Cyclo Therapeutics Receives IND Clearance from the U.S. FDA to Advance its Phase 2 Study of Trappsol® Cyclo™ for the Treatment of Alzheimer’s Disease
December 06 2021 - 8:05AM
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 it
has received notification that its study may proceed from the U.S.
Food and Drug Administration (“FDA”) for its initial
investigational new drug (“IND”) application for a Phase 2 study of
Trappsol® Cyclo™ for the treatment of early Alzheimer’s
disease.
“We are incredibly pleased with the interaction we’ve had with
the FDA throughout this initial IND process, culminating in their
decision for our proposed Phase 2 program to proceed. We look
forward to commencing the study and the potential to address the
need for an effective treatment option for all those affected by
this devastating disease,” commented Michael Lisjak, Chief
Regulatory Officer, Senior Vice President for Business Development
of Cyclo Therapeutics.
"Alzheimer’s disease shares characteristics with Niemann-Pick
disease Type C1 a neurovisceral, genetic disease in which
cholesterol accumulates in lysosomes, including progressive decline
in cognitive ability, amyloid beta plaques in the CNS, and
increased levels of tau in the cerebrospinal fluid. With the data
we’ve amassed to-date in both our Niemann-Pick disease Type C1
clinical program and the 18 months of data under compassionate use
for the treatment of Alzheimer’s disease, we believe we are
well-positioned for success in advancing Trappsol® Cyclo™ through
the clinic in order to address the unmet medical need that
physicians, patients and families are facing,” added Lise Kjems
M.D. PhD. Chief Medical Officer.
Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl
beta cyclodextrin, and in multiple clinical studies, has shown
encouraging results to effectively manage the transportation of
cholesterol. Many of the known risk factors for Alzheimer’s disease
are associated with cholesterol metabolism. Cholesterol imbalance
in Alzheimer’s patients is well known, and significant research
exists, suggesting these imbalances are responsible for amyloid
beta (Aβ) and tau accumulation. Furthermore, neurons, because of
their high metabolic demands, experience an increased level of
oxidative stress. Oxidative stress has also been linked to abnormal
cholesterol accumulation and processing.
“This milestone further demonstrates our vision of utilizing
Trappsol® Cyclo™ as a platform technology and is a strong
representation of our team’s commitment to the patient communities
and our stakeholders. While our current focus continues to be on
the development of novel therapies for two neurodegenerative
diseases, Niemann-Pick disease Type C1 and Alzheimer’s disease,
future activities will include assessing other viable applications
of Trappsol® Cyclo™ technology in order to expand our development
pipeline,” commented N. Scott Fine, Chief Executive Officer of
Cyclo Therapeutics.
Cyclo Therapeutics is currently testing the same investigational
Trappsol® Cyclo™ drug in a Phase 3 clinical trial and a long-term
extension study for the treatment of Niemann-Pick disease Type C1,
a rare, fatal and progressive genetic disorder. Taking the place of
the defective NPC1 protein, Trappsol® Cyclo™, with its cyclic
structure, facilitates the transport of accumulated cholesterol out
of cellular lysosomes so it can be further processed and excreted
out of cells. With the biologic similarities demonstrated between
Niemann-Pick disease Type C1 and Alzheimer’s Disease, including
cholesterol accumulation in regions of the brain, elevated levels
of Tau in cerebrospinal fluid (“CSF”), and amyloid plaques in the
brain, the Company believes Trappsol® Cyclo™ has significant
potential to be an effective treatment option for Alzheimer’s
disease.
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. Most people with Alzheimer’s have the late-onset
form of the disease, in which symptoms become apparent in their
mid-60s. Early-onset Alzheimer’s disease occurs between a person’s
30s and mid-60s and represents less than 10 percent of all people
with 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 suffering from
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 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.
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Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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