyclo™, the Company’s proprietary formulation of hydroxypropyl beta cyclodextrin.
“Cyclo Therapeutics’ robust, scalable and validated manufacturing process has been a cornerstone of our capabilities and enables us to move forward with all of our patient treatment programs,” said Jeffrey L. Tate, Ph.D., Chief Operating Officer and Chief Quality Officer of Cyclo Therapeutics. “The production of our first commercial-scale cGMP batches of Trappsol® Cyclo™ allows us to execute on the necessary Chemistry and Manufacturing Controls (CMC) section required by the FDA, and other regulatory authorities, for potential approval and commercialization. Additionally, the resulting drug product inventory will be used to support TransportNPC™, our ongoing pivotal Phase 3 study in Niemann-Pick Disease Type C1, an upcoming Phase 2 study for our Alzheimer’s disease asset, and our active compassionate use program.”
Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin and has an affinity for cholesterol. In multiple clinical studies, Trappsol® Cyclo™ has shown encouraging results to effectively manage the transportation of cholesterol. Unlike other clinical programs with hydroxypropyl beta cyclodextrin, the TransportNPC™ trial uses an intravenous route of administration that supports the ability of the drug to reach major peripheral organs, clear cholesterol from cells peripherally and centrally, effectively target a range of CNS biomarkers and underpin neurologic outcomes as demonstrated in the Company’s current data from its completed and ongoing studies.
“I am incredibly proud of our team and the tremendous effort to advance Cyclo Therapeutics to this stage of commercial-scale manufacturing for Trappsol® Cyclo™. This milestone brings us one step closer to our ultimate goal of providing patients, families and caregivers with hope and a potential treatment option for two diseases with significant unmet need,” added N. Scott Fine, Chief Executive Officer of Cyclo Therapeutics.
Trappsol® Cyclo™ is currently being evaluated in the TransportNPC™ study for the treatment of Niemann-Pick Disease Type C1 (“NPC1”), a rare, progressive and fatal genetic disorder. As previously announced, Cyclo Therapeutics received Orphan Drug Designation for 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 chief requirements for sponsors to receive a Priority Review Voucher in the US upon marketing authorization.
Cyclo Therapeutics is also planning to evaluate Trappsol® Cyclo™ for the treatment of Alzheimer’s disease, targeting the reduction of amyloid beta and tau. Following a Type B interaction with the FDA, Cyclo Therapeutics received positive feedback supporting the Company’s development strategy to submit an Initial New Drug (IND) application for a Phase 2 study of intravenous Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease. The Company is on track to file its IND for a Phase 2 study of Alzheimer’s disease in the second half of 2021.
About Cyclo Therapeutics
Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from disease. The Company’s Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, is the subject of three ongoing formal clinical trials for Niemann-Pick Disease Type C, a rare and fatal genetic disease, (www.ClinicalTrials.govNCT02939547, NCT02912793, NCT03893071 and NCT04860960). The Company is planning an early phase clinical trial using Trappsol® Cyclo™ intravenously in Alzheimer’s Disease based on encouraging data from an Expanded Access program for late-onset Alzheimer’s Disease (NCT03624842). Additional indications for the active ingredient in Trappsol® Cyclo™ are in development. For additional information, visit the Company’s website: www.cyclotherapeutics.com.
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JTC Team, LLC