Rafael Holdings Inc. Announces Continuation of Phase 3 TransportNPC Study for Trappsol® Cyclo™ Following Positive Interim Analysis

Reuters
06-18
Rafael Holdings Inc. Announces Continuation of Phase 3 TransportNPC Study for Trappsol® Cyclo™ Following Positive Interim Analysis

NEWARK, NJ - June 18, 2025 (GLOBE NEWSWIRE) - Rafael Holdings, Inc. (NYSE: RFL; NYSE American: RFL-WT) announced the continuation of its subsidiary Cyclo Therapeutics' 96-week pivotal phase 3 TransportNPC study. This study evaluates the intravenous (IV) Trappsol® Cyclo™ for the potential treatment of Niemann-Pick Disease Type C1 (NPC1). The decision to proceed was based on the independent Data Monitoring Committee's $(DMC.AU)$ review of safety and efficacy data at the prespecified 48-week interim analysis. The FDA has accepted the statistical analysis plan for the study, indicating progress in the clinical development phase. The study aims to explore the potential of Trappsol® Cyclo™ as a treatment option in addressing the root cause of NPC1. The continuation to 96 weeks reflects the ongoing commitment to assessing the investigational candidate's systemic and neurological treatment potential. Results of the interim analysis have been presented, and further results will be available upon completion of the study.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Rafael Holdings Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001213900-25-055402), on June 18, 2025, and is solely responsible for the information contained therein.

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