Cyclo Therapeutics, Inc., a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, has 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.
- 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.