Business Wire

VALBIOTIS Announces Positive Results From the Phase IIA Clinical Study of VALEDIA®, Now the First Product Proven Effective in People With Prediabetes

Share

Regulatory News:

VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / PEA/PME eligible), Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, today announced positive results (topline data) for the Phase IIA study1 of VALEDIA® (active substance: TOTUM-63), which evaluated this product's efficacy in a prediabetic population, compared to placebo. In this population, VALEDIA® significantly reduced fasting and post-prandial blood glucose levels, the two main risk factors for type 2 diabetes and the primary and secondary endpoints of the study, respectively. VALEDIA® also significantly reduced body weight and waist circumference. Thanks to these results, VALEDIA® is the first clinically validated product designed for prediabetic people, to reduce several risk factors for type 2 diabetes. These results enable the concomitant launch of the last two Phase IIB clinical studies (REVERSE-IT and PREVENT-IT), to obtain the first health claims for the risk reduction of type 2 diabetes in Europe and North America. This regulatory process does not require a Phase III study. Commercialization is planned for 2021, as previously announced.

Professor Jean-Marie BARD, Hospital Practitioner and Professor of Fundamental and Clinical Biochemistry at the University of Nantes, scientific expert for the study comments, "The reduction of fasting blood glucose and blood glucose 2 hours after a glucose intake is a new advance for prediabetics. These results show the impact of VALEDIA® on metabolism, with even a decrease in body weight and waist circumference, usually hard to demonstrate in clinical studies. With such data, VALEDIA® proves its efficacy to reduce type 2 diabetes risk factors.“

Murielle CAZAUBIEL, member of the board and Director of Development and Medical Affairs at VALBIOTIS, adds: "VALEDIA® was designed to carry out multiple actions on several metabolic targets, thanks to an original plant-based composition. This innovation has had clinical success in people with prediabetes: we now know that VALEDIA® acts on risk factors for type 2 diabetes. This study is a great success, and we'd like to express our thanks to all the volunteers who participated."

Main results of the VALEDIA® Phase IIA clinical study in prediabetic people

This multicenter study, conducted in Europe, evaluated TOTUM-63, the active ingredient of VALEDIA®, in prediabetic people for 6 months. It was a randomized, double-blind, placebo-controlled study. Included subjects received a daily dose of 5 grams of VALEDIA® while the control group received 5 grams of the placebo. Dietary habits and physical activity levels remained unchanged in both groups during the study. The inclusion criteria were strict to ensure the robustness of the study: the subjects had to have moderate hyperglycemia, hyperglycemia 2 hours after glucose dose (OGTT, Oral Glucose Tolerance Test), abdominal obesity and hypertriglyceridemia. With such characteristics, the included subjects were particularly at risk of fast and pejorative evolution. Analyses were conducted on 51 subjects, 13 in the placebo group and 38 in the VALEDIA® group, according to the unbalanced study design.

Main characteristics of the study population:
Age:
57.1 years old
Gender: 35 women and 16 men
Body Mass Index: 31.3 Kg/m2
Fasting glycemia: 1.26 g/L
2h-glycemia (OGTT): 1.85 g/L
Blood triglycerides: 1.78 g/L

• Main criterion met:

VALEDIA ® significantly reduced fasting blood glucose levels, compared to the placebo, after 6 months (p<0.05).

 

Fasting glycemia (g/L)

 

6 months variation (g/L)

Variation VALEDIA®
vs placebo 2

Placebo (n=13 subjects)

+ 0.09 (± 0.04)

- 9.3%

VALEDIA® (n=38 subjects)

- 0.04 (± 0.02)

 

Mean values (± SEM)

 

Moderate fasting hyperglycemia is the main risk factor for type 2 diabetes identified in people with prediabetes. With these results, VALBIOTIS defines the reduction of fasting blood glucose levels as the primary endpoint of the last two clinical studies that will be used to support requests for health claims in Europe, the United States and Canada.

• Secondary criteria met:

VALEDIA® significantly reduces blood glucose levels after 2 hours (post-prandial blood glucose), the second risk factor for type 2 diabetes, compared to the placebo (p<0.05).

 

2 hours OGTT glycemia (g/L)

 

6 months variation (g/L)

Variation VALEDIA®
vs placebo 2

Placebo (n=13 subjects)

+ 0.32 (± 0.17)

- 22.5%

VALEDIA® (n=38 subjects)

- 0.02 (± 0.07)

 

Mean values (± SEM)

 

VALEDIA® significantly reduced two anthropometric parameters, compared to the placebo: body weight (p< 0.05) and waist circumference (p< 0.001).

 

Body weight (Kg)

 

6 months variation (g/L)

Variation VALEDIA®
vs placebo 3

Placebo (n=13 subjects)

+ 1.83 (± 0.57)

- 1.9 Kg

VALEDIA® (n=38 subjects)

- 0.07 (± 0.42)

 

Mean values (± SEM)

 

 

Waist circumference (cm)

 

6 months variation (cm)

Variation VALEDIA®
vs placebo 3

Placebo (n=13 subjects)

+ 2.81 (± 0.65)

- 4.48 cm

VALEDIA® (n=38 subjects)

- 1.67 (± 0.73)

 

Mean values (± SEM)

 

Furthermore, safety data confirm that this plant-based product achieves perfect tolerance.

For Sébastien PELTIER, CEO of VALBIOTIS "The results of this clinical Phase IIA study exceed our expectations. They demonstrate that TOTUM-63, the active substance of VALEDIA®, reduces the two main risk factors for type 2 diabetes in people with prediabetes. This success validates the concomitant launch of the last two clinical studies for VALEDIA® to obtain the first health claims for the risk reduction of type 2 diabetes, in Europe and in North America. This major milestone strengthens our discussions with potential partners for marketing VALEDIA®. This is a critical milestone for VALBIOTIS: we have now scientifically validated in humans the efficacy of our new plant-based approach to prevent metabolic diseases. We would like to thank our teams, partners and shareholders. "

About TOTUM-63, the active substance of VALEDIA®

Prediabetes is an increasingly prevalent public health problem worldwide and recognized by international organizations such as the WHO, the American Diabetes Association and the International Diabetes Federation. 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 to reduce the risk of developing type 2 diabetes. VALEDIA® is the only product that contains the active substance TOTUM-63, a unique and patented combination of 5 plant extracts that act synergistically 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 TOTUM-63 reduces fasting blood glucose levels and blood glucose after 2 hours, two risk factors for type 2 diabetes in people with prediabetes.

All the results from the Phase IIA study, as well as all key company information are available in the updated corporate presentation, available here: www.valbiotis.com/en/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:
http://valbiotis.com/

Name: VALBIOTIS
ISIN code: FR0013254851
Mnemonic code: ALVAL

Disclaimer

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 5 April 2017 (application number I.17-012), as well as in the 2018 annual financial report, filed with AMF on 8 March 2019. 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 ID-RCB Number: 2016-A00484-47
2 Difference of the means of individual variations expressed in %.
3 Difference of the means of individual variations.

Contact information

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

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Aroma Bit to Develop Smartphone Embeddable Ultra-compact Silicon CMOS Based Smell Sensor That Has Dog Nose Equivalent Resolution in 1mm Squared Die Size23.7.2019 01:30:00 CESTPress release

Aroma Bit launched a new subsidiary to develop the next generation smell sensor based on silicon CMOS sensor substrate that are ultra-compact, high resolution and low cost. The technology is realized by applying Aroma Bit developed smell sensor receptor membrane technology to ultra-sensitive silicon CMOS based ion imaging sensor technology developed by professor Kazuaki Sawada at Toyohashi University of Technology and associated companies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190722005004/en/ Picture of 1mm squared die of silicon CMOS based smell sensor, with dog nose equivalent ~1,200 sensor pixels (Photo: Business Wire) Aroma Bit: http://www.aromabit.com Realizing smartphone embeddable smell sensor with dog nose equivalent ultra-high resolution smell sensor on only 1 millimeter square silicon die size Aroma Bit has developed and are currently selling a compact smell sensor that employs QCM or Quartz Crystal Micro

Logitech Delivers a Strong Start to Fiscal Year 2020 with Robust Sales and Profit Growth23.7.2019 01:00:00 CESTPress release

Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the first quarter of Fiscal Year 2020. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190722005781/en/ Logitech delivers a strong start to Fiscal Year 2020 with robust sales and profit growth. (Graphic: Business Wire) Q1 sales were $644 million, up 6 percent in US dollars and 9 percent in constant currency, compared to Q1 of the prior year. Q1 GAAP operating income grew 46 percent to $47 million, compared to $32 million in the same quarter a year ago. Q1 GAAP earnings per share (EPS) grew 17 percent to $0.27, compared to $0.23 in the same quarter a year ago. Q1 non-GAAP operating income grew 11 percent to $67 million, compared to $61 million in the same quarter a year ago. Q1 non-GAAP EPS grew 15 percent to $0.39, compared to $0.34 in the same quarter a year ago. Cash flow from operations was $37 million, compared to $12 million in the sa

Gilead Presents New Data on Biktarvy® for the Treatment of HIV in Women and in Virologically Suppressed Patients With Known Resistance22.7.2019 16:00:00 CESTPress release

Gilead Sciences, Inc. (NASDAQ: GILD) today presented findings from two Phase 3 trials – a trial demonstrating the effectiveness of switching to Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets, B/F/TAF) in women, and a trial evaluating the potential for the single tablet regimen to be an effective treatment option in virologically suppressed patients with known resistance to nucleo(s)tide or non-nucleo(s)tide reverse transcriptase inhibitors (NRTIs or NNRTIs). The use of Biktarvy in patients with known drug resistance is investigational. These data were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) being held in Mexico City. “These data presented at IAS provide new information about the treatment of HIV among women and patients with known drug resistance,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “The studies further demonstrate the potential for Biktarvy to be an

IBC Celebrates Young Talent in the Industry22.7.2019 15:36:00 CESTPress release

The media, entertainment and technology industry is changing. Attitudes are shifting, the next generation is consuming content differently to any before them and diverse and exciting content is being created to meet that demand in innovative formats. Driving this change is a new wave of industry talent, honoured at IBC with the first IBC Young Pioneer Award. Recognising the brightest, newest talent in the industry, this award will go to someone who has made a real impact with their passion, ambition and commitment and is making an outstanding contribution to our industry. “What we were looking for in the shortlist was, most importantly, real talent, a stand-out individual making a real difference in the industry,” said David Levine, VP, Programming - Kids, Europe & Africa/UK & Ireland, The Walt Disney Co. Ltd and Chair of the Judging Panel. “But we were also looking for a lasting legacy, for the Young Pioneer to be a leader today and a media guru of the future.” The call for entries so

Gilead Presents Proof-of-Concept Data for GS-6207, a First-in-Class Capsid Inhibitor, in People Living With HIV22.7.2019 15:00:00 CESTPress release

Gilead Sciences, Inc. (NASDAQ: GILD) today presented the first clinical data in people living with HIV on GS-6207, an investigational, novel, selective, first-in-class inhibitor of HIV capsid function. The Phase 1b data demonstrate the first proof of concept that HIV capsid inhibition can lead to significant declines in viral load in vivo. In addition, Gilead presented preclinical data demonstrating that resistance to GS-6207 in vitro did not lead to resistance to other classes of drugs used in the treatment of HIV. These data were presented at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City. GS-6207 is an investigational long-acting antiretroviral agent that can be delivered subcutaneously. GS-6207 recently received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) as a potential therapy for heavily treatment-experienced people living with multi-drug resistant HIV. GS-6207 acts in a novel way compared with current

Pacific Drilling Appoints James W. Harris as Chief Financial Officer22.7.2019 13:42:00 CESTPress release

Pacific Drilling S.A. (NYSE: PACD), one of the world’s leading deepwater drilling contractors, today announced that Pacific Drilling’s Board has appointed James W. Harris to serve as the Company’s Senior Vice President and Chief Financial Officer. Mr. Harris replaces Mr. Johannes (John) P. Boots, who, as previously announced, mutually agreed with the Company to step down from his position to pursue other opportunities. Mr. Harris has more than 30 years of experience in the energy industry in a variety of financial leadership, strategic and business planning roles. He most recently served as Executive Vice President, Drilling & Subsea for Forum Energy Technologies, Inc., having previously served Forum as Chief Financial Officer for 12 years. Bernie Wolford, the Company’s Chief Executive Officer, stated, “We sincerely appreciate the many contributions that John has made during his nearly 10-year tenure with Pacific Drilling and we wish him all the best in his future endeavors.” “We are e