Cyclo Therapeutics Commences Commercial-Scale Manufacturing for Trappsol® Cyclo™
July 27 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
that it has commenced the commercial-scale production of batches of
Trappsol® Cyclo™, the Company’s proprietary formulation of
hydroxypropyl beta cyclodextrin.
“Cyclo Therapeutics’ robust, scalable and validated
manufacturing process has been a cornerstone of our capabilities
and enables us to move forward with all of our patient treatment
programs,” said Jeffrey L. Tate, Ph.D., Chief Operating Officer and
Chief Quality Officer of Cyclo Therapeutics. “The production of our
first commercial-scale cGMP batches of Trappsol® Cyclo™ allows us
to execute on the necessary Chemistry and Manufacturing Controls
(CMC) section required by the FDA, and other regulatory
authorities, for potential approval and commercialization.
Additionally, the resulting drug product inventory will be used to
support TransportNPC™, our ongoing pivotal Phase 3 study in
Niemann-Pick Disease Type C1, an upcoming Phase 2 study for our
Alzheimer’s disease asset, and our active compassionate use
program.”
Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl
beta cyclodextrin and has an affinity for cholesterol. In multiple
clinical studies, Trappsol® Cyclo™ has shown encouraging results to
effectively manage the transportation of cholesterol. Unlike other
clinical programs with hydroxypropyl beta cyclodextrin, the
TransportNPC™ trial uses an intravenous route of administration
that supports the ability of the drug to reach major peripheral
organs, clear cholesterol from cells peripherally and centrally,
effectively target a range of CNS biomarkers and underpin
neurologic outcomes as demonstrated in the Company’s current data
from its completed and ongoing studies.
“I am incredibly proud of our team and the tremendous effort to
advance Cyclo Therapeutics to this stage of commercial-scale
manufacturing for Trappsol® Cyclo™. This milestone brings us one
step closer to our ultimate goal of providing patients, families
and caregivers with hope and a potential treatment option for two
diseases with significant unmet need,” added N. Scott Fine, Chief
Executive Officer of Cyclo Therapeutics.
Trappsol® Cyclo™ is currently being evaluated in the
TransportNPC™ study for the treatment of Niemann-Pick Disease Type
C1 (“NPC1”), a rare, progressive and fatal genetic disorder. As
previously announced, Cyclo Therapeutics received Orphan Drug
Designation for Trappsol® Cyclo™ to treat NPC1 in both the US and
EU and Fast Track and Rare Pediatric Disease Designations in the
US. The Rare Pediatric Disease Designation is one of the chief
requirements for sponsors to receive a Priority Review Voucher in
the US upon marketing authorization.
Cyclo Therapeutics is also planning to evaluate Trappsol® Cyclo™
for the treatment of Alzheimer’s disease, targeting the reduction
of amyloid beta and tau. Following a Type B interaction with the
FDA, Cyclo Therapeutics received positive feedback supporting the
Company’s development strategy to submit an Initial New Drug (IND)
application for a Phase 2 study of intravenous Trappsol® Cyclo™ in
the treatment of early Alzheimer’s disease. The Company is on track
to file its IND for a Phase 2 study of Alzheimer’s disease in the
second half of 2021.
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 three
ongoing 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/20210727005149/en/
Investor Contact: JTC Team, LLC Jenene Thomas (833)
475-8247 CYTH@jtcir.com
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