French Biotech TargEDys(R) Announces Positive Results of Its Clinical Trial With Its Probiotic Strain Hafnia alvei HA4597(TM) on the Weight Loss Thanks to Regulation of Appetite

PR82747

PARIS, Feb. 6, 2020 /PRNewswire=KYODO JBN/ --

TargEDys(R) 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(R) 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 á- 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(R) 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[2].

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 Dechelotte, co-founder and Clinical Advisor.

According to Gregory Lambert, CEO and vice-president of Research and

Development in TargEDys(R), "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(R). 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.

About TargEDys(R)

TargEDys(R) 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 Dechelotte and Serguei 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 Gregory 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.

Additional information: http://www.targedys.com

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Press contact:

LJ Communication

Helene BLEHER / Sabrina OULMAS

(+33)-01-45-03-57-66 / (+33)-01-45-03-50-32

h.bleher@ljcom.net / s.oulmas@ljcom.net

Source: TargEDys