Daré Bioscience is gathering steam—the women’s health player snapped up a microchip-based implant that could become a programmable, long-term contraceptive tool and unveiled positive data for its nonhormonal contraceptive ring, setting it up for pivotal trials in 2020.
It’s picking up the implant technology in its acquisition of Microchips Biotech, a Gates Foundation-backed startup that had tested it in people with osteoporosis. Originally developed in Bob Langer’s lab at MIT, the implant was designed to store and deliver hundreds of doses of medication over the course of months or even years. The idea is to be able to program it wirelessly, so the patient can choose to stop and restart contraception as needed.
There are already long-acting contraceptives on the market, such as the matchstick-like birth control implant and the intrauterine device (IUD). But the company found in its research that women often get these removed early, that is, before the end of their therapeutic window, Daré CEO Sabrina Martucci Johnson told FierceMedTech.
“They’re not getting them removed because of side effects, or because they don’t like it,” Johnson said. “It’s because their needs change.”
The Microchips technology could become a reversible form of birth control for people who want the high effectiveness and low maintenance of an implant but who also want the ability to stop or start contraception without undergoing multiple device insertion and removal procedures.
In the stock-for-stock merger, Daré will issue 3 million shares of its common stock to Microchips’ stockholders. If all goes well, it could hand over as much as $101.5 million in development, regulatory, funding and commercial development milestones in addition to royalty payments. The deal is slated to close by next Friday, according to a Securities and Exchange Commission filing.
The new technology joins a handful of contraceptive programs in Daré’s pipeline, which also includes treatments for bacterial vaginosis and female sexual arousal disorder. One of the company’s other prospects is Ovaprene, a nonhormonal contraceptive ring that prevented “essentially all sperm” from entering the cervical canal in a pre-pivotal study.
The study enrolled 38 women in what’s called a postcoital test, which is used to gauge the effectiveness of hormone-free contraceptives. It involves looking at a sample of cervical mucus under a microscope and counting how many sperm made it there. Each sample is divided into nine sections—called high power fields, or HPFs—and then the number of progressively motile sperm, or live, forward-moving sperm, are counted in each section. These figures were then averaged for each woman and across the trial.
The study followed women through various cycles, including a baseline cycle, during which no contraceptive was used, as well as cycles during which the women wore Ovaprene or used a diaphragm. Of the 26 women who had completed at least one Ovaprene cycle, the mean number of sperm per section was 0.48—a fraction of 5-sperm threshold needed for success. This was down from a baseline mean of about 27 sperm per section.
“These data are highly significant and demonstrate that Ovaprene prevented almost all sperm from entering the cervical canal, a surrogate marker for highly effective contraceptives,” said Christine Mauck, M.D., medical director for Daré Bioscience, in a statement Tuesday. “Other contraceptives that demonstrated no motile sperm in the cervical mucus in PCT clinical studies of similar size, went on to demonstrate typical-use contraceptive effectiveness of 86-91% in pivotal studies evaluating pregnancy rates over six-month periods, similar in range to typical-use effectiveness rates of hormonal methods like pills, patches, and vaginal rings such as the NuvaRing vaginal ring.”
Next up, the company will file an Investigational Device Exemption with the FDA so it can carry out a pregnancy study as its pivotal trial. The pre-pivotal study tested the device in women who had undergone tubal ligation and were not at risk of becoming pregnant.
Daré has some ideas of what a pivotal study might look like, based on the regulatory paths for other contraceptive products.
“Obviously, there has never been a product like Ovaprene. Everything else reviewed has been ‘in-the-moment'—condoms, spermicides, diaphragm—this would be the first discussion of something a woman would wear constantly over the course of a month,” Johnson said. “It will finally give us a chance to have an Ovaprene-specific conversation about what the study will look like.”
However that conversation pans out, Johnson thinks Daré will be on track to start that study sometime in 2020.