PARIS, Feb. 6, 2020 /PRNewswire/ -- 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(TM) 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(TM) can produce a protein (ClpB) which is a mimetic of the satiety hormone - MSH hence it is able to influence the mechanisms of appetite control at the peripheral and central level. Preclinical studies on Hafnia alvei HA4597(TM) 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(TM) 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(TM) had an effect on cholesterol levels and induced a higher decrease in glycemia than the one observed with the placebo. Finally, Hafnia alvei HA4597(TM) 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(TM)," said Jean-Frederic Laville, newly appointed Chief Business Officer.
The study results will be the subject of a scientific publication.
TargEDys® is a commercial stage French biotech, specialized in the development of nutraceutical and therapeutic solutions for appetite regulation and weight management via microbiome interventions. Founded by Professors Pierre Déchelotte and Sergueï Fetissov, the company is the result of many years of academic research on microbiome-gut-brain axis conducted by INSERM laboratories of the University of Rouen Normandy and the University Hospital of Rouen. Led by Grégory Lambert, the company has developed and commercializes its first product based on alpha-MSH mimicry technology, ProbioSatys(TM). This technology uses the probiotic strain Hafnia alvei HA4597(TM) which efficacy is clinically proven in weight loss and appetite regulation. The company develops a portfolio of products targeting overweight as well as malnutrition and cachexia.
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