Benzinga | Apr 27, 2021 08:05AM EDT

Dar Bioscience Announces Ovaprene Novel Investigational Hormone-Free Contraceptive Poster Presentation At 2021 Annual Clinical And Scientific Meeting Of American College Of Obstetricians And Gynecologists

Dar? Bioscience, Inc. (NASDAQ:DARE), a leader in women's health innovation, today announced that data from the Company's postcoital test (PCT) clinical study of its novel investigational hormone-free monthly intravaginal contraceptive, Ovaprene, will be presented at the 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. The meeting will be conducted virtually from April 30 - May 2, 2021.



The poster will present topline results from the Ovaprene PCT clinical study, a pre-pivotal, multi-center, open-label, non-significant risk device trial. In the PCT study, Ovaprene prevented essentially all progressively motile sperm from entering the cervical canal (mean 0.48, median 0.00, per high powered field), a surrogate marker for contraceptive effectiveness. 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. If approved, Ovaprene could be the first monthly non-hormonal prescription contraceptive product addressing an important unmet need in the contraceptive method mix.

"Market demographic data suggest there is a growing segment of women considering alternatives to hormonal contraceptive methods and it has already been established that there is a large segment of women who choose monthly contraceptive vaginal rings for the convenience of a non-daily option," said Christine Mauck, MD, Medical Director for Dar? Bioscience. "These PCT clinical study data are highly encouraging and give us confidence to move Ovaprene into the next stage of clinical development, a pivotal contraceptive effectiveness study, following our Investigational Device Exemption submission to the FDA planned for later this year."

"I believe this study was the most robust PCT clinical study ever conducted in the field of contraception and these findings are encouraging with regard to Ovaprene's potential as an alternative to traditional hormone-based options. I am honored to present results from the PCT study at the ACOG's annual meeting," commented Andrea Thurman, MD, Professor of OBGYN at CONRAD/Eastern Virginia Medical School and a principal investigator in the Ovaprene PCT clinical study.

The ePoster entitled Successful Postcoital Test Results of a New Monthly Hormone-Free Vaginal Contraceptive, authored by Andrea Thurman, MD, Jeffrey Baker, MD, Jeffrey Jensen, MD, MPH, Courtney Schreiber, MD, MPH, Nadene Zack, MS, Christine Mauck, MD, MPH, will be presented virtually by Andrea Thurman, MD and will be available to meeting attendees on the ACOG website at https://www.acog.org, beginning April 30, 2021.