Cyclo Therapeutics Announces Notice of Decision to Grant European Patent Application for Treatment of Alzheimer’s Disease from European Patent Office

Rhea-AI Summary

Cyclo Therapeutics (Nasdaq: CYTH) has received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, 'Methods for Treating Alzheimer's Disease' under European patent number 3873604B. The patent will take effect on August 21, 2024.

CEO N. Scott Fine emphasized the importance of this milestone for the company's Alzheimer's disease asset and overall patent portfolio. Cyclo Therapeutics is developing Trappsol® Cyclo™, an orphan drug designated product, which is currently the subject of four formal clinical trials for Niemann-Pick Disease Type C and a Phase 2b clinical trial for early Alzheimer's disease.

Positive

• Received notice of decision to grant European patent for Alzheimer's disease treatment
• Patent strengthens company's intellectual property portfolio
• Trappsol® Cyclo™ in Phase 2b clinical trial for early Alzheimer's disease
• Trappsol® Cyclo™ designated as orphan drug in US and Europe

Negative

• None.

Biotechnology Patent Analyst

The European Patent Office's decision to grant Cyclo Therapeutics' patent application for "Methods for Treating Alzheimer's Disease" is a significant development for the company's intellectual property portfolio. This patent, set to take effect on August 21, 2024, strengthens Cyclo Therapeutics' position in the competitive Alzheimer's disease treatment landscape.

The granted patent likely covers the use of Trappsol® Cyclo™, the company's lead candidate, for Alzheimer's treatment. This intellectual property protection in Europe could provide Cyclo Therapeutics with a competitive advantage and potentially increase the asset's value for partnerships or licensing opportunities.

However, it's important to note that while patent protection is valuable, it doesn't guarantee clinical success or market approval. The company is currently conducting a Phase 2b trial for Trappsol® Cyclo™ in early Alzheimer's disease (NCT05607615). The outcome of this trial will be far more critical in determining the asset's true potential and market value.

Investors should also consider that Alzheimer's disease drug development has a historically high failure rate. Even with patent protection, Cyclo Therapeutics faces significant challenges in bringing a successful treatment to market. The company's financial resources and ability to fund ongoing clinical development will be important factors to monitor.

Neuroscience Research Analyst

Cyclo Therapeutics' approach to Alzheimer's disease treatment with Trappsol® Cyclo™ is intriguing from a scientific perspective. The company's strategy appears to be based on the potential link between cholesterol metabolism and Alzheimer's pathology, which has gained traction in recent years.

Trappsol® Cyclo™, a hydroxypropyl beta cyclodextrin, has shown promise in Niemann-Pick Disease Type C, a rare genetic disorder characterized by cholesterol accumulation in cells. The company's hypothesis that this approach could also benefit Alzheimer's patients is scientifically plausible, given the growing evidence of cholesterol's role in amyloid-beta accumulation and neuroinflammation in Alzheimer's disease.

However, it's important to note that many promising Alzheimer's treatments have failed in later-stage trials. The complexity of the disease and the challenge of translating preclinical success to human efficacy remain significant hurdles. The ongoing Phase 2b trial (NCT05607615) will be important in validating this approach.

Investors should be aware that while the scientific rationale is sound, the path to a successful Alzheimer's treatment remains highly uncertain. The results of the Phase 2b trial, particularly any biomarker data indicating effects on amyloid-beta or tau pathology, will be critical in assessing the potential of Trappsol® Cyclo™ in Alzheimer's disease.

GAINESVILLE, Fla.--(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 the Company received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, “Methods for Treating Alzheimer’s Disease” under European patent number 3873604B. The notice states that mention of the decision will be published on August 21, 2024 in European Patent Bulletin 24/34 and will take effect on that date.

N. Scott Fine, CEO of Cyclo Therapeutics, commented, “This notice of decision to grant the European patent application represents an important milestone for our Alzheimer’s disease asset as well as a valuable component of our patent estate. With the desperate need for innovation and therapeutic solutions to treat early onset Alzheimer’s disease, we remain hopeful in the potential for Cyclo Therapeutics’ Trappsol^® Cyclo™ to play a significant role in the treatment armamentarium.”

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 living with 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 conducting a Phase 2b clinical trial using Trappsol^® Cyclo™ intravenously in early Alzheimer’s disease (NCT05607615) based on encouraging data from an Expanded Access program for 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240729808059/en/

Investor Contact:

JTC Team, LLC

Jenene Thomas

(833) 475-8247

CYTH@jtcir.com

Source: Cyclo Therapeutics, Inc.

FAQ

What European patent did Cyclo Therapeutics (CYTH) receive notice for?

Cyclo Therapeutics received notice of a decision to grant European patent application No. 19805439.7 titled 'Methods for Treating Alzheimer's Disease' under European patent number 3873604B.

When will Cyclo Therapeutics' (CYTH) new European patent take effect?

The European patent for Cyclo Therapeutics' Alzheimer's disease treatment method will take effect on August 21, 2024.

What clinical trials is Cyclo Therapeutics (CYTH) currently conducting?

Cyclo Therapeutics is conducting four formal clinical trials for Niemann-Pick Disease Type C and a Phase 2b clinical trial for early Alzheimer's disease using their product Trappsol® Cyclo™.

What is the main product Cyclo Therapeutics (CYTH) is developing?

Cyclo Therapeutics is developing Trappsol® Cyclo™, an orphan drug designated product in the United States and Europe, for various indications including Niemann-Pick Disease Type C and Alzheimer's disease.