VALBIOTIS Announces Positive Results from First Phase I/II Clinical Study of VAL-070 in Hypercholesterolemia

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/SME eligible),
a French Research & Development company committed to scientific
innovation for preventing and combating metabolic diseases, today
announced positive results from a Phase I/II pilot study on VAL-070,
demonstrating that the product was safe and well-tolerated in subjects
with untreated mild to moderate dyslipidemia. These results obtained on
blood LDL-cholesterol support usage of this parameter as the primary
endpoint of the Phase II clinical development.

VAL-070 is a combination of four food plant extracts that acts on lipid
metabolism without the use of phytosterols or red yeast rice, with a
patent pending in 60 countries.

The randomized, placebo-controlled, double-blind Phase I/II clinical
study was conducted in France in accordance with Good Clinical
Practices. It was conducted on 40 male and female volunteers aged 18 to
70 years with mild to moderate hypertriglyceridemia and
hypercholesterolemia, who are not currently undergoing any treatment
with hypolipidemic drugs. Volunteers were divided into three groups,
receiving supplements over the course of 12 weeks, without any
modifications to diet or physical activity:

The objectives of the study were to validate safety and tolerance, to
establish the primary endpoint for the clinical development and to
evaluate the benefit of VAL-070 compared to phytosterols.

Hemodynamic, hepatic and renal parameters demonstrated that VAL-070 has
a favorable safety profile, and no adverse events were observed. In
volunteers receiving VAL-070, alone or in combination with phytosterols,
an average reduction of nearly 7% was observed in blood LDL-cholesterol
levels from baseline to the end of the study in the two groups. The
study was not designed to achieve statistical significance. These
results support future Phase II clinical studies of VAL-070, in which
blood LDL-cholesterol will be the primary endpoint.

“These results represent a key milestone in the clinical development
of VAL-070 and its potential to address hypercholesterolemia, a
public health issue that represents a major risk factor for
cardiovascular diseases,” commented Sébastien Peltier, CEO of
VALBIOTIS. “VAL-070 has the potential to become a first-line option
that differentiates from currently marketed dietary supplements: plant
sterols and stanols or red yeast rice. We continue to bolster and
diversify our pipeline of products to prevent cardio-metabolic diseases,
and look forward to providing updates on continued development of
VAL-070.”

VALBIOTIS plans to initiate a Phase II registration study during the
first half of 2019, as soon as the regulatory authorizations are
received. This will be an international, randomized, and controlled
study on a target population with mild to moderate hypercholesterolemia.
It will be statistically powered to demonstrate a significant reduction
in blood LDL-cholesterol levels.

VAL-070 is being developed for subjects with mild to moderate
hypercholesterolemia, with the aim of establishing a proprietary health
claim related to the reduction of blood LDL-cholesterol, of which
elevated levels are a risk factor for developing cardiovascular
diseases. VALBIOTIS plans to seek regulatory approval in the United
States, Europe and Canada (FDA**, EFSA and Health Canada).

For healthcare professionals, VAL-070 would offer an innovative
first-line treatment solution and clinical benefit to subjects with
moderate cardiovascular risk, with a favorable efficacy and safety
profile. For agri-food and pharmaceutical companies, VAL-070 could
provide a means of differentiating from existing dietary supplements,
being free of phytosterols and red yeast rice and with a proprietary
LDL-cholesterol lowering health claim.

Professor Jean-Marie Bard, University professor, Hospital
practitioner at CHU Nantes commented, “This pilot study
demonstrates the clinical benefit of VAL-070 to reduce LDL-cholesterol.
These results should be confirmed in later clinical development on the
final target population. This product has the potential to provide a new
option to subjects at moderate risk for cardiovascular diseases, for
whom a first-line medication is not systematically prescribed.”

Moderate hypercholesterolemia: a need for clinically-proven, non- pharmaceutical
products

Hypercholesterolemia affects almost 30% of the adult French2
and American3 populations, and constitutes one of the major
risk factors for atherosclerosis and cardiovascular diseases. The
beneficial effects of reducing LDL-cholesterol in the blood on
cardiovascular risk have been well established4: a reduction
in blood cholesterol levels of 10% leads to a 50% reduction in the risk
of heart diseases at 5 years5. In subjects with
hypercholesterolemia, treatment involves a lifestyle change and possibly
a medicinal prescription3. In France and the United States,
statin treatment from the onset is recommended for subjects at high risk
for cardiovascular diseases, according to the latest guidelines4,6.

According to the European Society of Cardiology and the European
Atherosclerosis Society, dietary supplements can be incorporated into
prevention strategies, if they have a proven positive effect on blood
lipid levels demonstrated in randomized, controlled clinical studies7.
Included among these dietary supplements, products developed to reduce
LDL-cholesterol in patients not eligible for treatments are today mainly
based on phytosterols, which carry a generic health claim1.
The market for these products is expected to reach a billion dollars by
20248. Red yeast rice is also considered to be an effective
agent but contains a natural statin, monacolin K. Its status as a
dietary supplement has thus been called into question by authorities.
For example, the marketing of this ingredient is prohibited in the
United States9, Belgium and Switzerland and is subject to
restrictions in some European Union countries10.

* European Food Safety Authority** Food and Drug Administration

ABOUT VALBIOTIS

VALBIOTIS is a French Research & Development company committed to
scientific innovation for preventing and combating metabolic diseases.
Its products are made for manufacturers in the agri-food and
pharmaceutical industries. 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 the La Rochelle University, the
CNRS and the Clermont Auvergne University located in Clermont-Ferrand,
where the company opened a second office. These partnerships have
enabled VALBIOTIS to benefit from strong financial leverage,
particularly thanks to experts and technical partners who support its
projects. 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)

Find out more about VALBIOTIS:http://valbiotis.com/LinkedinTwitter

Name: VALBIOTISISIN code: FR0013254851Mnemonic code: ALVAL

1 Commission Regulation (EU) no. 432/2012 of 16
May 2012 establishing a list of permitted health claims made on foods,
other than those referring to the reduction of disease risk and to
children’s development2 De Peretti C, Perel C, Chin F,
Tuppin P, Iliou MC, Vernay M, et al. Cholestérol LDL moyen et prévalence
de l’hypercholestérolémie LDL chez les adultes de 18 à 74 ans, étude
nationale nutrition santé (ENNS) 2006-2007, France métropolitaine. BEH
2013;(31):378-853 Center for disease control, 2018, www.cdc.gov/cholesterol/index.htm,
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, et al. Heart
disease and stroke statistics—2017 update: a report from the American
Heart Association. Circulation. 2017;135:e1–e458.4
ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce
Atherosclerotic Cardiovascular Risk in Adults, 20135 http://www.who.int/gho/ncd/risk_factors/cholesterol_text/en/6
US Preventive Services Task Force, Final Recommendation Statement,
Statin Use for the Primary Prevention of Cardiovascular Disease in
Adults: Preventive Medication, JAMA, Novembre 20167
Reiner Z, Catapano AL, De Backer G et al (2011) ESC/EAS Guidelines for
the management of dyslipidaemias: the Task Force for the management of
dyslipidaemias of the European Society of Cardiology (ESC) and the
European Atherosclerosis Society (EAS). Eur Heart J 32(14):1769–18188
https://www.gminsights.com/pressrelease/phytosterols-market-size9
National Center for Complementary and Integrative Health,https://nccih.nih.gov/health/redyeastrice10
Levure de riz rouge : déconseillée dans le cholestérol, Prescrire, 1er
Oct. 2016, http://www.prescrire.org/fr/3/31/52215/0/NewsDetails.aspx

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