EVO100 Gel
Evofem is collaborating with Orion Biotechnology to evaluate the compatibility and stability of Orion’s novel CCR5 antagonist, OB-002, in Phexxi® with the goal of developing a Multipurpose Prevention Technology (MPT) product candidate for indications including the prevention of human immunodeficiency virus (HIV) in women. This collaboration will focus on determining compatibility and stability of OB-002 in Phexxi® and is expected to yield results in the third quarter of 2022. Enrollment for the Phase 3 EVOGUARD trial, a Phase trial to evaluate the safety and efficacy of EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection in women, is complete and topline data is expected in the second half of 2022. Additionally, EVO100 has received Qualified Infectious Disease Product (QIDP) Designation for the prevention of urogenital chlamydia infection in women.
Development Stage:
Clinical – Phase 3 Trial (C3)
Hormonal/Non-Hormonal:
Non-Hormonal
Delivery Route & Method:
Intravaginal - Gel-Vaginal
Mechanism of Action:
Vaginal pH modulator
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):
- Pregnancy
- Chlamydia and gonorrhea under clinical investigation
Useful Links:
- http://www.evofem.com/in-development/
- http://www.evofem.com/our-product/
- https://clinicaltrials.gov/ct2/show/NCT01306331?term=Amphora+Gel&rank=1
- https://www.evoguardstudy.com/ct/
- https://clinicaltrials.gov/ct2/show/NCT03243305?term=Amphora+Gel&draw=2&rank=4
- https://clinicaltrials.gov/ct2/show/NCT04553068?term=EVO100&draw=2&rank=1