Daré Bioscience has announced positive topline results from its Phase 1 clinical trial of DARE-HRT1. DARE-HRT1 is a novel IVR designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy (HT) regimen to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. The topline data from the study support DARE-HRT1’s potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format to treat both VMS as well as vaginal symptoms of menopause. The North American Menopause Society’s guidance on hormone therapy includes that dosing estrogen and progestogen in combination may offer important benefits to women and NAMS observed that non-oral routes of administration may offer advantages over orally administered therapies.
“DARE-HRT1 demonstrated the ability to deliver two different active pharmaceutical ingredients, in this case two bio-identical hormones, reliably over a 28-day period. Generating positive topline data in our first Phase 1 study utilizing our novel IVR technology represents an important clinical achievement for Daré and for the IVR platform,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “For some women, hormone therapy is a highly effective treatment for the symptoms associated with menopause, such as hot flashes and vaginal dryness, and may also prevent bone loss and fracture. The delivery of hormone therapy over 28 consecutive days with no daily intervention supports DARE-HRT1’s potential to be a first-in-category option offering ease-of-use and consistent dosing to women suffering from menopausal symptoms. There are currently no FDA-approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks.”
“We are highly encouraged by these Phase 1 data as they demonstrate DARE-HRT1’s ability to achieve our dual release objectives,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “In addition to delivering hormone therapy, we believe the IVR technology used in DARE-HRT1 is an important platform technology with the potential to offer a versatile vaginal drug delivery solution to address a variety of unmet needs in women’s health through its ability to release one or more drugs at desired rates over time and with the added benefit of convenience.”
The IVR technology used in DARE-HRT1 was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Unlike other vaginal ring technologies, Daré’s IVR drug delivery technology is designed to release more than one active ingredient via a solid ethylene vinyl acetate polymer matrix without the need for a membrane or reservoir to contain the active drug or to control the release, allowing for sustained drug delivery.