Patient enrollment and site activation now underway
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 the commencement of its Phase 2b study of Trappsol® Cyclo™ for the treatment of early Alzheimer’s disease (AD), targeting the reduction of amyloid beta and tau. The Phase 2b study has the regulatory and IRB approval required to commence patient enrollment, with site activation now underway.
Cynthia A. Lemere, PhD, Senior Advisor for the Company’s Alzheimer’s disease asset, commented: “I am excited to see the launch of Cyclo Therapeutics’ 6-month Phase 2b clinical trial in early Alzheimer’s disease. The pathophysiology of AD is complex and the relative contributions of the various pathogenic changes leading to disease progression warrant tailored therapies. Therefore, it is essential that we continue to evaluate novel investigational drugs such as Trappsol® Cyclo™. This important and well-designed study is expected to provide critical information.”
Dr. Martin Farlow, Professor of Neurology and Vice-Chairman of Research in the Department of Neurology at the Indiana University School of Medicine in Indianapolis, Associate Co-Director of the Indiana Alzheimer’s Disease Center in Indianapolis, and Director for the IU Center for Alzheimer’s Disease and Related Diseases at Indiana University Hospital commented, as the global Principal Investigator for Cyclo Therapeutics’ Phase 2b clinical trial in patients with Early Alzheimer’s Disease, commented: “I am very excited to see this study getting initiated. Cyclo Therapeutics’ Trappsol® Cyclo™ investigational drug shows promise in AD, based on the drug’s ability to stabilize disease progression in an AD patient. Notably, the ability of Trappsol® Cyclo™ to gain access to the CSF/brain and impact CSF tau and serum 24S-hydroxycholesterol when intravenously administered are most impressive and represent an exciting avenue for therapeutic development. As you know, the field of AD is actively searching for novel therapeutic approaches and Cyclo Therapeutics’ Trappsol® Cyclo™ is at the forefront of alternative disease-modifying therapeutics. I look forward to working with the Cyclo Therapeutics team on this important study with a trial design that will provide critical data and insights in developing this therapy.”
The Phase 2b study is a U.S. multicenter, randomized, placebo-controlled, double-blind, parallel group, 6-month study evaluating the safety, tolerability, and potential efficacy of monthly Trappsol® Cyclo™ infusions in patients with early Alzheimer’s disease. The study will enroll approximately 120 patients who have shown evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner report as documented by the Investigator. Enrolled patients will be randomized across three study arms: 500 mg/kg or 1000 mg/kg of Trappsol® Cyclo™ and Placebo. The study will consist of a screening period, treatment period up to 24 weeks, and a safety follow-up period.
N. Scott Fine, CEO of Cyclo Therapeutics commented, “We are pleased with the continued progress with our clinical development program for our Alzheimer’s disease asset. The commencement of this study and initiation of patient enrollment demonstrates our commitment and strategic execution utilizing Trappsol® Cyclo™ as a potential treatment option for patients and families who have been impacted by this devastating disease. We remain encouraged by the progress made in our Alzheimer’s disease program and look forward to building momentum.”
Cyclo Therapeutics is currently testing the same investigational Trappsol® Cyclo™ drug in a Phase 3 clinical trial (TransportNPC™) and a long-term extension study for the treatment of Niemann-Pick disease Type C1, a rare, fatal and progressive genetic disorder.
About Alzheimer’s Disease
Alzheimer’s disease is a progressive neurologic disorder that causes the brain to shrink (atrophy) and brain cells to die. Estimates vary, but experts suggest that more than 5.5 million Americans, most of them age 65 or older, may have dementia caused by Alzheimer’s. The early signs of the disease include forgetting recent events or conversations. As the disease progresses, a person with Alzheimer’s disease will develop severe memory and thinking skills impairment, then lose ability to learn, reason, make judgments, communicate and carry out daily activities. Medications may temporarily improve or slow progression of symptoms, however there is currently no treatment that cures Alzheimer’s disease or alters the disease process in the brain.
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 living with disease. The Company’s 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 conducting a Phase 2b clinical trial using Trappsol® Cyclo™ intravenously in early Alzheimer’s disease based on encouraging data from an Expanded Access program for 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.
JTC Team, LLC