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Details:
VAR 200 (2-hydroxypropyl-beta-cyclodextrin) is being developed to mediate removal of excess cholesterol that damages the kidneys’ filtration system (renal glomeruli podocytes) in patients with Diabetic Kidney Disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Nephrology Product Name: VAR 200
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2024
Details:
The combined company will focus on advancing Cyclo Therapeutics’ pivotal Phase 3 global study evaluating Trappsol Cyclo (hydroxypropyl beta cyclodextrin), an orphan drug designated product in the United States and Europe, for Niemann-Pick Disease Type C1 (NPC1).
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Cyclo Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger December 27, 2023
Details:
Trappsol Cyclo is a proprietary formulation of hydroxypropyl beta cyclodextrin being developed in phase 3 clinical trials for the potential treatment of Niemann-Pick Disease Type C1, a rare and fatal genetic disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
VAR 200 (2-hydroxypropyl-beta-cyclodextrin, 2HPβCD) is a phase 2a-ready drug in development which has potential to treat multiple kidney diseases, including diabetic kidney disease, rare kidney diseases, FSGS (focal segmental glomerulosclerosis) and Alport syndrome.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Nephrology Product Name: VAR 200
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: George Clinical
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 14, 2023
Details:
The combined company will focus on advancing Cyclo Therapeutics’ pivotal Phase 3 global study evaluating Trappsol Cyclo (hydroxypropyl beta cyclodextrin), an orphan drug designated product in the United States and Europe, for Niemann-Pick Disease Type C1 (NPC1).
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Cyclo Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Merger September 21, 2023
Details:
Cyclo Therapeutics intends to use the proceeds to support of its Trappsol Cyclo, a proprietary formulation of hydroxypropyl beta cyclodextrin being developed in clinical trials for the potential treatment of Niemann-Pick Disease Type C1, a rare, fatal and Alzheimer’s disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Rafael Holdings
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement August 02, 2023
Details:
Cyclo Therapeutics intends to use the proceeds for the support of its Trappsol Cyclo (hydroxypropyl beta cyclodextrin), an orphan drug designated product in the United States and Europe, under clinical trial for Niemann-Pick Disease Type C, a rare and fatal genetic disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Rafael Holdings
Deal Size: $5.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement June 05, 2023
Details:
Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin), effectively manages the transportation of cholesterol accumulated out of the cells by taking the place of the defective NPC1 protein. It is currently being evaluated for Early Alzheimer’s Disease and NPC1.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Details:
Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin), effectively manages the transportation of cholesterol accumulated out of the cells by taking the place of the defective NPC1 protein. It is currently being evaluated for Early Alzheimer’s Disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol Cyclo
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 09, 2023
Details:
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.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering January 04, 2023
Details:
Trappsol Cyclo (Hydroxypropyl beta cyclodextrin), It take the place of defective NPC1 protein and effectively manages cholesterol transportation, by capturing cholesterol with its cyclic structure, within the cell and transports it out of the cell.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 04, 2023
Details:
VAR 200 (2HPβCD) is a cholesterol efflux mediator in development to ameliorate renal lipid accumulation that damages the kidneys' filtration system. VAR 200 passively and actively removes excess lipids from the kidney and has potential to treat other glomerular diseases.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Nephrology Product Name: VAR 200
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
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.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $4.2 million Upfront Cash: Undisclosed
Deal Type: Public Offering December 30, 2022
Details:
Trappsol® Cyclo™ is a proprietary formulation of hydroxypropyl beta cyclodextrin. In Phase 1 data, Trappsol® Cyclo™ cleared cholesterol from the liver and improved peripheral and central nervous system biomarkers of cholesterol homeostasis.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2022
Details:
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.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol Cyclo
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2022
Details:
The support will enable company to advance clinical evaluation of cholesterol efflux mediator candidate (VAR 200) in patients with orphan renal disease, FSGS, and to progress the inflammasome ASC inhibitor candidate (IC 100) into Phase 1 trials.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Nephrology Product Name: VAR 200
Highest Development Status: Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Larkspur Health Acquisition
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Agreement September 27, 2022
Details:
Trappsol® Cyclo (hydroxypropyl beta cyclodextrin) an orphan drug designated product in the United States and Europe, is being studied in a Phase 3 pivotal clinical trial for Niemann-Pick Disease Type C, a rare and fatal genetic disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
Under the terms of the collaboration agreement, Wits and Cyclo Therapeutics plan to develop and coordinate projects or activities to further scientific advancement of the Company’s proprietary platform technology, Trappsol® Cyclo™.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Rare Diseases and Disorders Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of the Witwatersrand
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 24, 2022
Details:
Trappsol Cyclo is a proprietary formulation of hydroxypropyl beta-cyclodextrin is currently being evaluated in clinical trials for the potential treatment of Niemann-Pick Disease Type C1 has shown encouraging results to effectively manage the transportation of cholesterol.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2022
Details:
Company recieves IND for a Phase 2 study of Trappsol® Cyclo (Hydroxypropyl beta cyclodextrin) has shown encouraging results to effectively manage the transportation of cholesterol for the treatment of early Alzheimer’s disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol Cyclo
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
The Cyclo Therapeutics session will be held Friday, June 25, 2021, 11 AM – 12 PM AEST / Thursday, June 24, 2021, 9 PM – 10 PM EDT. During the session, Cyclo Therapeutics will discuss its proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2021
Details:
Study (“TransportNPC”) evaluating Trappsol® Cyclo™, a proprietary formulation of hydroxypropyl beta cyclodextrin, delivered intravenously, for the treatment of Niemann-Pick Disease Type C1 (NPC1).
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2021
Details:
Cyclo has received feedback from the USFDA supporting the Company’s development strategy to submit an initial new drug application application for a Phase 2 study of Trappsol® Cyclo™ in the treatment of early Alzheimer’s disease, following a positive Type B interaction.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol cyclo
Highest Development Status: IND EnablingProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 19, 2021
Details:
Trial data suggest that Trappsol® Cyclo™ overcomes the NPC1 defect by removing trapped cholesterol from cells both systemically and in the central nervous system (CNS).
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol cyclo
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2021
Details:
This adoption of the PIP paves the way for the potential submission of a MAA in Europe for Trappsol® Cyclo™ in the treatment of NPC1 following the completion of the pivotal Phase 3 study which is expected to commence in the second quarter of 2021.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
Data from ongoing Phase 1 extension study shows improvement in disease features or disease stabilization with home-based intravenous infusions of Trappsol® Cyclo™.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2021
Details:
Cyclo will present data on safety and mechanism of action from the completed Phase I clinical trial using the company’s proprietary formulation of hydroxypropyl beta cyclodextrin, Trappsol® Cyclo™ in patients 18 years and older.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 19, 2020
Details:
FDA has notified the company that enrollment can proceed for its Phase 3 global pivotal study evaluating Safety, Tolerability, and Efficacy of 2000 mg/kg of Trappsol® Cyclo™ and Standard of Care vs Placebo and Standard of Care in Patients with Niemann-Pick Disease Type C1.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
The company plans to begin a Phase III global pivotal clinical program later this year for treatment of NPC by intravenous administration of Trappsol® Cyclo™, the company’s proprietary formulation of hydroxypropyl beta cyclodextrin.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Novit LP
Deal Size: $2.8 million Upfront Cash: Undisclosed
Deal Type: Private Placement August 27, 2020
Details:
The presentations describe top line results from the Phase I trial, which is now closed, and interim results from the Phase I/II trial which is expected to be completed in early 2021.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Trappsol Cyclo
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 09, 2020
Details:
The final report to FDA states that the drug showed a favorable safety profile as well as encouraging observations of benefit. Safety was monitored by MRIs, ECGs, laboratory safety assessments, and adverse events, all of which supported a favorable safety profile.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol Cyclo
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2020
Details:
EMA’s Committee for Orphan Medicinal Products concluded that the currently proposed clinical development is sufficient to demonstrate significant benefit of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
The patent application describes treating Alzheimer’s Disease with the Company’s Trappsol® Cyclo™ hydroxypropyl beta cyclodextrin product.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Neurology Product Name: Trappsol Cyclo
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 14, 2020
Details:
The financing brings additional capital resources to the development of Cyclo's lead drug candidate, Trappsol® Cyclo™, as an intravenous treatment for Niemann-Pick Disease Type C.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement April 27, 2020
Details:
The Committee evaluated all safety data in a blinded fashion from the Phase I trial in Patients With Niemann-Pick Disease Type C and the Effects of Dosing Upon Biomarkers of NPC Disease.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
Details:
The Company has reported previously on blinded data from its Phase I and Phase I/II trials showing the positive safety profile of the drug.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2020
Details:
All eligible patients who completed the Phase I trial entered the Extension Protocol, an important signal of how patients perceive benefits of receiving Trappsol® Cyclo™ intravenously.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 26, 2020
Details:
Data from the current study combined with those of the companion Phase I study will be used to inform the design of the Phase III global pivotal trial.
Lead Product(s): Hydroxypropyl-Beta Cyclodextrin
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 20, 2020
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