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Evofem Biosciences announces positive top-line data results of phase 3 study of Amphora for hormone-free birth control.
Evofem (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health.
Evofem’s lead product candidate, Amphora®, is a Multipurpose Vaginal pH Regulator (MVP-R) designed to regulate vaginal pH to within the normal range of 3.5 to 4.5. This maintains an acidic environment which is inhospitable to sperm as well as certain viral and bacterial pathogens associated with sexually transmitted infections, but is integral to the survival of healthy bacteria in the vagina.
On December 17, 2018, Evofem reported positive top-line results of AMPOWER, a Phase 3 clinical trial of Amphora for prevention of pregnancy. The top-line data demonstrate 86.0% efficacy with typical use, which met the primary endpoint of this study, and 98.7% efficacy when Amphora was correctly used as directed. The Company expects:
- To re-submit the Amphora New Drug Application (NDA) in Q2 2019;
- FDA decision on NDA in Q4 2019 (six-month review);
- To commercialize Amphora in early 2020 as the first and only hormone-free, woman-controlled, ‘only when she needs it’ birth control method (assuming approval).
The Company is actively enrolling patients in a double-blinded placebo-controlled Phase 2b clinical trial (AMPREVENCE) to evaluate Amphora to prevent of urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. This clinical trial is designed to enroll up to 844 women at approximately 50 centers in the United States for a four-month interventional period and subsequent one-month follow-up period.
The CDC reported in August 2018 that rates of syphilis, gonorrhea and chlamydia climbed for the fourth consecutive year in the United States. Nearly 2.3 million U.S. cases of these STDs were diagnosed in 2017 (preliminary data), an increase of over 200,000 cases over the prior year.1
Evofem’s second product candidate is a MVP-R to reduce the recurrence of bacterial vaginosis (BV), which is caused by an imbalance of a woman’s vaginal bacteria, leading to unpleasant odor and abnormal vaginal discharge. The Company recently completed a Phase 1 trial, and is currently designing a Phase 2b trial for this indication.
1Centers for Disease Control and Prevention (2018): STD Preliminary Data Accessed August 2018.