Leveraging over 3 decades of experience with cyclodextrins to advance clinically de-risked programs towards approval in diseases with unmet medical need.
Platform technology has demonstrated to be safe and effective with over 10 years of patient exposure.
FDA: Orphan Drug Designation (ODD), Fast-Track, Rare Pediatric Disease Designation, potential PRV; EMA: ODD and adopted PIP
Enrolling and dosing patients in Pivotal Phase 3 study in Niemann-Pick Disease Type C.
Significant market opportunity with no approved therapy to treat both systemic and neurological manifestations of NPC.
Pipeline expansion into Alzheimer's Disease (AD), patent filed globally and is currently being prosecuted.
Received Study May Proceed from FDA December 2021, FPI targeted H2 2022.
Cash Balance
Market Cap
Shares Outstanding
Average Volume
$11.8M
~19M*
8.4M
~42K
*As of May 31, 2022
Our Mission
Our Team
We are dedicated to developing life-changing medicines through science and innovation for patients and families living with challenging diseases.
Our lead therapeutic asset, 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. 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 that it can be further processed and excreted out of cells.
N. Scott Fine
Joshua M. Fine
Lisa Lund Kjems, MD, PhD
CFO
CMO
CEO
Michael Lisjak
Lori McKenna Gorski
Jeffrey L. Tate, PhD
Global Head of Patient
CRO, SVP for Business
Advocacy
Director, COO, CQO
Development
Platform Technology Pipeline
Trappsol® Cyclo™ allows for a multiple shots on goal model
Program
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Milestones
Trappsol® Cyclo™ Niemann-Pick Disease Type C
Trappsol® Cyclo™ Alzheimer's Disease
(Pivotal Phase 3 Study)
Site activation ongoing, enrolling and dosing patients.
Open IND for Phase 2 study
Orphan Drug Designation in U.S. | Fast Track Status in U.S. | Potential for Priority Review Voucher (PRV) in U.S.
Orphan Drug Designation in EU | EMA Pediatric Investigational Plan Adopted
Therapeutic Focus Areas
Niemann-Pick Disease Type C (NPC)
Rare, fatal and progressive genetic disorder affecting the brain, liver and spleen characterized by a defect in the NPC1 protein
Cholesterol and lipids accumulate in cells of major organs and tissues leading to cell and tissue dysfunction
1/100,000 instances of NPC
0 U.S. approved NPC therapies
1 E.U approved therapy with no systemic effects
Alzheimer's Disease
The most common form of
Dementia
An irreversible, progressive neurologic disorder that slowly degrades memory, thinking and social skills that affects a person's ability to function independently
Cyclo Therapeutics Inc. published this content on 03 June 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 June 2022 14:21:06 UTC.
Cyclo Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is focused on developing transformative therapies for rare and neurological diseases with limited treatment options. The Companyâs Trappsol Cyclo is a proprietary formulation of hydroxypropyl beta cyclodextrin. It is an orphan drug designated product in the United States and Europe, and is the subject of four formal clinical trials for Niemann-Pick Disease Type C (NPC) disease. NPC is a rare and fatal autosomal recessive genetic disease resulting in disrupted cholesterol metabolism that impacts the brain, lungs, liver, spleen, and other organs. The Company is also engaged in conducting a Phase 2b clinical trial using Trappsol Cyclo intravenously in early Alzheimerâs disease (NCT05607615) based on encouraging data from an Expanded Access program for Alzheimerâs disease (NCT03624842).