Daré, a leader in women’s health innovation has recently announced completion of patient recruitment in its Phase 1 clinical trial of DARE-HRT1 being conducted through its wholly owned subsidiary in Australia.
DARE-HRT1 is a novel intravaginal ring (IVR) designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period. It is being developed for the treatment of vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause as part of a hormone therapy regimen.
The randomized Phase 1 study is designed to evaluate the pharmacokinetics (PK) of DARE-HRT1 in approximately 30 healthy, post-menopausal women. The primary objective of the study is to describe the PK parameters of two different dose combinations over 28 days. Secondary endpoints of the study include assessing the safety and tolerability of DARE-HRT1 and comparing the exposure of estradiol, estrone, and progesterone of DARE-HRT1 over 28 days against a daily combination of oral estrogen (Estrofem®) and oral progesterone (Prometrium®).
“The IVR drug delivery technology used in DARE-HRT1 is an important platform for Daré as we believe it offers a versatile drug delivery system in women’s health with the potential to improve convenience and outcomes,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience. “The objective of this Phase 1 study of DARE-HRT1 is to evaluate the ability of DARE-HRT1 to achieve its dual release objectives, as well as the ability of the IVR technology to release two different active drugs at two different rates.”
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.
Hormone therapy is considered the most effective treatment for vasomotor symptoms, commonly referred to as hot flashes, and the genitourinary syndrome of menopause, and has been shown to prevent bone loss and fracture. There are currently no FDA-approved IVRs that deliver bio-identical progesterone in combination with bio-identical estradiol. As such, DARE-HRT1 has the potential to be a first-in-category product that offers monthly convenience for women. Daré intends to leverage the existing safety and efficacy data on the active ingredients in DARE-HRT1, estradiol and progesterone, to utilize the FDA’s 505(b)(2) pathway to obtain marketing approval of DARE-HRT1 in the U.S.
The Phase 1 study of DARE-HRT1 is being conducted by Daré’s wholly-owned Australian subsidiary at specialty women’s health sites in Australia. Currently, Australia’s research and development tax incentive (R&DTI) gives 43.5% of every dollar spent by eligible companies on eligible R&D activities back to those companies in a cash payment. Daré’s subsidiary has and intends to continue to apply for the maximum refundable cash credit available under the Australian R&DTI program for eligible study costs incurred.
Daré anticipates reporting topline data from this study in the second quarter of 2021.