Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol® Cyclo™

Rhea-AI Summary

Cyclo Therapeutics (Nasdaq: CYTH) has announced the commercial-scale production of Trappsol® Cyclo™, its proprietary hydroxypropyl beta cyclodextrin formulation. This manufacturing milestone supports ongoing clinical trials for Niemann-Pick Disease Type C1 and Alzheimer’s disease. The company has received Orphan Drug Designation for Trappsol® Cyclo™ in the US and EU, alongside Fast Track and Rare Pediatric Disease Designations. Cyclo Therapeutics aims to file an IND for a Phase 2 study in Alzheimer’s treatment by late 2021.

Positive

• Commenced commercial-scale production of Trappsol® Cyclo™, crucial for regulatory approvals.
• Received Orphan Drug Designation in the US and EU for treating Niemann-Pick Disease Type C1.
• Planning Phase 2 study for Alzheimer’s, backed by positive FDA feedback.

Negative

• None.

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.gov NCT02939547, 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.

Safe Harbor Statement

This press release contains “forward-looking statements” about the company’s current expectations about future results, performance, prospects and opportunities, including, without limitation, statements regarding the satisfaction of closing conditions relating to the offering and the anticipated use of proceeds from the offering. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual results in future periods to differ materially from what is expressed in, or implied by, these statements. The factors which may influence the company’s future performance include the company’s ability to obtain additional capital to expand operations as planned, success in achieving regulatory approval for clinical protocols, enrollment of adequate numbers of patients in clinical trials, unforeseen difficulties in showing efficacy of the company’s biopharmaceutical products, success in attracting additional customers and profitable contracts, and regulatory risks associated with producing pharmaceutical grade and food products. These and other risk factors are described from time to time in the company’s filings with the Securities and Exchange Commission, including, but not limited to, the company’s reports on Forms 10-K and 10-Q. Unless required by law, the company assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210727005149/en/

FAQ

What is the latest update from Cyclo Therapeutics regarding Trappsol® Cyclo™?

Cyclo Therapeutics has begun commercial-scale production of Trappsol® Cyclo™, supporting regulatory approvals and ongoing clinical trials.

What designations has Cyclo Therapeutics received for Trappsol® Cyclo™?

Trappsol® Cyclo™ has received Orphan Drug Designation in the US and EU, along with Fast Track and Rare Pediatric Disease Designations.

When does Cyclo Therapeutics plan to file its IND for Alzheimer’s disease?

Cyclo Therapeutics plans to file its IND for a Phase 2 study of Trappsol® Cyclo™ in Alzheimer’s disease in the second half of 2021.

What diseases is Trappsol® Cyclo™ being evaluated for?

Trappsol® Cyclo™ is being evaluated for Niemann-Pick Disease Type C1 and Alzheimer’s disease.