Golden Biotechnology Corp. (TW4132) completed a non-oncology trial, the Phase 2 clinical trial of Antroquinonol® in the treatment of hypercholesterolemia and hyperlipidemia which was kick-off in 2015 in Taiwan. It was a double-blind clinical study. The trial has been finished by August and decoded in September 2018 with the success of meeting the targets after unblinding of clinical data.
Official title of this trial was “A Prospective, Double Blind, Randomized, Placebo-controlled Trial of Antroquinonol in Patients with Hypercholesterolemia and Hyperlipidemia.”
The primary efficacy objective of the trial is to demonstrate the reduction of triglyceride (TG) by Antroquinonol, in comparison with placebo, after 12 weeks of treatment in patients with hypercholesterolemia and hyperlipidemia. Secondary objectives include the evaluation of the effects of Antroquinonol in comparison with placebo on other lipid parameters after 12 weeks of treatment and the effects of Antroquinonol on left ventricular diastolic function, arterial stiffness and fatty liver. The safety and tolerability of Antroquinonol was monitored as well.
The main observational indicator was the blood changes in the subject for Triglyceride (TG). The results showed that patients taking Hocena (Antroquinonol) significantly reduced the level of triglyceride value in the blood.
For secondary observation indicators such as: (a) arteriosclerosis index (arm brachial wave propagation rate, baPWV) (b) fatty liver parameter changes (3) Low-density lipoprotein cholesterol (LDL-C) all had statistically significant effects. Other blood lipid parameters such as total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and LDL/HDL ratios all showed an improvement trend. This clinical trial is the first of Golden Biotechnology Corp.to demonstrate the effectiveness of the new drug, Hocena (Antroquinonol), in the development of chronic diseases in humans. In addition to providing evidence of efficacy in blood lipid control, it also accumulates the safety data for the new drug in human use. , laying the foundation for success in the development of subsequent relevant clinical indications.