Cyclo Therapeutics Submits Investigational New Drug Application to U.S. FDA to Advance Trappsol® Cyclo™ in Phase 2 Study for Treatment of Alzheimer’s Disease
17 November 2021 - 12:05AM
Business Wire
– Biologic similarities demonstrated between
Niemann-Pick Disease Type C and Alzheimer’s Disease, including
cholesterol accumulation in regions of the brain, elevated levels
of Tau in CSF, and amyloid plaques in the brain, bolsters rationale
for studying Trappsol® Cyclo™ for the treatment of early
Alzheimer’s Disease
– Phase 2 protocol was developed based clinical
data from completed and ongoing trials in Niemann-Pick Disease Type
C and on 18 months of data from a single late-onset Alzheimer’s
patient being administered monthly intravenous doses of Trappsol®
Cyclo™ under compassionate use
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 submitted its initial investigational new drug (“IND”)
application with the U.S. Food and Drug Administration (“FDA”) for
a Phase 2 study of Trappsol® Cyclo™ for the treatment of early
Alzheimer’s Disease (AD).
“We are excited to have submitted our Initial IND to evaluate
Trappsol® Cyclo™ for the treatment of Alzheimer’s Disease. The
feedback and recommendations received from our Type B Meeting with
the FDA have provided valuable input that we believe positions us
for success in advancing this asset. We have taken another step
towards commencing our Phase 2 study and, importantly, bringing a
much-needed treatment option to patients and families,” commented
Michael Lisjak, Chief Regulatory Officer, Senior Vice President for
Business Development of Cyclo Therapeutics.
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 AD are associated
with cholesterol metabolism. Cholesterol imbalance in AD patients
is well known, and significant research exists suggesting these
imbalances are responsible for 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. AD shares features with NPC-1, 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
(CSF). Cyclo Therapeutics is currently testing the same
investigational Trappsol® Cyclo™ drug in clinical trials for the
treatment of Niemann-Pick Disease Type C1 (NPC-1). Taking the place
of the defective NPC-1 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.
“There remain significant unmet needs within the Alzheimer’s
Disease community, which we believe Trappsol® Cyclo™ is
well-positioned to address. We are committed to advancing this
important program as quickly and efficiently as possible following
feedback from FDA in the coming weeks,” added N. Scott Fine, Chief
Executive Officer of Cyclo Therapeutics.
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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version on businesswire.com: https://www.businesswire.com/news/home/20211116005289/en/
Investor Contact:
JTC Team, LLC Jenene Thomas (833) 475-8247 CYTH@jtcir.com
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