Cyclo Therapeutics Announces Positive Outcome From Type C Meeting With FDA

(RTTNews) - Clinical stage biotechnology company, Cyclo Therapeutics, Inc. (CYTH), Monday announced positive outcome from type C meeting with FDA about the company's Trappsol Cyclo clinical development program for the treatment of Niemann-Pick disease Type C1.

Niemann-Pick disease is a rare, inherited disease which affects the body's ability to metabolize fats.

The meeting with FDA was held on December 14, to discuss a full data review of the company's Trappsol Cyclo clinical development program to date and proposed strategies for the statistical analysis for the ongoing pivotal Phase 3 study, TransportNPC.

During the discussion, the company's clinical data NCT02939547, NCT03893071 and NCT02912793 were reviewed and based on that, FDA allowed the company to proceed with Phase 3 96-week study under which the company plans to enroll at least 93 pediatric (age 3 years and older) and adult patients with NPC1.

The Company's ongoing TransportNPC study is a randomized, double-blind, placebo-controlled, parallel group, multicenter study designed to evaluate the safety, tolerability, and efficacy of 2,000 mg/kg doses of Trappsol Cyclo administered intravenously and standard of care (SOC).

The company received Orphan Drug Designation for Trappsol Cyclo to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S, the company said in a statement.

Currently, shares of Cyclo Therapeutics are moving down 2.92%, to $1.33 on the Nasdaq.