Contraceptive Alternatives

In the reproductive health and contraceptive market segment, there are an estimated 64 million women in the US alone¹. While the FDA has approved many different types of contraception², gaps remain in the method mix. Women have different needs and preferences and may use a variety of birth control methods over the course of their reproductive lives. And, it goes without saying, one size does not fit all.

While tremendous innovation has occurred in hormonal contraception since the introduction of the daily birth control pill in 1960, innovation to improve convenience and efficacy in non-hormonal methods has lagged. Surveys have shown that when it comes to contraception, women value convenience and efficacy. Many women would prefer a contraceptive method they don’t need to remember to take every day and that doesn’t require action at the time of intercourse. Nearly 85% would prefer a monthly option with a lower hormone dose than the oral birth control pill.³  at Daré are working to offer women a contraceptive option with these features.

Our Investigational Candidate, Ovaprene®

Ovaprene® is an investigational hormone-free monthly intravaginal drug/device designed to be an easy-to use monthly option and prevent pregnancy by releasing a locally acting, non-hormonal agent which impedes sperm motility, and physically blocking sperm from entering the cervical canal with its unique knitted polymer barrier. The novel combination of these complementary approaches has the potential to produce efficacy consistent with existing short-acting hormone birth control options (pills, patches, vaginal ring), without the use of hormones.

Postcoital test (PCT) Study, Previously Completed

Postcoital test (PCT) clinical trials have been used as a surrogate marker for contraceptive effectiveness.⁴

PCT Study Results

In a postcoital test study of Ovaprene®, it successfully immobilized sperm and prevented their progression into the cervical canal.

• Ovaprene prevented the requisite number of sperm from reaching the cervix across all women and all cycles evaluated.
• Specifically, in 100% of women and cycles, an average of less than five (< 5) progressively motile sperm (PMS) per high-powered field (HPF) were present in the midcycle cervical mucus collected two to three hours after intercourse with Ovaprene in place.
• Women enrolled in the study who completed at least one Ovaprene PCT (N=26) had a mean of 27.21 PMS/HPF in their baseline cycle (without any contraceptive device), a mean of 0.22 PMS/HPF in their diaphragm cycle (in the presence of an FDA-cleared diaphragm with spermicide), and a mean of 0.48 PMS/HPF in their Ovaprene PCT cycles (in the presence of the Ovaprene device), with a median of zero PMS.

	Mean Progressively Motile Sperm	Median Progressively Motile Sperm	Standard Deviation	Interquartile Range
Baseline PCT’s	27.21	23.20	17.88	24.80
Ovaprene PCT’s	0.48	0.00	1.18	0.10

In PCT studies of similar size, products (diaphragms) that demonstrated no motile sperm in the cervical mucus during PCT assessments later demonstrated “typical use” contraceptive effectiveness of 86-91% in pivotal contraceptive studies evaluating pregnancy rates over six-month periods.⁵

Based on the positive results of our PCT study, we submitted an Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). During the fourth quarter of 2022, we announced that the FDA approved our IDE application allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®.

 Cooperative Research and Development Agreement with NIH

In July 2021, Daré  announced a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD), part of the National Institutes of Health (NIH), for the pivotal Phase 3 study of Ovaprene®. The agreement allows us to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.

Pivotal Phase 3 Study

Study recruitment in the Ovaprene pivotal phase 3 study commenced in December of 2023.

Pivotal Study Overview

• A multi-center, single arm, non-comparative study meaning all women will use Ovaprene – there is no placebo
• Target: evaluate Ovaprene’s effectiveness as a contraceptive device along with its safety and usability in approximately 250 subjects over a 12-month duration (13 menstrual cycles)
• Primary objective: typical use pregnancy rate over 13 menstrual cycles (estimated Pearl Index)
• Secondary objectives:
  • 13-cycle typical use cumulative pregnancy rate
  • Safety, acceptability, product fit/ease of use, vaginal health
• If successful, we expect the pivotal study to support marketing approvals of Ovaprene® in the U.S. and other countries. If Ovaprene® is approved by the FDA, it could be the first monthly non-hormonal contraceptive option for women and a first-in-category therapy for women seeking a hormone-free, self-administered birth control method.

Ovaprene Commercial License Agreement with Bayer

• January 2020 – Bayer, which markets the $1 billion Mirena contraceptive franchise, and Daré announced the execution of a license agreement under which Bayer may commercialize Ovaprene investigational contraceptive in the US once approved by FDA.
• Bayer received the right to obtain exclusive U.S. rights to commercialize the product, following completion of the pivotal clinical trial if Bayer, in its sole discretion, pays Daré $20 million.
• Daré may receive up to $310 million in commercial milestone payments, plus double-digit, tiered royalties on net sales of Ovaprene.
• Bayer is supporting the development and regulatory process by providing up to two full-time equivalents (internal experts) in an advisory capacity, which gives Daré access to their global manufacturing, regulatory, medical and commercial expertise.

 Read more about our License Agreement with Bayer here.

 Ovaprene is part of a diverse portfolio of contraceptive products in development that include DARE-204/214, 6 & 12-month injectable formulations of etonogestrel being developed as a longer-acting, reversible method of contraception with a more predictable return to fertility; DARE-LARC1, a levonorgestrel-releasing implant drug delivery system being developed to allow one to remotely pause and resume dosing; and DARE-RH1, a novel male or female contraceptive solution that targets sperm hypermotility required for implantation.

 *This page includes forward-looking statements subject to qualifications described in the Terms of Service, including Section 13.4, Forward-Looking Statements; Disclaimer.

 

Ovaprene Footnotes

1. Sources: US Census Bureau and population estimates based on bridged race categories released by the National Center for Health Statistics.
2. https://www.fda.gov/media/150299/download
3. https://pubmed.ncbi.nlm.nih.gov/20818837/
4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7401356/
5. Mauck C., Vincent K. Biology of Reproduction, Volume 103, Issue 2, August 2020, Pages 437–444