- VALEDIA® significantly reduced blood glucose levels, and body
weight compared to placebo (topline data, published on 3 July
20191).
- VALEDIA® also significantly reduced, compared to placebo :
- Blood triglyceride levels by 32.2% ;
- Fatty liver index (accumulation of fat in the liver) by 18.7%
;
- Arterial hypertension by 10.6 mmHg, and 18.9 mmHg in
hypertensive people ;
- Blood LDL cholesterol levels by 11.7%.
- The results of Phase IIA study have exceeded all set objectives
and the overall efficacy of VALEDIA® in subjects at risk of
metabolic diseases has been proven.
Regulatory News:
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the full release here:
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VALBIOTIS pipeline (Graphic:
VALBIOTIS)
VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME
eligible), a Research & Development company committed to
scientific innovation for preventing and combating metabolic
diseases, today announced additional positive results from its
Phase IIA clinical study2 of VALEDIA® on four parameters which were
among the secondary endpoints of the study: blood triglyceride
levels, Fatty Liver Index, (fat accumulation in the liver), blood
LDL cholesterol levels, and arterial hypertension.
Topline data from the study were published on 3 July 20191,
which showed a significant reduction in hyperglycemia, body weight
and waist size compared to placebo. The entire Phase IIA clinical
study has therefore demonstrated the efficacy of VALEDIA® on
various abnormalities in carbohydrate and lipid metabolism.
Professor Jean-Marie BARD, Hospital Practitionner and Professor
of Fundamental and Clinical Biochemistry at the University of
Nantes, scientific expert for the study, commented, "The full
results clearly demonstrate a positive effect on the entire
clinical profile: hyperglycemia, hypertriglyceridemia, hepatic
steatosis, overweight and abdominal obesity, hypercholesterolemia
and arterial hypertension. These risk factors, contribute to an
increased risk of type 2 diabetes, cardiovascular disease and liver
diseases such as NASH."
Murielle CAZAUBIEL, Director of Development and Medical Affairs,
and member of the VALBIOTIS Executive Board, explained, "Today, we
are presenting very compelling data which demonstrates the global
efficacy of TOTUM-63, active substance of VALEDIA® and its action
on the metabolic profile as a whole. This is excellent news for our
priority to reduce the risk of type 2 diabetes in prediabetic
patients.
We will soon be launching two concurrent Phase IIB studies in
prediabetic patients (last studies), as announced previously. Our
medium-term strategy is also clear: the significant lipid-lowering
effect of VALEDIA® bodes extremely well for the reduction of
non-alcoholic fatty liver, a risk condition for developing NASH.
This will be the main focus of another Phase IIB clinical study.
These results have opened up new opportunities for TOTUM-63 in the
future, in the field of hypertension, for example."
Additional results from the Phase IIA clinical study of
VALEDIA® in lipid metabolism and arterial hypertension
The international Phase IIA clinical study evaluated the
efficacy of VALEDIA® on carbohydrate and lipid metabolism. The
subjects included presented with prediabetes, abdominal obesity and
hypertriglyceridemia, which were not treated according to current
guidelines, as well as a high fatty liver index and high blood
pressure. Hypoglycemic, lipid-lowering or hypotensive treatments
were excluded. Lipid and hypertension parameters were secondary
criteria in the study.
Methodology
This was a multicenter, randomized, placebo-controlled,
double-blind study. Subjects received a daily dose of 5 grams of
VALEDIA®, compared to 5 grams of placebo for subjects in the
control group, over a 6-month period. Diet and physical activity
levels remained the same throughout the study in both groups.
Analyses were based on 51 subjects, 13 in the placebo group and 38
in the VALEDIA® group.
Characteristics of participants at the beginning of the
study
35 women, 16 men; average age: 57.1 years.
Average value of
participants at the beginning of the study
(baseline)
Maximum values
recommended for adults
Body Mass Index (BMI)
31.3 kg/m2
25 kg/m2 (overweight
threshold)
Glycemic parameters
- Fasting blood glucose
1.26 g/L
1.00 g/L (prediabetes
threshold*)
- Blood glucose level at 2 hours
(OGTT)
1.85 g/L
1.40 g/L (prediabetes
threshold)
Lipid parameters
- Fasting triglycerides
1.78 g/L
1.50 g/L (men) and 1.20 g/L
(women)
- Fatty Liver Index
73.34
60 (threshold for very high
probability of steatosis)
Systolic blood pressure
131 mmHg
130 mmHg (in the case of
metabolic syndrome) or 140 mmHg
*According to the American Diabetes Association (1.10 g/L
according to the WHO)
Results in lipid metabolism:
VALEDIA® significantly reduced two metabolic parameters for
lipids, compared to placebo: triglyceridemia (p< 0.01) and Fatty
Liver Index (p<0.001).
Triglycerides
Variation at 6 months
(g/L)
Variation of VALEDIA® vs
placebo3
Placebo (n=13 subjects)
+ 0.15 (± 0.15)
- 32.2%
VALEDIA® (n=38 subjects)
- 0.31 (± 0.10)
Average values (± SEM)
Fatty liver index
Variation at 6 months
Variation of VALEDIA® vs
placebo3
Placebo (n=13 subjects)
+ 5.64 (± 3.06)
- 18.7%
VALEDIA® (n=38 subjects)
- 4.66 (± 1.51)
Average values (± SEM)
Compared to placebo, VALEDIA® also significantly reduced blood
LDL cholesterol levels (p<0.05).
LDL cholesterol
Variation at 6 months
Variation of VALEDIA® vs
placebo3
Placebo (n=13 subjects)
+ 0.08 (± 0.07)
- 11.7%
VALEDIA® (n=38 subjects)
- 0.07 (± 0.04)
Average values (± SEM)
Results in arterial hypertension:
Compared to placebo, VALEDIA® significantly reduced systolic
blood pressure (p<0.01) in the total study population.
Systolic blood
pressure
Variation at 6 months
(mmHg)
Variation of VALEDIA® vs
placebo4
Placebo (n=13 subjects)
+ 7.54 (± 3.29)
- 10.57 mmHg
VALEDIA® (n=38 subjects)
- 3.03 (± 1.23)
Average values (± SEM)
Additional analyses were conducted on a subgroup, involving all
subjects at the beginning of the study with systolic blood pressure
levels higher than 130 mmHg, the threshold for hypertension in
cases of metabolic syndrome. The difference in the changes measured
at the end of the study was significant (p <0.001) and reached
18.9 mmHg in favor of the VALEDIA® group (n = 18) compared to
placebo (n = 8).
Systolic blood
pressure
Variation at 6 months
(mmHg)
Variation of VALEDIA® vs
placebo4
Placebo (n=8 subjects)
+ 10.75 (± 4.31)
- 18.86 mmHg
VALEDIA® (n=18 subjects)
- 8.11 (± 2.62)
Average values (± SEM)
Sébastien PELTIER, CEO of VALBIOTIS concluded, "The additional
results from this Phase IIA clinical study have far exceeded our
expectations. This data demonstrates the efficacy of VALEDIA® for
its primary indication, the reduction of risk of developing type 2
diabetes in people with prediabetes. What's more, this study
demonstrates the comprehensive action of VALEDIA® on metabolic
syndrome. This is a major asset for VALBIOTIS, opening up new
prospects in promising markets, such as in the field of
non-alcoholic fatty liver or arterial hypertension, which will be a
major focus point for future developments. In terms of our
commercial strategy, these excellent results will naturally give
new impetus to our negotiations with potential partners".
About TOTUM-63, the active ingredient of VALEDIA®
Prediabetes is a growing public health problem worldwide, which
is recognized by international organizations such as the WHO, the
American Diabetes Association and the International Diabetes
Federation, among others. Without effective treatment, 70% to 90%
of prediabetic patients will develop type 2 diabetes.
VALEDIA® is the first clinically validated product specifically
designed to help prediabetics reduce their risk of developing type
2 diabetes. VALEDIA® is the only product that contains the active
ingredient TOTUM-63, a unique and patented combination of 5 plant
extracts that act in synergy to target the physiopathological
mechanisms of type 2 diabetes.
TOTUM-63 has already shown perfect tolerance and safety during a
Phase I/II clinical study conducted in healthy volunteers. The
results of the first international randomized, placebo-controlled
study showed that in patients with prediabetes, TOTUM-63 reduces
fasting blood glucose and blood glucose at 2 hours, two risk
factors of type 2 diabetes. In these subjects, who also presented
with hypertriglyceridemia and abdominal obesity, TOTUM-63
significantly reduced body weight, waist circumference, blood
triglycerides, Fatty Liver Index, blood cholesterol levels, and
arterial hypertension.
The published Phase IIA study results and all key information
about the Company are presented in an updated corporate
presentation, available at the following link:
www.valbiotis.com/documents/
ABOUT VALBIOTIS
VALBIOTIS is a Research & Development company committed to
scientific innovation for preventing and combating metabolic
diseases. Its products are made for major players in the health
care sector. VALBIOTIS particularly focuses on solutions to prevent
type 2 diabetes, NASH (nonalcoholic steatohepatitis), obesity and
cardiovascular diseases.
VALBIOTIS was founded in La Rochelle in early 2014 and has
formed numerous partnerships with top academic centers in France
and abroad, including La Rochelle University, the CNRS and Clermont
Auvergne University located in Clermont-Ferrand. These partnerships
have enabled VALBIOTIS to benefit from strong financial leverage,
particularly thanks to experts and technical partners who support
its projects. The Company has established three sites in France –
Périgny, La Rochelle (17) and Riom (63) – and an American office in
Boston (MA).
VALBIOTIS is a member of the "BPI Excellence" network and
received the "Innovative Company" status accorded by BPI France.
VALBIOTIS has also been awarded "Young Innovative Company" status
and has received major financial support from the European Union
for its research programs by obtaining support from the European
Regional Development Fund (ERDF). VALBIOTIS is a PEA-SME eligible
company.
Find out more about VALBIOTIS:
www.valbiotis.com
Name: VALBIOTIS ISIN code: FR0013254851
Mnemonic code: ALVAL
This press release contains forward-looking statements about
VALBIOTIS' objectives, based on rational hypotheses and the
information available to the company at the present time. However,
in no way does this constitute a guarantee of future performance,
and these projections can be reconsidered based on changes in
economic conditions and financial markets, as well as a certain
number of risks and doubts, including those described in the
VALBIOTIS core document, filed with the French Financial Markets
Regulator (AMF) on 31 July 2019 (application number R19-030). The
document is available on the Company’s website (www.valbiotis.com).
This press release, as well as the information contained herein,
does not constitute an offer to sell or subscribe to, or a
solicitation to purchase or subscribe to, VALBIOTIS' shares or
securities in any country.
1 VALBIOTIS published the methodology and "Topline" results for
the Phase IIA study in a press release on 3 July 2019:
https://www.valbiotis.com/app/uploads/2019/07/2019-06-21-PR_VALBIOTIS_PHASEIIA-VALEDIA.pdf
2 ID-RCB Number: 2016-A00484-47 3 Difference between averages of
individual variations expressed in % 4 Difference between averages
of individual variations
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VALBIOTIS CORPORATE COMMUNICATION Carole
Rocher / Marc Delaunay +33 5 46 28 62
58 medias@valbiotis.com
FINANCIAL COMMUNICATION ACTIFIN Stéphane
Ruiz +33 1 56 88 11 14 sruiz@actifin.fr
MEDIA RELATIONS MADIS PHILEO Guillaume
De Chamisso +33 6 85 91 32 56
guillaume.dechamisso@madisphileo.com
UNITED STATES SOLEBURY TROUT Rebecca
John / Patrick Till +1 646 378 2935
rjohn@troutgroup.com ptill@troutgroup.com
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