TargEDys® announces the successful completion of its 3 months, randomized, double blind, placebo-controlled, multicentric clinical study carried out on 229 subjects and evaluating the efficacy of Hafnia alvei HA4597™ in the weight loss by regulation of the appetite.
TargEDys® in partnership with the University of Rouen Normandy, the University Hospital of Rouen and INSERM discovered that enterobacteria such as Hafnia alvei HA4597™ can produce a protein (ClpB) which is a mimetic of the satiety hormone α- MSH hence it is able to influence the mechanisms of appetite control at the peripheral and central level. Preclinical studies on Hafnia alvei HA4597™ have demonstrated anti-obesity effects such as weight loss, fat mass reduction as well as a reduced food intake and positive effects on blood sugar and insulin resistance.
TargEDys® has just confirmed clinically these pre-clinical data. The study was carried on overweight subjects characterized by a body mass index between 25 and 30 kg/m. The two arms underwent a hypocaloric diet associated either with the Hafnia alvei HA4597™ probiotic or with a placebo. The primary endpoint related to weight loss has been achieved: there is a statistically significant difference in favor of the probiotic in the proportion of subjects who lost at least 3% of their body weight at 12 weeks. Amongst other secondary endpoints, the proposed mechanism of action is confirmed by a statistically significant increase in the feeling of fullness. Furthermore, the probiotic effect is also higher than the placebo in the reduction of hip circumference. Only the Hafnia alvei HA4597™ had an effect on cholesterol levels and induced a higher decrease in glycemia than the one observed with the placebo. Finally, Hafnia alvei HA4597™ has shown to be superior to the placebo through the overall evaluation of the benefits perceived by both the investigating physicians and the subjects.
“These results show a significant efficacy after already 2 months and which is reinforced at 3 months. The mechanism of action that had been described during the pre-clinical studies is confirmed,”
comments Pierre Déchelotte, co-founder and Clinical Advisor.
According to Gregory Lambert, CEO and vice-president of Research and Development in TargEDys®,
“It is the first product of a new generation of probiotics, single strain, endowed with a scientifically established mechanism of action in the microbiome-gut-brain axis and with a proven short-term clinical efficacy.”
“The success of this clinical trial is a turning point for TargEDys®. The clinical confirmation of all pre-clinical findings will boost the international commercial deployment of our network of partners for the commercialization of our unique nutritional solution, already sold in France under the name EnteroSatys™,” said Jean-Frederic Laville, newly appointed Chief Business Officer.
The study results will be the subject of a scientific publication.