Phase II Clinical Trial
Pioneering New Frontiers in Endometriosis Treatment
At FORAVISET, we are preparing to launch a pivotal Phase II clinical trial to evaluate the efficacy and safety of our innovative non-hormonal therapy, Raviset®, for the treatment of endometriosis. This groundbreaking trial will involve 128 women and will be conducted at two of Israel’s leading medical centers: Hadassah Medical Center and Carmel Medical Center. While the trial is expected to span up to two years, we are hopeful that interim results will arrive much earlier, affirming our belief that Raviset® is on track to transform therapy for this debilitating condition.
A Strong Foundation for Innovation
Our optimism for this trial is grounded in over two decades of rigorous preclinical and clinical research, which has established a robust foundation for Raviset®’s development. Key milestones include:
- A single-blind, placebo-controlled Phase I Clinical Study conducted on 12 healthy volunteers in Germany, fully compliant with Good Clinical Practice (GCP) guidelines, demonstrated a high safety profile and broad therapeutic window.
- Toxicological Studies conducted in Germany under Good Laboratory Practice (GLP) requirements.
- ADME Studies performed in Canada to evaluate absorption, distribution, metabolism, and excretion, in full compliance with GLP standards.
- Analytical Method Validation finalized under GLP requirements, ensuring consistency and reliability in drug analysis.
- Drug Substance Production completed in the United States, fully compliant with Good Manufacturing Practice (GMP) standards.
Proof of Concept Clinical Trial on 85 Women
The drug has not only successfully completed a Phase I safety clinical trial but has also been tested for efficacy in real-world conditions. A proof-of-concept clinical trial involving 85 women suffering from primary dysmenorrhea, secondary dysmenorrhea, and abnormal uterine bleeding yielded extraordinary results:
- Among women with high-intensity primary dysmenorrhea, over 83% reported significant pain relief.
- For those with secondary dysmenorrhea, including women with endometriosis, more than 87% experienced a significant recovery from pain.
- Similar results were observed in women with abnormal uterine bleeding.
This early trial provided invaluable insights and directly informed the design of the upcoming Phase II clinical trial. These outcomes also strongly suggest the anticipated success of this pivotal study.