Cyclo Therapeutics Announces Formation of Global Steering Committee Comprised of Leading Experts to Advise on the Global Phase 3 Clinical Development…

GAINESVILLE, Fla.--(BUSINESS WIRE)--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 the formation of a Global Steering Committee (GSC) to guide the pivotal Phase 3 global clinical development program of Trappsol Cyclo for the treatment of Niemann-Pick Disease Type C (NPC). As the Global Principal Investigator for the TransportNPC study, Caroline Hastings, MD serves as the senior scientific and clinical expert for the trial and will also chair the GSC.

Dr. Caroline Hastings, global principal investigator for TransportNPC and chair of the GSC, has been instrumental in assembling this high caliber Global Steering Committee with representation of renowned Key Opinion Leaders and clinical experts in NPC. It is another testimony of our commitment to serve the NPC community and deliver on the unmet medical needs. I feel humbled and privileged to be working with this outstanding group of professionals who are committed to advance science and clinical trials that can bring hope and treatment benefits to so many patients and their families, commented Lise Kjems, MD, PhD, Chief Medical Officer of Cyclo Therapeutics.

The Companys ongoing pivotal Phase 3 study, TransportNPC, is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol Cyclo administered intravenously and standard of care (SOC), compared to placebo administered intravenously and SOC alone, in patients with NPC1. The Phase 3 study intends to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1 in at least 23 study centers in 9 countries. Eligible patients will be randomized 2:1 to receive either Trappsol Cyclo or a placebo. Randomization will not be constrained based on patient age, nor will patient enrollment be gated by patient age. The study duration is 96 weeks and includes an interim analysis at 48 weeks.

Dr. Hastings, Global Principal Investigator for the TransportNPC trial and member of Cyclo Therapeutics Scientific Advisory Board added, I am very grateful by the overwhelmingly positive responses as I reached out to fellow scientists and physicians to invite them to join the Global Steering Committee. I am honored to be working alongside these wonderful colleagues with outstanding knowledge and expertise and who represent the excellent investigators taking part in the TransportNPC trial. Together, we have a very unique opportunity to further refine the scientific strategy for Trappsol Cyclo and help drive this important program toward potential approval.

NPC is a devastating neurodegenerative disease that needs more effective therapies. Given the clinical course and progressive nature of this disease, novel therapeutic strategies with the potential for disease modifying effects are necessary. The TransportNPC trial is unique as it is designed to demonstrate the long-term clinical benefits and potential for disease modification, commented Professor Roberto Giugliani, MD, PhD.

I have been caring for patients with NPC for more than 25 years. These patients urgently need better treatment options that will better halt the cruel, neurodegenerative course that this disease takes. In this study with cyclodextrin intravenously, I see an opportunity to improve the therapeutic offer, added Dr. Eugen Mengel.

The members of the TransportNPC Global Steering Committee are:

For more information about the Companys TransportNPC pivotal Phase 3 study, visit http://www.ClinicalTrials.gov and reference identifier NCT04860960.

Cyclo Therapeutics received Orphan Drug Designation for Trappsol Cyclo to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S. The Rare Pediatric Disease Designation is one of the chief requirements for sponsors to receive a Priority Review Voucher in the U.S. upon marketing authorization.

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 Companys Trappsol Cyclo, an orphan drug designated product in the United States and Europe, is the subject of four 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 Alzheimers Disease based on encouraging data from an Expanded Access program for late-onset Alzheimers Disease (NCT03624842). Additional indications for the active ingredient in Trappsol Cyclo are in development. For additional information, visit the Companys website: http://www.cyclotherapeutics.com.

Safe Harbor Statement

This press release contains forward-looking statements about the companys 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 companys future performance include the companys 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 companys 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 companys filings with the Securities and Exchange Commission, including, but not limited to, the companys 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.

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Cyclo Therapeutics Announces Formation of Global Steering Committee Comprised of Leading Experts to Advise on the Global Phase 3 Clinical Development...