Hyloris Pharmaceuticals SA announced that it has entered into a partnership with AFT Pharmaceuticals (AFT) to develop a novel mucoadhesive film for the treatment of Vulvar Lichen Sclerosus. HY-091 targets to have an extended duration release of a known molecular entity and to offer a convenient application method, ensuring simplicity and improving compliance. Under the terms of the agreement, Hyloris and AFT will co-develop HY-091 for the purpose of registration and worldwide commercialization.

Hyloris is responsible for ensuring the product formulation, manufacturing activities and the coordination of the commercialisation in Europe. AFT is responsible for managing the clinical trials, overseeing all aspects to ensure effective planning, execution and monitoring throughout the trial lifecycle, and the coordination of the commercialization outside of Europe. Parties are jointly responsible for commercialization in the United States.

This partnership and the recently announced collaboration on HY-090 for Burning Mouth Syndrome are a testament to shared commitment to making a meaningful impact on the healthcare system. By combining resources and expertise, the company is poised to pioneer innovative solutions for patients suffering from VLS. Vulvar Lichen SclerosUS (VLS) is a chronic, distressing, inflammatory disease with an enormous impact on quality of life.

HY-091 is designed as a user-friendly mucoadhesive film product with a convenient application method that ensures simplicity and compliance, offering targeted relief for patients experiencing the discomfort, switching, and pain associated with Vulvar Lichen SclerOSus by reducing inflammation and scarring in the affected area of skin and helping in restoring the skin structure. There is no curative treatment for VLS, which usually occurs in postmenopausal women, although children and premenopausal women may be affected. Advanced condition severely affects the quality of life and is associated with increases risk of vulvar squamous cell carcinoma.

It is a massively under diagnosed condition, which affects 0.1% to 3% of the general population.