French R&D company Valbiotis has reported positive results from a Phase I/II study of VAL 070 for the treatment of patients with hypercholesterolemia.
The randomised, placebo-controlled, double-blind trial was conducted in France on 40 patients aged 18 to 70 with mild-to-moderate hypertriglyceridemia and hypercholesterolemia, who are not currently undergoing any treatment with hypolipidemic drugs.
During the trial, the patients were divided into three groups to receive VAL 070, placebo and phytosterols over a course of 12 weeks without any modifications to their regular diet or physical activity.
One of the groups enrolled ten subjects to receive placebo.
The two remaining groups included 15 subjects each to receive a 3.5g daily dose of VAL-070, and 3.5g/day of VAL-070 in combination with a 1.5g daily dose of phytosterols, respectively.
The trial’s goals were to confirm the safety and tolerance, establish the primary endpoint for the Phase II studies and to assess the benefit of VAL-070 compared to phytosterols.
In the subjects receiving VAL-070, alone or in combination with phytosterols, the study observed an average reduction of around 7% in blood LDL-cholesterol levels from baseline to the end of the study within the two groups.
Furthermore, Valbiotis reported that the haemodynamic, hepatic and renal parameters showed that VAL-070 has a favourable safety profile. No adverse events were observed during the course of the study.
The study did not plan to achieve any statistical significance.
Valbiotis CEO Sébastien Peltier said: “These results represent a key milestone in the clinical development of VAL-070 and its potential to address hypercholesterolemia, a public health issue that represents a major risk factor for cardiovascular diseases.
“VAL-070 has the potential to become a first-line option that differentiates from currently marketed dietary supplements: plant sterols and stanols or red yeast rice.”
Valbiotis said that it intends to begin a Phase II registration study during the first half of next year to evaluate VAL-070 in patients with mild-to-moderate hypercholesterolemia.