French research and development company Valbiotis’ prediabetes product Valedia (TOTUM-63) significantly decreased blood glucose levels according to top-line results from a Phase IIa clinical trial.
TOTUM-63, the active substance of Valedia, combines five plant extracts that synergistically target physiopathological mechanisms of type 2 diabetes.
The drug is intended to minimise the risk of developing type 2 diabetes in the prediabetes population.
During the randomised, double-blind, placebo-controlled, multi-centre Phase IIa trial, a daily dose of 5g Valedia was compared to placebo over six months.
The study enrolled participants who had moderate hyperglycaemia, hyperglycaemia two hours following glucose dose, abdominal obesity, and hypertriglyceridemia.
Findings showed that the drug led to a reduction in both fasting and post-prandial glucose levels, thereby meeting the primary and secondary endpoints of the trial, respectively.
In addition, significant reductions were observed in body weight and waist circumference.
Commenting on the study results, Valbiotis CEO Sébastien Peltier said: “They demonstrate that TOTUM-63, the active substance of Valedia, reduces the two main risk factors for type 2 diabetes in people with prediabetes.
“This is a critical milestone for Valbiotis, we have now scientifically validated in humans the efficacy of our new plant-based approach to prevent metabolic diseases.”
This positive Phase IIa data facilitates the concomitant initiation of two Phase IIb trials, REVERSE-IT and PREVENT-IT. The new studies are intended to support the health claims in Europe and North America for type 2 diabetes risk reduction.
A previous Phase I/II trial in healthy volunteers demonstrated a favourable safety and tolerability profile for TOTUM-63. Valbiotis noted that the regulatory process for Valedia does not require a Phase III trial.
The company expects to commercially launch the prediabetes product in 2021.