Daré Bioscience and Theramex have announced a co-development and licensing agreement for Casea S, a potential first-in-category biodegradable contraceptive implant. The collaboration comes as an ongoing Phase 1 study, funded by a foundation grant, evaluates the device’s potential.
The contraceptive implant is designed to release contraception over 18-24 months before dissolving, eliminating the need for surgical removal. This feature could address a significant barrier associated with current implanted contraceptives, which require professional removal.
“We are thrilled that Theramex selected Daré as its development partner for this potentially disruptive long-acting, minimally-invasive contraceptive candidate. The fully funded ongoing Phase 1 study is external validation of this important technology, and enables Daré and Theramex to make future development decisions based on results of the study,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
Under the agreement, Daré has received a royalty-free, exclusive license to the US patents recently acquired by Theramex for Casea S. The current Phase 1 trial, conducted by FHI 360 with foundation grant support, is investigating the pharmacokinetics, removability, safety, and tolerability of the device.
“A biodegradable implant for contraception resonates with what we hear from women as does the idea that she can make that choice every 18-24 months as to whether it is right for her. With its innovative design, Casea S would only require a single surgery visit, offering a more convenient, reversible alternative to existing long-acting contraceptive methods that would enable women to take control of their reproductive health with confidence,” said Rob Stewart, CEO of Theramex.
If the Phase 1 results prove positive, Daré will lead the Phase II study in the US. The funding for both Phase II and future Phase III studies in the US will be shared between Daré and Theramex, with specific terms to be determined based on the market opportunity in their respective territories.
The collaboration leverages both companies’ expertise in women’s health. Daré Bioscience has established itself in developing innovative women’s health products, including XACIATO for bacterial vaginosis and Ovaprene, a hormone-free monthly contraceptive. Theramex brings extensive experience in women’s health, with a portfolio covering contraception, fertility, menopause, and osteoporosis.
