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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20221004005431/en/
Investor Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
[email protected]
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