Gynica, a clinical-stage biotech startup focused on women’s health, has announced the initiation of a first-in-human Phase 1 clinical trial for a novel Endometriosis treatment. Led by renowned expert Prof. Felice Petraglia, the study aims to evaluate Gynica’s non-hormonal, intra-vaginal drug candidates using the IntraVag intra-vaginal drug delivery platform.

Endometriosis, affecting over 200 million women worldwide, is characterized by the abnormal growth of uterine-like tissue outside the uterus. Despite its widespread prevalence and substantial economic burden, effective treatment options for Endometriosis remain limited.

The Phase 1 clinical trial, conducted at Careggi University Hospital in Florence, Italy, will focus on assessing the safety, tolerability, and pharmacokinetics of Gynica’s IntraVag platform and its proprietary drug candidates, S-301 and S-302. Leveraging pharmaceutical-standard cannabinoids, the formulations explore their potential as therapeutic agents in women’s health.

Prof. Felice Petraglia, a distinguished expert in Endometriosis, will lead the trial. As the past President and founding member of the Society for Endometriosis and Uterine Disorders (SEUD), Prof. Petraglia brings extensive expertise to the study. The trial will assess the efficacy of cannabinoids in engaging with the endocannabinoid system (ECS), crucial in reproductive organs like the uterus and ovaries.

Gynica’s proprietary IntraVag technology enables precise delivery of active pharmaceutical ingredients (APIs) to target organs, offering a promising avenue for treating Endometriosis-associated pain. Pending positive results from the Phase 1 trial, Gynica plans to swiftly advance into Phase 2 efficacy trials, aiming for registration with regulatory authorities such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

“After four years of rigorous pre-clinical research and development efforts, we are thrilled to announce this upcoming milestone during Endometriosis Awareness Month. This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis. In this enormous unmet need, patients urgently seek efficient solutions,” stated Yotam Hod, CEO of Gynica.

“Endometriosis is now recognized as a chronic disease, and to have a non-hormonal treatment for Endometriosis-associated pain has an absolute priority for many patients who require long-term management and for the gynecologist in order to have new therapeutic options with multiple mechanisms of action”, says Prof. Petraglia.

As Gynica advances its clinical trials, it signals hope for Endometriosis patients worldwide, offering the prospect of innovative and effective treatments to alleviate their symptoms and improve their quality of life.

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