Evofem Completes Enrollment in EVOGUARD Phase 3 Clinical Trial of EVO100 for the Prevention of Chlamydia and Gonorrhea in Women
SAN DIEGO, March 4, 2022 /PRNewswire/ — Evofem Biosciences Inc., (Nasdaq: EVFM) today announced that it has completed its listing in EVOGUARDthe registrational Phase 3 clinical trial evaluating EVO100 (the investigational name of Phexxi® (lactic acid, citric acid, potassium bitartrate)) for two potential new indications: prevention of chlamydia infection in women and prevention of urogenital gonorrhea infection in women.
The design of the clinical trial initially envisaged a recruitment of 1730 participants. Due to the high level of demand to participate in the study, researchers recruited 1,903 participants, providing the opportunity for a more complete understanding of the trial data and results.
Main data of EVOGUARD are expected in the second half of 2022.
“I see a significant increase in the number of chlamydia and gonorrhea infections in my patients,” said Dr. Todd Chappell, EVOGUARD trial investigator and practicing obstetrician and gynecologist. “There is a significant need for new effective and safe ways to prevent these infections, and Phexxi, a potential preventative option against these contagious diseases, may offer women some form of protection against these infections.”
The CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred in 2018 alone..1 The number of reported cases is lower than the total estimated number because those infected are often unaware of their infection and do not seek treatment. Almost 60% of women infected with chlamydia have no symptoms.2 Chlamydia is the most commonly reported bacterial infection in the United States and can infect both men and women. It can cause serious and permanent damage to a woman’s reproductive system and make it difficult or impossible for a woman to become pregnant later in life.
Chlamydia and gonorrhea are thought to be responsible for one-third to one-half of pelvic inflammatory disease (PID) cases. PID can cause serious long-term problems, including infertility, ectopic pregnancy, and chronic pelvic pain.3
The completion of registration comes less than a month after the U.S. Food and Drug Administration (FDA) granted a Qualified Infectious Disease Product (QIDP) designation to EVO100 (the investigational name of Phexxi) for the prevention of urogenital chlamydial infection in women. The QIDP designation is intended to encourage the development of new products for the treatment of serious or life-threatening infections. A drug or product in development that receives this designation qualifies for an additional five years of market exclusivity after FDA approval for that indication.
“Complete registration for EVOGUARD marks an important milestone for Evofem and underscores our continued efforts to evaluate this potential product, the first and only in its class, in women for the prevention of chlamydia and gonorrhea infections,” said Saundra Pelletier, CEO of Evofem Biosciences. “As we speak with women and observe the market environment, we recognize the need to educate the public about these two sexually transmitted infections and strive to seize this opportunity and expand our role to help women control and protect their sexual health. If approved, Evofem may have an impact beyond preventing unplanned pregnancies and creating a significant new market opportunity. »
The FDA previously granted EVO100 Fast Track designation for the prevention of chlamydia and gonorrhea, and in 2017 granted QIDP designation to EVO100 for the prevention of gonorrhea in women.
Evofem would like to thank all those who participate and lead the EVOGUARD trial, and all other ongoing research sponsored by Evofem.
2 Patel, Chirag G et al. “The proportion of young women tested for chlamydia who had urogenital symptoms in physicians’ offices.” Sexually transmitted diseases flight. 45.9 (2018): e72-e74. doi:10.1097/OLQ.0000000000000858
Phexxi is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex. For more information about Phexxi, talk to your healthcare provider and see complete product information at www.phexxi.com.
Important Safety Information
- Rare cases (0.36%) of bladder and kidney infections have been reported. If you have a history of urinary tract problems that keep coming back, you should not use Phexxi.
- Contact your health care provider if you experience genitourinary side effects such as vaginal burning, itching, discharge, genital discomfort (including in male partners), yeast infection, urinary tract infection or bacterial vaginosis.
- Phexxi does not protect against sexually transmitted infections, including HIV.
Please report side effects by contacting Evofem Biosciences toll-free at 1-833-EVFMBIO or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Intended for US residents only.
About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) develops and markets innovative products to address the unmet sexual and reproductive health needs of women, including female-controlled, hormone-free contraception and protection against certain sexually transmitted infections. transmissible (chlamydia and gonorrhea). The company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, prescription vaginal contraceptive gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each sexual intercourse. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
This press release contains “forward-looking statements”, within the meaning of the safe harbor for forward-looking statements provided for by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including , without limitation, statements relating to the timing and outcome of the confirmatory Phase 3 trial, any submission or approval of Phexxi to or by the FDA for the prevention of chlamydia and gonorrhea, and the size of the market opportunity in the prevention of chlamydia and gonorrhea. A variety of factors could cause actual results to differ materially from those discussed or implied by the forward-looking statements, including market and other conditions, and you are cautioned not to place undue reliance on such forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could adversely affect the value of the assets and businesses of Evofem Biosciences, are disclosed in the documents filed by the Company with the SEC, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 4, 2021. All forward-looking statements are expressly qualified in their entirety by these factors . The Company undertakes no obligation to update forward-looking statements, except as required by law.
Evofem Biosciences, Inc.
Evofem Biosciences, Inc.
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