Includes positive clinical findings from a postcoital test (PCT) human clinical study of Ovaprene®, an investigational hormone-free, monthly contraceptive
SAN DIEGO, June 24, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced the publication of a literature review article by Biology of Reproduction that identifies and reviews 10 postcoital test (PCT) studies of vaginal contraceptives involving 9 test products, including Daré's investigational hormone-free, monthly contraceptive Ovaprene, currently under a license agreement with Bayer for commercialization in the U.S.
The literature review was conducted with the support and participation of the Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas, and Daré Bioscience. Based on the literature review, the article concludes that, for evaluating vaginal contraceptives, the PCT is the closest analogue available as a predictor of contraceptive effectiveness and is the best indicator of whether a test product works before it is evaluated in a contraceptive effectiveness study.
"The findings from our review clearly demonstrate that the PCT is predictive of contraceptive effectiveness, and that a test product that performs well in a PCT study carried out in the same manner as recent PCT clinical studies can be expected to demonstrate contraceptive effectiveness in a pivotal study at a level predictive of a highly effective contraceptive product," said Christine Mauck, MD, MPH, Medical Director for Daré Bioscience and co-author of the article. "We believe the Ovaprene PCT study completed by Daré last year is the most robust PCT clinical study ever conducted in the field of contraception, and the findings are encouraging in the context of other PCT studies with regard to Ovaprene's potential as an alternative to traditional hormone-based contraceptive options. As summarized in the article, other contraceptives that demonstrated PCT study results comparable to results seen with Ovaprene in last year's PCT study, went on to demonstrate six-month typical-use contraceptive effectiveness of 86-91% in their respective pivotal studies, which is similar in range to typical-use effectiveness rates of hormonal methods like pills, patches, and vaginal rings such as the NuvaRing® vaginal ring."
The accepted manuscript for the article entitled "The Postcoital Test in the Development of New Vaginal Contraceptives" is currently available in the Advance Articles section on the journal's website, or at https://doi.org/10.1093/biolre/ioaa099
Bayer and Daré Bioscience Exclusive Licensing Agreement for U.S. Commercial Rights to Ovaprene:
In January 2020, Daré announced that it entered into an exclusive licensing agreement with Bayer for U.S. commercial rights to Ovaprene. Under the agreement, Daré received an upfront payment and access to Bayer's extensive clinical and market capabilities while retaining control over Ovaprene's development and regulatory approval process. Bayer received the right to obtain exclusive rights to commercialize the product in the U.S. following completion of the pivotal clinical trial being undertaken by Daré. If Bayer, in its sole discretion, makes payment to Daré of$20 million, which Daré intends to apply to reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective. Daré will also be entitled to receive commercial milestone payments potentially totaling$310 million, in addition to double digit tiered royalties on net sales.
The PCT Study Background:
The PCT study was initially developed to assess whether cervical factors played a role in infertility and became standard practice in the evaluation of infertile couples for many decades until it was replaced in the 1990s by more predictive testing methodologies and the wider use of in vitro fertilization, which bypasses the cervical mucus-sperm interaction. The World Health Organization describes key aspects of the PCT procedure, including the timing for collection of cervical mucus after intercourse and the method of counting and characterizing sperm found in the mucus.  The PCT has been used to evaluate both chemical and mechanical barrier vaginal contraceptive products, including spermicides and diaphragms. [2, 3]
- WHO laboratory manual for the Examination and processing of human semen, 5th ed., World Health Organization, 2010, available at https://www.who.int/reproductivehealth/publications/infertility/9789241547789/en/
- A phase I randomized postcoital testing and safety study of the Caya diaphragm used with 3% Nonoxynol-9 gel, ContraGel or no gel. Mauck CK, Brache V, Kimble T, Thurman A, Cochon L, Littlefield S, Linton K, Doncel GF, Schwartz JL. Contraception. 2017 Aug;96(2):124-130.
- The Postcoital Test in the Development of New Vaginal Contraceptives. Mauck CK, Vincent KL. Biology of Reproduction, 2020 June 16; accepted manuscript available at https://doi.org/10.1093/biolre/ioaa099