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Cyclo Gets Positive Opinion From EMA Committee On Agreement Of PIP For Trappsol Cyclo; Stock Up

Cyclo Therapeutics Inc. (CYTH) said that it has received a positive opinion from the Paediatric Committee of the European Medicines Agency on its agreement with the proposed Paediatric Investigation Plan or PIP for Trappsol Cyclo, a proprietary formulation of hydroxypropyl beta cyclodextrin, used intravenously or IV, currently in development for the treatment of Niemann-Pick Type C or NPC1.

In Tuesday pre-market trading, CYTH was trading at $9.60 up $1.70 or 21.52%.

The PIP opinion from PDCO has endorsed the clinical program to evaluate the safety, tolerability and efficacy of Trappsol Cyclo in patients from 3 years to less than 18 years of age with NPC Type C1 as well as the inclusion of a single-arm sub-study with patients from birth to less than 3 years of age with NPC Type C1 to evaluate safety and obtain descriptive data on global severity and improvement in response to Trappsol Cyclo.

The company noted that the 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.

Cyclo Therapeutics would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval.

Cyclo Therapeutics has received Fast Track Designation for NPC from the U.S. Food and Drug Administration, along with Orphan Drug Designation for Trappsol Cyclo in both the U.S. and EU, and Rare Pediatric Disease Designation from the FDA. In addition, Trappsol Cyclo has the potential for Priority Review Voucher (PRV) in U.S.

NPC affects every cell in the body due to a defect in the NPC1 protein which is responsible for cholesterol processing in the cell.

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