| Site | |
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| Stage of funding: | Completed |
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| Therapeutic group: | Gynecology |
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| Type: | Drug |
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Description
Evofem Biosciences develops and anticipates commercializing innovative products that support and promote women as the primary healthcare consumer. Evofem is currently identifying and developing new and novel products to specifically address unmet needs in the areas of women's sexual and reproductive health, the prevention of acquisition of sexually transmitted infections and products that address or promote general health and wellbeing.
PRODUCTS
Multipurpose Prevention Technology (MPT) In Development
Evofem Biosciences is dedicated to developing a portfolio of innovative therapeutic solutions to meet the evolving sexual and reproductive health needs of millions of women globally, including contraception and the prevention of STIs. Our goal is to create woman-controlled, easy-to-use and accessible products approved as MPTs. Because when a woman is in complete control today, she is in greater control of tomorrow.
Amphora® for the prevention of pregnancy
Amphora
® - has been designed as a contraceptive with unique attributes to fit a woman’s needs:
- Hormone free: for those who have a contraindication for or are uncomfortable adding hormones to their body
- Woman-controlled: empowers women to control over their contraception choice
- Use as needed: no need to take a pill every day or have an implant; can be used up to one hour before sexual intimacy
- Easy-to-use: self-applied contraception in an easy-to-use pre-filled applicator.
On Phase 3.
Antimicrobial Drug Product for the Prevention of Sexually Transmitted Infections (STIs)
Our antimicrobial drug product has received an Qualified Infectious Disease Product (QIDP) status
It is designed to reduce certain vaginal infections by:
- Creating an environment that is a conducive to maintaining healthy vaginal flora but is detrimental to the growth and proliferation of harmful bacteria
- Using a different mechanism of action that may help to address drug resistance concerns/
On Phase 2.
Antimicrobial drug product to prevent the reoccurrence of Bacterial Vaginosis (BV)
Our antimicrobial drug product has been granted QIDP status
It is in development to assess its ability to:
- Kill many BV-associated pathogenic bacteria which has been demonstrated In Vitro data
- Balance vaginal pH, thereby supporting normal vaginal flora and eliminating odor associated with BV
On Phase 1.
CLINICAL TRIALS
Prevention of Pregnancy
The AMPOWER Clinical Research Study (AMP002)
The AMPOWER study is our second pivotal, Phase 3 clinical trial designed to assess the effectiveness of Amphora® in preventing pregnancy and to evaluate its safety over 7 menstrual cycles of use in women who are using no other forms of birth control. Amphora® is a novel, non-hormonal birth control designed to maintain the pH of the vagina to inhibit sperm motility and to form a layer of gel over the vagina and cervix, preventing sperm from reaching an egg. The study will enroll approximately 1350 women at about 100 study centers in the US.
Antimicrobial Effects
Chlamydia/Gonorrhea Prevention Clinical Trial (EVO-003)
EVO-003 is a Phase 2b/3 clinical trial designed to assess the ability of our antimicrobial drug product to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint). EVO-003 is a double-blind, placebo controlled study in approximately 850 women at about 20 sites in the United States. Approximately 850 women will be enrolled for a 4-month interventional period followed by a 1-month follow-up period.
Reduction in the Recurrence of Bacterial Vaginosis (BV) Clinical Trial
This clinical trial is a Phase 2b/3 study designed to assess the ability of our antimicrobial drug product to reduce the recurrence of BV. It is a double-blind, placebo controlled study in approximately 100 women at about 4 sites in the United States. Women with BV will be treated with standard of care then randomized to active or placebo arms. The drug will be administered once-weekly for up to 16 weeks followed by at least of 12 weeks of follow-up.
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