Biodegradable implant systems release a contraceptive steroid for a set period of time before dissolving and provide users with a long-acting method choice that will not require a visit to a health care provider for removal. Previous work on this method, under the Contraceptive Technology Innovation (CTI) Initiative, has allowed researchers at FHI 360 and their development partners, pH Sciences and GeSea Biosciences, to develop a biodegradable implant called the Casea S. New supplemental funding from the Bill & Melinda Gates Foundation will allow development activities to continue, including preclinical work on the Casea S product, in addition to the first human study.
Research activities under this project include:
- Conducting a Phase 1 trial to investigate pharmacokinetics, removability, safety and tolerability of the Casea S implant
- Conducting user and provider acceptability research
- Optimizing formulation and manufacturing processes for the Casea S to support later stages of clinical development
- Performing animal studies to evaluate pharmacokinetics of optimized formulations
Biodegradable implants, like the Casea S, offer a unique set of attributes to potential users, including an intermediate duration of use (18-24 months) and a lack of need for removal, which would increase convenience and potentially lead to cost-savings for both women and health systems.