New Data on EVO100 for the Prevention of Chlamydia and Gonorrhea in Women to be Presented at ISPOR 2021

Rhea-AI Summary

Evofem Biosciences (NASDAQ: EVFM) announced research findings on its investigational drug EVO100 aimed at preventing chlamydia and gonorrhea in women. These findings will be presented at the Virtual ISPOR 2021 conference from May 17 to 20, 2021. The study involved 21 women and highlighted the significance of product satisfaction and its correlation with adherence to EVO100. The pivotal Phase 3 trial, EVOGUARD, is ongoing with over 80 activated sites, expecting to complete enrollment by year-end 2021. Positive results may lead to a New Drug Application to the FDA by late 2022.

Positive

• EVO100 demonstrated statistically significant efficacy in reducing chlamydia and gonorrhea infections in prior studies.
• Phase 3 clinical trial EVOGUARD is actively enrolling participants with over 80 sites activated.
• EVO100 received Fast Track designation and QIDP status from the FDA, facilitating expedited development and potential marketing exclusivity.

Negative

• None.

SAN DIEGO, May 17, 2021 /PRNewswire/ -- Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced that new research on its investigational drug EVO100 for the prevention of chlamydia and gonorrhea in women will be highlighted in a poster presentation at the annual meeting of the Professional Society for Health Economics and Outcomes Research, Virtual ISPOR 2021, which will be held May 17 to 20, 2021. 

Abstract:	108785
Title:	Assessing the Understandability and Importance of Patient Reported Outcomes Impacting Adherence and Outcomes of a Non-Hormonal Vaginal Microbicide to Protect Against Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (GC)
Authors:	Robert Morlock, PhD; Lalitha Aiyer, MD, MS, MBA, FAIHM; Kelly Culwell, MD, MPH, FACOG; Brandon Howard, PhD
Date:	Tuesday, May 18, 2021

Qualitative research was conducted among 21 women with previous experience with EVO100. The study objective was to assess the understandability and importance of questions/instruments used to assess product and global sexual satisfaction in the Phase 2b clinical study EVO-003 (AMPREVENCE), which met its primary and secondary efficacy endpoints with statistically significant reductions in the risk of chlamydia and gonorrhea infections.

Participant interviews explored the concepts of sexual satisfaction and understandability of the Female Sexual Function Index (FSFI) global sexual satisfaction and product satisfaction questions in AMPREVENCE. Patients were also asked about the importance of a microbicide to protect against infection and understanding the impact on sexual satisfaction.  

Participants reported that adherence with use of EVO100 was related to product satisfaction and the impact on global sexual satisfaction as well as efficacy. All participants indicated that this information was important to know for women considering a microbicidal vaginal gel like EVO100.

Abstracts have been published in the May 2021 issue of Value in Health¹, the international journal of ISPOR. The poster is available to registered Virtual ISPOR 2021 attendees at https://virtualispor2021.secure-platform.com/a/organizations/main/home and will be available following the conference at https://www.evofem.com/posters-and-publications/.  

Enrollment is underway in EVOGUARD, the pivotal Phase 3 clinical trial of EVO100 for prevention of chlamydia and gonorrhea in women. All 90 planned study centers have been identified and more than 80 sites have been activated. The Company expects to complete enrollment by year-end 2021 and to report top-line data in mid-2022. Positive outcomes could support submission of a New Drug Application to the FDA for these potential indications by the end of 2022.

EVO100 has been granted Fast Track designation from the FDA for the prevention of urogenital chlamydia and urogenital gonorrhea in women. Fast Track designation is designed to facilitate the development and expedite the review of new therapies to treat serious conditions and fill unmet medical needs.

Additionally, the investigational drug is designated a Qualified Infectious Disease Product (QIDP) by the FDA for the prevention of gonorrhea in women. A drug that receives QIDP designation may qualify for an additional five years of marketing exclusivity.

About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is a commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs). The Company launched its first FDA-approved commercial product, Phexxi^® (lactic acid, citric acid and potassium bitartrate) contraceptive vaginal gel, in the United States in September 2020. For more information, please visit www.evofem.com.

Phexxi^® is a registered trademark of Evofem Biosciences, Inc.

Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these 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 impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 4, 2021. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

References

1. Morlock R et al. Assessing the Understandability and Importance of Patient Reported Outcomes Impacting Adherence and Outcomes of a Non-Hormonal Vaginal Microbicide to Prevent and Protect Against Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC). Value in Health, Volume 24, Issue 5, S1 (May 2021)

 

Investor Relations Contact Amy Raskopf araskopf@evofem.com Mobile: (917) 673-5775

Media Contact Ellen Thomas ethomas@evofem.com Mobile: (718) 490-3248

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SOURCE Evofem Biosciences, Inc.

FAQ

What did Evofem Biosciences present at the ISPOR 2021 conference?

Evofem presented research on EVO100, an investigational drug for preventing chlamydia and gonorrhea in women.

When is the EVOGUARD trial for EVO100 expected to complete enrollment?

Enrollment for the EVOGUARD trial is expected to be completed by the end of 2021.

What designations has EVO100 received from the FDA?

EVO100 has received Fast Track designation and Qualified Infectious Disease Product (QIDP) status from the FDA.

What are the potential outcomes of the EVOGUARD trial?

Positive outcomes could support a New Drug Application submission to the FDA by the end of 2022.

Why is patient satisfaction important for EVO100?

Patient satisfaction is linked to adherence, which is crucial for the effectiveness of EVO100 in preventing infections.