Gordagen Pharmaceuticals announced on Tuesday results for the first part of its Phase I clinical trial of a Single Ascending Dose Pharmacokinetics study.
The company is preparing the trial results for publication. The study assessed the company's "melt-then-swallow" technology (MELT3), a formulation based on annatto-derived tocotrienols.
"The successful completion of this first part of the Phase I clinical trial is a major milestone in our product development program for evidence-based nutraceuticals,” Glenn Tong, Gordagen's managing director and CEO, said. “Results from this recent trial provide strong support for the benefits of our MELT3 tablets as a new proprietary and patent-pending tocotrienol formulation that is close to commercial launch in the United States, and also demonstrate safety and tolerability among healthy volunteers.”
The study confirmed that the MELT3 (melt-then-swallow) formulation has good bioavailability with good plasma levels achieved.
There are Multiple Ascending Dose PK study and Phase II efficacy studies planned for late 2015 and 2016 that will also provide additional information with regard to an effective dosing regimen.
“The results from this part of Gordagen's Phase I clinical trial indicates that the MELT3 product is very promising indeed and lays a solid foundation for both the second part of the Phase I clinic trial, the Multiple Ascending Dose PK study, and also the Phase II clinical studies for muscle recovery and exercise endurance," Ric DeGaris, COO for Gordagen, said.