EVO100 Gel
The Phase 2b study evaluating EVO100 Gel for the prevention of chlamydia and gonorrhea met its primary and secondary endpoints, and was generally safe and well tolerated. It has been granted Fast Track Designation for the prevention of urogenital chlamydia and gonorrhea in women and Qualified Infectious Disease Product (QIDP) Designation for the prevention of urogenital gonorrhea in women by the U.S. Food and Drug Administration (FDA). 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 and gonorrhea infection in women. Top-line results are expected in 2022. As of 2020, Phase 3 trials for the contraceptive indication are complete and has been approved in the United States by the FDA under the brand name Phexxi™.
Development Stage:
Clinical – Phase 3 Trial (C3)
Hormonal/Non-Hormonal:
Non-Hormonal
Delivery Route & Method:
Topical - Gel-Vaginal
Mechanism of Action:
Vaginal pH regulation
Developer:
- Evofem Biosciences, Inc.
Funding:
- Evofem Biosciences, Inc.
Funding Mechanism:
The Phase 3 EVOGUARD study is funded in part by a strategic investment in Evofem by Adjuvant Capital, LLC.
Active Ingredient(s):
- Citric Acid
- L-lactic Acid
- Potassium Bitartrate
Product Indication(s):
- Chlamydia
- Gonorrhea
- Pregnancy