Gynica Initiates Innovative IntraVag© Clinical Trial for Endometriosis Treatment

Gynica, a biotech startup focused on women's health, has initiated a groundbreaking Phase 1 clinical trial in conjunction with Endometriosis Awareness Month, aiming to improve the lives of over 200 million women affected by the condition globally. The study, to be conducted at Careggi University Hospital in Florence, will assess the IntraVag© drug delivery system and two unique, non-hormonal drug candidates, S-301 and S-302, for their safety, tolerability, and pharmacokinetic profile.
Founded in 2019, Gynica is dedicated to addressing endometriosis, a prevalent and debilitating disease that leads to the abnormal growth of tissue similar to the lining of the uterus in places outside the uterus, significantly impacting the quality of life for approximately one in ten women of reproductive age. Despite the condition's significant economic burden, estimated at $180 billion annually by the World Economic Forum and McKinsey's Health Institute, endometriosis remains a largely untreated area with a pressing need for innovative and effective treatments.
The clinical trial will explore Gynica's proprietary cannabinoid-based formulations, which are administered intravaginally, leveraging the therapeutic potential of cannabinoids in women's health. The study is to be headed by Prof. Felice Petraglia, a leading expert in endometriosis and a former president of the Society for Endometriosis and Uterine Disorders (SEUD). The focus will be on how these cannabinoids interact with the endocannabinoid system (ECS), which is prevalent in reproductive organs like the uterus and ovaries, potentially offering relief from endometriosis-related pain and reducing inflammation associated with the disease.
Gynica's IntraVag technology facilitates the targeted and controlled release of active pharmaceutical ingredients (APIs) to the intended organs. The company is working towards obtaining regulatory approval from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). With successful results from the Phase 1 trial, Gynica intends to swiftly proceed to Phase 2 efficacy trials.
Yotam Hod, CEO of Gynica, expressed excitement about the trial, highlighting its significance in the company's mission to transform care for endometriosis patients and enhance their quality of life. Prof. Petraglia emphasized the importance of non-hormonal treatments for endometriosis-associated pain, particularly for patients in need of long-term management and for gynecologists seeking new therapeutic options with diverse mechanisms of action.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!