Evofem Announces Completion of Last Subject Last Visit (LSLV) in Registration Phase 3 “EVOGUARD” Trial Evaluating Phexxi® for the Prevention of Chlamydia and Gonorrhea in Women
— First line reading of expected data in October 2022 —
— U.S. regulatory submission planned for the first half of 2023 —
— Phexxi could become the first-ever female-controlled prophylactic for the prevention of chlamydia and gonorrhea —
SAN DIEGO, 1st of August2022 /PRNewswire/ — Evofem Biosciences, Inc., (Nasdaq: EVFM) announced today that the last subject completed its last visit in EVOGUARD, the Company’s registrational Phase 3 trial evaluating the efficacy and safety of Phexxi® (lactic acid, citric acid, potassium bitartrate) for the prevention of chlamydia and gonorrhea in women. There are no approved prescription pharmaceuticals to prevent these sexually transmitted infections (STIs).
Main data of EVOGUARD is expected in October 2022. Evofem expects positive results to allow the company to submit regulatory applications in the first half of 2023 to the U.S. Food and Drug Administration (FDA) to expand Phexxi’s approved indications to include the prevention of urogenital chlamydia and gonorrhea in women. Phexxi is currently approved in the United States for the prevention of pregnancy.
“This is a major milestone for Evofem and brings us closer to our goal of providing women with a safe and effective prophylactic measure against chlamydia and gonorrhea, the two most commonly reported sexually transmitted infections in the United States,” said Saundra Pelletier, CEO of Evofem. “We believe these potential new indications represent a significant shareholder benefit beyond the multi-billion dollar contraceptive market that we continue to increasingly penetrate with Phexxi for hormone-free contraception.”
20% of people in the United States had an STI on any given day in 2018, according to a 2021 study in the journal Sexually transmitted diseases. The CDC estimates that 4.0 million and 1.6 million new cases of chlamydia and gonorrhea, respectively, occurred that year.1 People who are infected are often unaware of it and do not seek treatment for their infections. 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.
EVOGUARD builds on the positive and statistically significant results of AMPREVENCE, the randomized, double-blind, placebo-controlled phase 2b/3 study evaluating Phexxi for the prevention of chlamydia and gonorrhea. AMPERVENCE met its primary and secondary endpoints and showed the product to be generally safe and well tolerated.
The FDA has granted Fast Track designation and Qualified Infectious Disease Product (QIDP) designation to Evofem’s product candidate for the prevention of chlamydia and gonorrhea in women.
The Fast Track program facilitates the accelerated development and review of new drugs or biologics intended to treat serious or life-threatening conditions and to demonstrate the potential to address unmet medical needs. The goal is to get important new drugs to the patient sooner.
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.
Evofem is grateful to the investigators and study coordinators at more than 100 participating study centers across the United States, as well as the 1,903 women who participated in this landmark study.
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 hormone-free, female-controlled contraception and protection against 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. The company plans to release key data from its Phase 3 registration this fall EVOGUARD clinical trial evaluating Phexxi for two potential new indications – prevention of chlamydia and prevention of gonorrhea in women. Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem Biosciences, Inc.
Phexxi is an on-demand method of birth control used to prevent pregnancy. Phexxi is not effective when used after sex.
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 healthcare 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.
For more information about Phexxi, talk to your healthcare provider and see complete product information at www.phexxi.com. 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.
This press release contains “forward-looking statements”, within the meaning of the safe harbor for forward-looking statements contemplated by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including including, without limitation, Phexxi’s label expansion, any FDA approvals of new indications and the resulting effect on shareholder value, valuations and judgments regarding Evofem, its products, its product candidates and their development, and demand for Evofem’s products and product candidates. A variety of factors could cause actual results to differ materially from those discussed or implied by the forward-looking statements, and you are cautioned not to place undue reliance on such forward-looking statements, which speak 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, 2021, filed with the SEC on March 10, 2022 and its Quarterly Report on Form 10-Q filed with the SEC the May 10, 2022. 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.
- 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)
SOURCEEvofem Biosciences, Inc.