Periodic Reporting for period 1 - WOMED (WOMED: an innovative intrauterine biodegradable polymer-based drug-delivery platform)
Reporting period: 2024-05-01 to 2025-04-30
Every woman experiences some form of uterine disorder during her lifetime, including excessive bleeding, pelvic pain, and fertility issues, posing an enormous burden for women worldwide. Current treatments have limitations & painful side effects. Fibroids and endometriosis are two of the most relevant unmet needs in women health. For fibroids, an extremely common condition affecting 51% of women between 35-49, the withdrawal of Esmya, a highly appreciated treatment, has left a gap in effective options. Meanwhile, women with endometriosis (10% women in reproductive years) suffer incapacitating pain that is poorly managed with systemic analgesics. There is an urgent need for better treatments. Womed was founded in Montpellier by Gonzague Issenmann, a serial MedTech entrepreneur, to revolutionize the women health industry by changing the paradigm of uterine disorders treatment. Womed develops safe and effective local intrauterine therapies. Our unique and patented copolymer structure allows for easy insertion, biodegradability and sustained and controlled local drug delivery. Our first product, Womed Leaf, is a drug-free intrauterine device that prevents adhesions and restores fertility. Based on Leaf’s polymer, we are developing a uterine drug delivery platform with Fibroid, a medical treatment for fibroids, and ReLeaf, a nonhormonal treatment to alleviate endometriosis-related pain.
- Pharmacokinetic (PK) Study Completion: A PK study in sheep was successfully organized and executed to evaluate the local delivery of mifepristone, which confirmed the intended local action and minimal systemic exposure of the drug formulation.
- CDMO Selection and Process Transfer: a Contract Development and Manufacturing Organization (CDMO) in the EU was selected. Analytical methods and manufacturing processes were successfully transferred to the CDMO. Initial extrusion runs successfully reproduced the WOMED formulation, achieving appropriate control over drug content and homogeneity.
- Regulatory Pathway Confirmation: Positive Scientific Advice was received from the a national pharmaceutical Agency in Europe, which confirmed the suitability of the proposed development plan for the Fibroid drug product.
- CDMO Selection and Process Transfer: a Contract Development and Manufacturing Organization (CDMO) in the EU was selected. Analytical methods and manufacturing processes were successfully transferred to the CDMO. Initial extrusion runs successfully reproduced the WOMED formulation, achieving appropriate control over drug content and homogeneity.
- Regulatory Pathway Confirmation: Positive Scientific Advice was received from the a national pharmaceutical Agency in Europe, which confirmed the suitability of the proposed development plan for the Fibroid drug product.
The project aims to establish a new standard of care for uterine fibroids by enabling the safe, localized delivery of Selective Progesterone Receptor Modulators (SPRMs) directly within the uterus. This approach represents a significant advancement beyond the current state of the art, which often involves systemic drug administration with associated side effects or invasive surgical procedures.
Initial detailed discussions with Key Opinion Leader (KOL) Professors in Gynecology, have validated the potential impact of this approach. These experts expressed significant enthusiasm for the prospect of a treatment that allows for targeted SPRM delivery, potentially minimizing systemic risks while effectively treating fibroids. This positive reception from leading specialists underscores the project's potential to address a critical unmet need in women's health, offering a potentially safer and more targeted therapeutic option compared to existing treatments. Further development and clinical validation are key next steps towards realizing this potential impact.
Initial detailed discussions with Key Opinion Leader (KOL) Professors in Gynecology, have validated the potential impact of this approach. These experts expressed significant enthusiasm for the prospect of a treatment that allows for targeted SPRM delivery, potentially minimizing systemic risks while effectively treating fibroids. This positive reception from leading specialists underscores the project's potential to address a critical unmet need in women's health, offering a potentially safer and more targeted therapeutic option compared to existing treatments. Further development and clinical validation are key next steps towards realizing this potential impact.