Valbiotis SA has announced positive results from its Phase II/III HEART II clinical trial, demonstrating the efficacy of Lipridrive in reducing LDL cholesterol levels in individuals with mild to moderate hypercholesterolemia. The study, conducted across multiple centers internationally, involved 180 participants and compared Lipridrive at a dose of 5g per day against a placebo over a three-month period.
The HEART II trial met its primary endpoint, showing a statistically significant reduction in LDL cholesterol in the Lipridrive group compared to the placebo group (p < 0.01). This outcome mirrors the positive results observed in the earlier Phase II HEART study, further validating Lipridrive's potential as a therapeutic intervention for managing hypercholesterolemia.
Safety and Tolerability
In addition to its efficacy, Lipridrive demonstrated a strong safety profile and was well-tolerated by participants. The study reported a compliance rate exceeding 98%, indicating that patients found the regimen manageable and acceptable.
Expert Commentary
Professor Emeritus of Biochemistry, Jean-Marie Bard, highlighted the significance of the findings: "Hypercholesterolemia is a major cardiovascular risk factor that affects millions of people. The HEART II and HEART clinical trials, involving over 300 people, demonstrate the efficacy of a red-yeast-rice-free, drug-free solution for the management of mild-to-moderate hypercholesterolemia with an unprecedented level of scientific and clinical evidence."
Future Directions
Valbiotis plans to present the complete findings from the HEART II study at upcoming international scientific conferences and publish them in peer-reviewed journals. This will allow for broader dissemination of the results and further scrutiny by the scientific community.
Valbiotis' Perspective
Sébastien Peltier, PhD, CEO and Co-Founder of Valbiotis, expressed his enthusiasm about the trial's success: "We are proud to announce these positive clinical results, which mark the culmination of an exemplary phase of clinical development... Our commitment to making a tangible contribution to public health is the driving force behind this determination."
