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Appetite regulation

Positive results for probiotic Hafnia alvei HA4597 on the weight loss

Preclinical studies on Hafnia alvei HA4597 have demonstrated anti-obesity effects such as weight loss, fat mass reduction, reduced food intake and positive effects on blood sugar and insulin resistance

TargEDys has completion of its three months, randomised, double blind, placebo-controlled, multi-centre clinical study carried out on 229 subjects and evaluating the efficacy of Hafnia alvei HA4597 in the weight loss by regulation of the appetite. The company, 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.

"These results show a significant efficacy after already two months and which is reinforced at three months,” said Pierre Déchelotte, co-founder and Clinical Advisor. “The mechanism of action that had been described during the preclinical studies is confirmed.”

Preclinical studies on Hafnia alvei HA4597 have demonstrated anti-obesity effects such as weight loss, fat mass reduction, reduced food intake and positive effects on blood sugar and insulin resistance.

The study was carried on overweight subjects (BMI 25-30). 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 favour of the probiotic in the proportion of subjects who lost at least 3% of their body weight at 12 weeks. Secondary endpoints included the proposed mechanism of action is confirmed by a statistically significant increase in the feeling of fullness and that the probiotic effect is also higher than the placebo in the reduction of hip circumference.

The outcomes showed that 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 was shown to be superior to the placebo through the overall evaluation of the benefits perceived by both the investigating physicians and the subjects.

"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,” said Gregory Lambert, CEO and vice-president of Research and Development in TargEDys.

"The success of this clinical trial is a turning point for TargEDys,” said Jean-Frederic Laville, newly appointed Chief Business Officer. “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.”

The study results will be the subject of a scientific publication.

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