Israel’s Gynica starts clinical trial for endometriosis cure

Israeli biotech startup Gynica announces it has launched a clinical trial for a treatment for endometriosis, raising hopes for a cure for the disease, which afflicts one in 10 women and girls of reproductive age around the world.

Chief executive Yotam Hod says Gynica had been doing pre-clinical research and development for the past four years towards “this enormous unmet need.”

Endometriosis, which has no known cure, affects about 190 million females of reproductive age globally, according to the World Health Organization.

The disease causes tissue similar to the uterus lining to grow outside it, potentially causing severe pain in the pelvis or making it harder to get pregnant.

“This trial represents a significant step forward in our mission to revolutionize care and provide a better quality of life for the millions of women worldwide suffering from endometriosis,” Hod says.

The first-of-its-kind clinical study would evaluate the safety, tolerability, and interaction of its intra-vaginal drug delivery platform and two proprietary drug candidates, S-301 and S-302, the company says. It will be conducted at Careggi University Hospital in Florence, Italy.

Pending positive Phase 1 results, the company says it would start Phase 2 efficacy trials promptly.

Gynica aims to register its novel solutions with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).