Cyclo Therapeutics Presents Positive Preliminary Phase 3 Data from Ongoing TransportNPC Open-Label Sub-Study

February 7, 2025

DENVER, Colo., Feb 07, 2025 (247marketnews.com)- Cyclo Therapeutics (NASDAQ:CYTH) reportedly made significant progress in its ongoing Phase 3 TransportNPC study. The study is evaluating Trappsol Cyclo for the treatment of Niemann-Pick Disease Type C1 (NPC1). The company recently presented data from the study at the 21st Annual WORLD Symposium in San Diego, CA.

Scott Fine, CEO of Cyclo Therapeutics, said, “We continue to be encouraged by the data demonstrated by Trappsol Cyclo in the treatment of NPC. The growing body of data from our TransportNPC study and sub-study continue to demonstrate the potential of Trappsol Cyclo to address a devastating disease with significant unmet need. We look forward to our interim data readout from the TransportNPC study, which is expected in H1 2025 and ultimately providing a much needed treatment option for patients.”

The presentation’s key highlights include the following. TransportNPC is the most comprehensive pivotal study for NPC1 to date in terms of patient size, global scope, study duration, and clinical outcomes. The study completed its enrollment in May 2024, and includes a sub-study that focuses on treating newborns to 3-year-old children. This sub-study is examining the potential of Trappsol Cyclo to provide early intervention for NPC1 and possibly prevent disease progression. The sub-study is being conducted outside of the U.S. under the company’s Pediatric Investigational Plan (PIP).

The key data highlights include that the earlier Phase 1 study demonstrated clearance of lipids, centrally and systemically, in adult NPC patients, showcasing the potential efficacy of Trappsol Cyclo. Patients in the sub-study had a range of disease severity (from mild to severe). Some promising clinical improvements have been seen, especially in patients with mild to moderate disease.

7 of 8 patients who reached 24 weeks and 6 of 7 who reached 48 weeks showed stabilization or improvement on the Clinical Global Impression – Change (CGI-C) scale.

The safety profile of Trappsol Cyclo is consistent with earlier studies. A total of 107 adverse events (AEs) were reported as of December 2024. Most of these were mild (77%) or moderate (22%), with only one severe AE. Only one mild AE was possibly related to the study drug.

Serious AEs (SAEs): Out of the 107 reported AEs, 19 were considered serious, but none were linked to the study drug.

Dr. Caroline Hastings presented two posters at the WORLD Symposium. The first poster was on long-term treatment with Trappsol Cyclo across four clinical studies and the ongoing Expanded Access Program. The second covered the efficacy across individual 5D domains and the use of future assessment tools for NPC.

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