Press Release
Daré Bioscience Announces New Development Program, DARE-PDM1, as a Potential First-in-Category Treatment for Primary Dysmenorrhea
DARE-PDM1 Utilizes Proprietary Hydrogel Technology for Vaginal Delivery of Diclofenac, a Nonsteroidal Anti-Inflammatory; Phase 1 Study Targeted for 2023
2022 Daré Portfolio Accomplishments Include:
Two Additional Portfolio Programs (DARE-GML and grant-funded DARE-LBT);
License Agreement with Organon to Commercialize XACIATO™;
Ovaprene® IDE Approval for Pivotal Contraceptive Efficacy Study;
Positive Phase 1/2 Data for both DARE-HRT1 and DARE-VVA1
2023 Anticipated Milestones Include:
XACIATO First Commercial Sale;
Sildenafil Cream, 3.6% for Female Sexual Arousal Disorder Phase 2b Topline Data;
Ovaprene Pivotal Study Recruitment; DARE-PDM1 Phase 1 Study
“Calendar 2022 has been an incredibly successful year for our portfolio in terms of:
1) expanding our portfolio with additional differentiated product candidates that we believe further our leadership as an accelerator of innovative products in women’s health;
2) securing a global commercialization collaboration for our first FDA-approved product, XACIATO (clindamycin phosphate) vaginal gel, 2%, a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older, which is the second commercial collaboration agreement for our portfolio (the first was entered into with Bayer in 2020 for Ovaprene); and
3) demonstrating clinical success (such as with DARE-HRT1 and DARE-VVA1) and advancing regulatory and clinical development to enable important 2023 milestones (such as the Sildenafil Cream Phase 2b topline data targeted for 2Q-2023 and Ovaprene pivotal study recruitment initiation targeted for mid-2023),” said
“As a company, we are committed to addressing unmet needs in women’s health. We believe that we have assembled a robust portfolio in women’s health and that all of our programs have the opportunity to be either first-line or first-in-category, or both,” Johnson added. “It is our belief that prioritizing women’s health is not only good for the many women lacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, because contraception, fertility, and vaginal and sexual health, our areas of focus, are compelling markets impacting millions of women and we have seen that innovation in these areas has led to commercially successful brands. Specifically, we find these market research statistics compelling: Only approximately 1% of healthcare research is invested in female-specific conditions beyond oncology, and women’s health conditions outside of oncology comprise less than 2% of the current healthcare pipeline. Yet, women’s health products outside of oncology make up 27% of the total number of blockbuster products (products that each have over
About Primary Dysmenorrhea and DARE-PDM1
Primary dysmenorrhea is defined as painful menstruation in women with normal pelvic anatomy, typically described as cramping pain in the lower abdomen before or during the menstrual period. Primary dysmenorrhea usually begins during adolescence and is a leading cause of recurrent short-term school absence in adolescent girls and a common problem in women of reproductive age. Recent market research suggests that the global market for dysmenorrhea treatment is estimated to be valued at USD
“Utilizing the same hydrogel technology found in XACIATO, and consistent with our portfolio of differentiated and novel product candidates, we are developing DARE-PDM1 to address a critical unmet medical need in women’s health,” said Dr. Annie Thurman, Medical Director of Daré Bioscience. “The most common interventions for primary dysmenorrhea include oral NSAIDs and hormonal contraceptives which often can produce undesirable side effects. By incorporating diclofenac into our proprietary hydrogel for vaginal administration, we believe we can provide a treatment option that addresses the pain-related symptoms of the condition while minimizing side effects commonly seen with use of oral NSAIDs,” continued
Portfolio Updates Previously Announced in 2022:
XACIATO™ (clindamycin phosphate) vaginal gel, 2%, FDA-approved for treatment of bacterial vaginosis in females 12 years of age and older
Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 21 million women in the
In June, Daré announced that the exclusive license agreement entered into in March 2022 with Organon (NYSE: OGN), a global women’s healthcare company, became fully effective. Under the agreement, Organon licensed global rights to XACIATO. Under the license agreement Daré received a
Ovaprene® - investigational hormone-free monthly intravaginal contraceptive
In October, Daré announced that the FDA approved an Investigational Device Exemption (IDE) application allowing Daré to proceed with a single arm, open-label pivotal contraceptive efficacy study of Ovaprene. The multi-center, single arm, non-comparative, pivotal Phase 3 study will evaluate Ovaprene’s effectiveness as a contraceptive device along with its safety and usability. If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the
In
If Ovaprene is approved by the FDA, it could be the first monthly non-hormonal contraceptive product for women and a first-in-category option for women seeking a hormone-free, self-administered and monthly birth control method.
Sildenafil Cream, 3.6% - investigational treatment for female sexual arousal disorder
In a joint communication released in November of this year, Daré and its development partner,
Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD. FSAD is the inability to reach or maintain a sufficient physical response to sexual stimulation and, of the various types of female sexual dysfunction disorders, FSAD is most analogous to erectile dysfunction (ED) in men. Sildenafil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. Market research suggests that 16% of women in the
If clinical development is successful, Sildenafil Cream, 3.6% has the potential to be the first FDA-approved FSAD treatment option.
DARE-HRT1 & DARE-VVA1 Phase 1/2 data
In April, Daré announced the initiation of a Phase 1/2 clinical study of DARE-HRT1, a novel, investigational intravaginal ring (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 following menopause. HT is used to treat the vasomotor symptoms (VMS) and genitourinary syndrome associated with menopause. Positive efficacy results from this study were announced in October, including statistically significant results for improvement in both the vasomotor and vaginal symptoms of menopause. Daré anticipates that the topline pharmacokinetics (PK) data from the study will be available and reported later in the fourth quarter of 2022.
“The levels of estradiol released from both the lower and higher dose formulations of DARE-HRT1 achieved statistically significant improvement in VMS as well as the genitourinary symptoms of menopause, and vaginal pH and maturation index,” said
The North American Menopause Society’s (NAMS) guidance on hormone therapy states 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 has the potential to be the first FDA-approved monthly IVR delivering both estrogen and progestogen hormone therapy.
Positive topline results from a Phase 1/2 clinical study of DARE-VVA1 were also announced this year, in November. The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with vulvar and vaginal atrophy (VVA). DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of hormone receptor-positive (HR+) breast cancer. Tamoxifen is a well-known and well-characterized selective estrogen receptor modulator (SERM) that has been prescribed by oncologists for decades for the treatment of breast cancer. In breast tissue, tamoxifen acts as an estrogen antagonist. In contrast, in other tissues such as vaginal tissues, tamoxifen has been reported to exert an estrogen-like response on vaginal cytology.
The DARE-VVA1 study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma PK and pharmacodynamics (PD) of DARE-VVA1. Eligible participants were randomly allocated to one of five treatment groups (approximately 4 participants per group) that evaluated four dose levels (1 mg, 5 mg, 10 mg, and 20 mg) and a placebo. Following a screening visit, DARE-VVA1 was self-administered intravaginally once a day for the first two weeks, and then twice a week for the following six weeks for a total treatment period of 56 days. Intravaginal administration of DARE-VVA1 was well tolerated and all treatment emergent adverse events were mild or moderate and equally distributed between participants randomized to study drug treatment versus placebo. DARE-VVA1 demonstrated improvements in vaginal cytology parameters and self-assessed most bothersome symptoms of VVA (vaginal dryness or pain with intercourse) that support ongoing development.
VVA is a common condition in postmenopausal women as well as women diagnosed with, or with a history of, HR+ breast cancer, who often report VVA as one of the most unpleasant side effects of their cancer treatment. The prevalence of VVA in postmenopausal breast cancer patients is estimated to be between 42 and 70 percent. Products containing estrogen are commonly used to treat VVA. However, the use of estrogen-containing products for the treatment of VVA is often contraindicated for HR+ breast cancer patients and survivors because of the concern that estrogen use will promote recurrence of disease.
There are currently no FDA-approved products labeled for VVA treatment for patients with or at risk of recurrence of HR+ breast cancer.
New Portfolio Candidates – DARE-LBT and DARE-GML
DARE-LBT - novel hydrogel formulation for delivery of live biotherapeutics
In November, Daré announced it received a grant of
DARE-GML - novel antimicrobial glycerol monolaurate
In August, Daré announced it entered into a license agreement with Hennepin Life Sciences LLC under which Daré acquired the exclusive global rights to develop and commercialize treatments delivering the novel antimicrobial glycerol monolaurate (GML) intravaginally for a variety of vaginal health conditions including bacterial, fungal, and viral infections. GML is a naturally occurring fatty acid monoester that has shown broad antimicrobial activity, killing bacteria, fungi, and viruses, and represents a new class of antimicrobials. GML has the potential to be a first-in-category multi-target antimicrobial agent.
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health.
Daré’s first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel, 2% is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. XACIATO is a clear, colorless, viscous gel, to be administered once intravaginally as a single dose. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com),
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans and expectations with respect to Daré’s product candidates, including anticipated timing for commencement and conduct of clinical trials and clinical trial data readouts, potential regulatory approval pathways, potential for FDA approval based on a single pivotal clinical study, and potential to be first-line and/or first-in-category products, expectations regarding the commercial launch of XACIATO in the
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Source: Daré
Source: Daré Bioscience, Inc.