Valbiotis Announces Approval to Launch the Two Phase II/III INSIGHT and INSIGHT 2 Clinical Studies, the Last Step in the Development of TOTUM•854 For the Reduction of Blood Pressure
Regulatory News:
Valbiotis (Paris:ALVAL) (FR0013254851 – ALVAL, PEA / SME eligible), a Research and Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has received approval to launch the two international multicenter Phase II/III INSIGHT and INSIGHT 2 clinical studies on TOTUM•854, for the reduction of blood pressure. These two trials will include 800 volunteers with mild to moderate elevated blood pressure, a risk factor for cardiovascular diseases, with 400 volunteers in each study. The authorizations received enable the launch of clinical recruitment, scheduled to be completed in the first half of 2023.
Murielle CAZAUBIEL, member of the Board of Directors, Director of Medical, Regulatory and Industrial Affairs at Valbiotis, commented: "The approvals received for the INSIGHT and INSIGHT 2 clinical studies are an important milestone for the development of TOTUM•854, which is now entering its final stage. They allow us to begin an ambitious recruitment phase - 800 volunteers in total - for these international Phase II/III studies. In addition, from a medical point of view, the validation of the protocols by the health authorities confirms the innovative positioning of TOTUM•854 in the field of hypertension. The INSIGHT and INSIGHT 2 trials, through their methodology, should now provide the clinical evidence that will support the promise of this active substance for the management of the early stages of arterial hypertension".
TOTUM•854 is the second plant-based active substance in the Valbiotis product portfolio to enter Phase II/III clinical studies and will address the lack of non-drug treatment for hypertension, complementing therapeutic solutions and supported by strong scientific evidence.
The results of the two INSIGHT and INSIGHT 2 clinical studies are essential for a health claim application for the reduction of blood pressure, a risk factor for cardiovascular diseases, in Europe and the United States. They will comply with the protocols validated by the competent authorities:
- The INSIGHT Phase II/III international, multicenter, randomized, placebo-controlled clinical study will be conducted on a population of 400 volunteers with mild to moderate elevated blood pressure (systolic blood pressure between 130 mmHg and 159 mmHg and diastolic blood pressure < 100 mmHg). It will include two groups: a TOTUM•854 group with a dose of 3.7 g/day and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group. In addition, 24-hour ambulatory blood pressure measurement will be performed and will be one of the secondary endpoints of the study.
- The INSIGHT 2 clinical study, also international, multicenter, randomized and placebo-controlled, will be carried out on 400 other subjects with the same inclusion criteria. There will be two groups: a TOTUM•854 group receiving a reduced dose (2.6 g/day) and a placebo group. The primary endpoint will be a reduction in systolic blood pressure, after 3 months of supplementation, between the TOTUM•854 group and the placebo group.
In addition to these clinical efficacy studies, the development plan for TOTUM•854 includes a bioavailability and mode of action study in 10 volunteers to characterize TOTUM•854 metabolites and identify their effects on human cell lines. The results are expected by the end of 2022.
About Valbiotis
Valbiotis is a Research & Development company committed to scientific innovation for preventing and combating metabolic diseases in response to unmet medical needs.
Valbiotis has adopted an innovative approach, aiming to revolutionize healthcare by developing a new class of health nutrition products designed to reduce the risk of major metabolic diseases, relying on a multi-target strategy enabled by the use of plant-based terrestrial and marine resources.
Its products are intended to be licensed to players in the health sector.
Created at the beginning of 2014 in La Rochelle, the Company has forged numerous partnerships with leading academic centers. The Company has established three sites in France – Périgny, La Rochelle (17) and Riom (63) – and a subsidiary in Quebec City (Canada).
Valbiotis is a member of the "BPI Excellence" network and has been recognized as an "Innovative Company" by the BPI label. Valbiotis has also been awarded "Young Innovative Company" status and has received major financial support from the European Union for its research programs via the European Regional Development Fund (ERDF). Valbiotis is a PEA-SME eligible company.
For more information about Valbiotis, please visit: www.valbiotis.com
Name: Valbiotis
ISIN code: FR0013254851
Mnemonic code: ALVAL
EnterNext© PEA-PME 150
This press release contains forward-looking statements about Valbiotis’ objectives. Valbiotis considers that these projections are based on rational hypotheses and the information available to Valbiotis at the present time. However, in no way does this constitute a guarantee of future performance, and these projections may be affected by changes in economic conditions and financial markets, as well as certain risks and uncertainties, including those described in the Valbiotis Universal Registration Document approved by the French Financial Markets Regulator (AMF) on July 27, 2021 (application number R 21-039). This document is available on the Company’s website (www.valbiotis.com). This press release and the information it contains do not constitute an offer to sell or subscribe, or a solicitation to purchase or subscribe to Valbiotis’ shares or financial securities in any country.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220216005832/en/
Contact information
Corporate communication / Valbiotis
Carole ROCHER / Marc DELAUNAY
+33 5 46 28 62 58
media@valbiotis.com
Financial communication / Actifin
Stéphane RUIZ
+33 1 56 88 11 14
sruiz@actifin.fr
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Access Advance Announces HEVC Advance and VVC Advance Pricing through 203022.7.2025 03:00:00 EEST | Press release
Access Advance LLC (“Advance”) today announced the results of several significant decisions by the Licensors in both the HEVC Advance and VVC Advance Patent Pools. Both patent pools opted to maintain their current royalty rates and caps for Licensees who sign before December 31, 2025, and to extend an incentive that aligns the royalty caps for Advance’s Multi-Codec Bridging Agreement (“MCBA”) and the VVC Advance Patent Pool for Licensees who sign the MCBA during the same period. The result is that Licensees who join the HEVC Advance program, gaining access to more than 27,000 patents, on or before December 31, 2025, can lock in current rates and caps through 2030. This protection applies both to ongoing royalty obligations and calculation of royalties due for past sales. Additionally, both current and new HEVC Advance Licensees who join the VVC Advance Patent Pool and execute the MCBA by December 31, 2025, will enjoy MCBA royalty caps that match the royalty caps for the VVC Advance pro
MayMaan Launches Engine Integration Program to Accelerate Clean Combustion Deployment and Market Adoption21.7.2025 20:34:00 EEST | Press release
MayMaan, a scale-up innovator, transforming combustion technology, is announcing a robust and scalable partnership model to support the transition to more efficient power systems across global industries whilst cutting harmful emissions such as NOx and SOx to levels that are practically immeasurable. At the heart of MayMaan’s offering is its proprietary AquaStroke® technology, which runs on a revolutionary 70% water and 30% ethanol fuel blend. This patented system delivers high torque and reliability while dramatically reducing emissions—offering a compelling alternative to diesel engines and electrification overhauls. “Our technology is more than a breakthrough—it’s a platform designed to help others succeed,” said Doron Shmueli, Founder and CEO at MayMaan. “From manufacturers to distributors, we provide a full solution—ready to integrate, easy to scale, and built for the energy demands of tomorrow.” Tailored Solutions for Industry Leaders MayMaan’s clean combustion platform is now av
Armis Named a Leader in Unified Vulnerability Management Solutions, Q3 2025 Evaluation21.7.2025 18:25:00 EEST | Press release
Armis, the cyber exposure management & security company, today announced that it has been named a Leader in The Forrester Wave™: Unified Vulnerability Management Solutions, Q3 2025. In this Forrester Wave™, Armis is ranked a Leader and achieved the highest score in the Current Offering category. According to the report, “Armis’ strategy is grounded in proactive security principles… Armis is an excellent fit for either beginner organizations starting their proactive security journey or mature organizations that need leading vulnerability response capabilities.” “I believe Armis stood out as a Leader because Armis CentrixTM is different – it’s a platform built to help organizations reduce cyber risk, not just report on it,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “We are redefining what security should look like in a connected world, helping organizations move from passive defense to proactive control so that they can take action before there’s any impact on their environment.
DevvStream Completes $10M Initial Funding to Launch $300M Asset-Backed Digital Infrastructure and Sustainability Strategy21.7.2025 18:00:00 EEST | Press release
DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management firm specializing in the development, investment, and sale of environmental assets, today announced that it has entered into a securities purchase agreement for the issuance of up to (US)$300 million in senior secured convertible notes (“Senior Notes”), advancing its strategic initiative to build a blockchain-based treasury and launch a tokenization platform for sustainability-linked infrastructure. The securities purchase agreement provides for the issuance of up to (US)$300 million in Senior Notes with Helena Partners, which issuances will be funded in multiple tranches. An initial funding of (US)$10 million was completed on July 18, 2025. Key Highlights: Under the agreement, DevvStream will allocate 75% of the net proceeds (70% of the initial tranche) toward the purchase of liquid digital assets that offer 24/7 liquidity, serve as non-correlated stores of value, and may be used as collateral
McCauley Propeller Systems High-Performance C780 Propeller Now Factory Standard for New Beechcraft King Air 360 Customers21.7.2025 16:00:00 EEST | Press release
McCauley Propeller Systems, a division of Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced its C780 propeller, which had previously been optional for factory installation, is now standard for all new commercial customers of the Beechcraft King Air 360. The first King Air 360 equipped with the propeller recently rolled out of production at Textron Aviation’s factory in Wichita, Kansas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250720080635/en/ McCauley Propeller Systems high-performance C780 propeller now factory standard for new Beechcraft King Air 360 customers (Photo Credit: McCauley Propeller Systems) "As a leading full-line propeller manufacturer, being featured on the factory line of the legendary Beechcraft King Air 360 underscores our commitment to excellence," said Jason Hull, vice president and general manager, McCauley Propeller Systems. “The C780 offers a sophisticated and durable de
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom