In Development

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 investigational drug candidate EVO100 vaginal gel 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
In October 2020, Evofem initiated EVOGUARD, a pivotal Phase 3 clinical trial to evaluate the safety and efficacy of EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women. Top-line results are expected in 2022.

The Phase 2b AMPREVENCE study evaluating EVO100 for the prevention of chlamydia and gonorrhea met its primary and secondary endpoints, and the study showed that EVO100 was generally safe and well tolerated. Results of this double-blinded, placebo-controlled trial were presented at the 2020 STD Prevention Virtual Conference (view poster).

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

Indication Pre-Clinical Phase 1 Phase 2b Phase 3
Regulatory Filing Phase 3 Phase 2b Phase 1 Pre-Clinical Indication
Not Yet Filed
Prevention of Chlamydia and Gonorrhea in Women
Regulatory Filing Not Yet Filed

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

This investigational drug candidate is in development to assess its ability to:
  • Kill 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

Chlamydia/Gonorrhea Prevention Clinical Trial

EVOGUARD is a double-blind, placebo-controlled Phase 3 clinical trial designed to assess the safety and efficacy of EVO100 vaginal gel to prevent Chlamydia trachomatis and Neisseria gonorrhea infection in women. Approximately 1,730 women who had a chlamydia or gonorrhea infection in the past 4 months will be enrolled at approximately 90 sites in the United States for a 4-month interventional period, followed by a 1-month follow-up period. For more information, or to see if you qualify to take part in EVOGUARD, please visit https://www.evoguardstudy.com/ct/.

 

Expanded Access Program Policy

  • Evofem understands that some patients may wish to access investigational medicinal products that are not yet approved by FDA. The most appropriate way for patients to access our investigational products is by participating in our ongoing clinical trial(s), which are managed by clinical experts and are designed to determine whether the investigational products are safe and effective. Furthermore, these clinical studies provide insight to the mechanism of action, safety, and efficacy of the investigational product so that the benefits and risks can be appropriately understood.  The investigational new drug application process ensures treatment with the rigorous evaluation to ensure benefits outweigh the risks for the treatment of proposed use.  Patients who are interested in participating in our ongoing studies are encouraged to discuss their specific needs with their healthcare provider.

  • Information regarding our ongoing clinical trials can be accessed at www.clinicaltrials.gov.

  • Evofem understands that there may be patients interested in obtaining access to our investigational products for treatment under an Expanded Access Program, however, at this stage of development of our products, there is insufficient clinical data to support expanded access use for treatment of serious or life-threatening diseases or manufacture for this purpose. Hence Evofem does not currently provide access to our investigational products through expanded access.

  • In accordance with the 21st Century Cures Act, this policy may be revised at any time and will be shared with the public on the Company sponsored website. If you have any additional questions, please reach out to your healthcare provider or contact medicalinformation@evofem.com or 1-833 -383-6246 (833-EVFMBIO).