(News Bulletin 247) – The company announced on Tuesday that a phase 2/3 clinical study evaluating this food supplement intended to prevent the onset of type 2 diabetes had reached its main endpoint. This triggers a milestone payment of 4 million Swiss francs from its partner Nestlé Health Science.
TP ICAP Midcap sums up the challenge well: “it was the event of the year for Valbiotis”. The La Rochelle-based company, which develops products to prevent and fight against metabolic and cardiovascular diseases, has delivered convincing clinical results for its food supplement TOTUM-63.
This product combines five plant extracts that target type 2 pathophysiological mechanisms. Concretely, this food supplement aims to prevent type 2 diabetes in patients with prediabetes, that is to say a state at risk likely to develop type 2 diabetes, and patients with early stage diabetes.
Valbiotis announced that the REVERSE-IT Phase 2/3 clinical study (Phase 3 being the last step before potential commercialization) evaluating TOTUM-63 has achieved its objectives on its primary endpoint, namely to significantly reduce the fasting blood sugar, with two or three daily intakes of the food supplement. This study was conducted on 636 patients with prediabetes or with type 2 diabetes at an early stage.
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Nestlé Health Science payment
“We have provided unequivocal clinical proof that TOTUM-63 is a promising solution for millions of people around the world, helping to prevent the progression to type 2 diabetes”, declared the chairman of the executive committee of Valbiotis, Sébastien Peltier, quoted in a press release.
The company will then publish the complete results of the study with the secondary endpoints and the exploratory analyses.
The success of this clinical study has already triggered a milestone payment of 4 million Swiss francs (4.12 million euros) from its partner Nestlé Health Science (NHS), in accordance with an agreement signed in 2020. with the division of the Swiss food group, which deals with the development and marketing of TOTUM-63.
According to TP ICAP Midcap, the company is also maintaining its objective of the first deliveries of the food supplement to the NHS in the first half of 2024, “reasonably suggesting a marketing in the second half”.
A profile with very little risk
On the Paris Stock Exchange, Valbiotis shares took off following these announcements, taking 18.3% to 4.39 euros around 11:40 a.m.
“Yesterday’s announcement of the success of REVERSE-IT brings a three-year clinical adventure to a close with the achievement of the objective for the main endpoint, the reduction of fasting blood sugar, with strong statistical significance. (.. ) This clinical success significantly reinforces the credibility of the group and validates the strategy”, appreciates Invest Securities, which raised its price target to 12.3 euros against 10.3 euros and reiterated its recommendation to buy.
“The turning point of the year announced is therefore intended to be a clear success on the side of Valbiotis which, within 12 months, should have two of the four products in its pipeline on the market”, appreciates for its part TP ICAP Midcap. The design office considers that the profile of the group was “already derisked” but becomes “even more so” following these results. He also confirmed his advice to buy
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