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Daré Bioscience and Theramex Partner to Develop Novel Biodegradable Contraceptive Implant

• Daré Bioscience and Theramex have entered into a co-development agreement for Casea S, a first-in-category biodegradable contraceptive implant designed to last 18-24 months.

• The innovative implant eliminates the need for surgical removal, addressing a key barrier in current contraceptive implants while offering women a convenient, long-acting contraceptive option.

• A foundation-funded Phase 1 trial is currently underway to evaluate the pharmacokinetics, removability, safety, and tolerability of Casea S.

Daré Bioscience (NASDAQ: DARE) and Theramex have joined forces to develop Casea S, a potentially groundbreaking biodegradable contraceptive implant that could transform long-acting contraceptive options for women. The collaboration, announced today, marks a significant step forward in addressing the limitations of current contraceptive implants.
The innovative Casea S implant is designed to provide contraception for 18-24 months before naturally dissolving in the body, eliminating the need for surgical removal - a common deterrent for women considering implanted contraceptives. This unique feature could significantly improve the adoption of long-acting contraceptive methods.
"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," explained Rob Stewart, CEO of Theramex. "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."

Clinical Development Status

The development program is currently in Phase 1, with FHI 360 conducting a fully-funded trial to investigate key aspects of the implant's performance. The study (ClinicalTrials.gov ID: NCT05174884) focuses on:
  • Pharmacokinetics
  • Removability characteristics
  • Safety profile
  • Overall tolerability

Strategic Partnership Structure

Under the agreement terms, Daré has received a royalty-free, exclusive license to the US patents for Casea S. The current Phase 1 study is supported by a foundation grant, requiring no immediate development costs from either company. Future development costs for Phase II and III studies in the US will be shared between Daré and Theramex, with specific terms to be determined based on market potential.
"We are thrilled that Theramex selected Daré as its development partner for this potentially disruptive long-acting, minimally-invasive contraceptive candidate," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. "The fully funded ongoing Phase 1 study is external validation of this important technology."

Market Impact and Innovation

The development of Casea S represents a significant advancement in contraceptive technology, potentially offering several advantages over existing options:
  • Biodegradable design eliminating removal procedures
  • Extended duration of action (18-24 months)
  • Minimally invasive insertion
  • Improved convenience for users
  • Reduced healthcare provider involvement
This collaboration combines Daré Bioscience's expertise in women's health innovation with Theramex's global presence in specialty pharmaceuticals, positioning Casea S for potential success in addressing unmet needs in contraceptive care.
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Highlighted Clinical Trials

NCT05174884Active, Not RecruitingPhase 1
FHI 360
Posted 12/13/2023

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