In Development

Introducing

Products in Development

Evofem Biosciences® is dedicated to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. Evofem is leveraging its proprietary vaginal pH modulator to develop product candidates for multiple indications, including the prevention of urogenital transmission of chlamydia and gonorrhea in women, and recurrent bacterial vaginosis.

EVO100 – an investigational candidate for the prevention of urogenital chlamydia and gonorrhea in women

Our drug candidate EVO100 has been granted Fast Track Designation for the prevention of chlamydia in women and Qualified Infectious Disease Product (QIDP) Designation for the prevention of gonorrhea in women by the U.S. Food and Drug Administration.

It is designed to reduce certain vaginal infections by:
  • Balancing vaginal pH, thereby maintaining healthy vaginal flora and creating an environment that is detrimental to the growth and proliferation of harmful bacteria
  • Using a different mechanism of action that may help to address drug resistance concerns
The Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea met its primary and secondary endpoints, and EVO100 was generally safe and well tolerated.

Indication Pre-Clinical Phase 1 Phase 2b Phase 3
Regulatory Filing Phase 3 Phase 2b Phase 1 Pre-Clinical Indication
Not Yet Filed
STIs
Regulatory Filing Not Yet Filed

Vaginal pH modulator for the prevention of recurrent Bacterial Vaginosis (BV)

It is in development to assess its ability to:
  • Kill many BV-associated pathogenic bacteria which has been demonstrated in vitro
  • Balance vaginal pH, thereby supporting normal vaginal flora and eliminating odor associated with BV
IndicationPre-ClinicalPhase 1Phase 2Phase 3
Regulatory FilingPhase 3Phase 2Phase 1Pre-ClinicalIndication
Not Yet Filed
BV
Regulatory Filing Not Yet Filed

These products have not been approved for marketing by the U.S. Food and Drug Administration or any other regulatory agency.

Clinical Trials

Antimicrobial Effects

Chlamydia/Gonorrhea Prevention Clinical Trial
(AMPREVENCE)

AMPREVENCE is a double-blind, placebo controlled Phase 2b clinical trial designed to assess the ability of EVO100 to prevent urogenital acquisition of Chlamydia trachomatis (primary endpoint) and Neisseria gonorrhea (secondary endpoint) in women. Approximately 850 women will be enrolled at about 50 sites in the United States for a 4-month interventional period followed by a 1-month follow-up period. Enrollment in AMPREVENCE was completed in March 2019, and top-line results were reported in December of 2019. The study met its primary and secondary endpoints, and EVO100 was generally safe and well tolerated.