In response to its posting positive results from a midstage clinical trial, shares of Evofem Biosciences (NASDAQ:EVFM), a clinical-stage biotech focused on women's sexual and reproductive health, had risen 13% as of 11:27 a.m. EST on Monday.
Evofem reported top-line results from its phase 2b AMPREVENCE trial, which was designed to test the efficacy and safety of its lead product candidate Amphora as a preventive treatment for urogenital chlamydia and gonorrhea in women.
Here are the key takeaways from the four-month study release:
- The trial met both its primary and secondary endpoints.
- The infection rate of chlamydia among women who used Amphora was 4.9%. That was 50% less than the 9.8% among women who took the placebo. The p-value was 0.024, so the results were statistically significant.
- The infection rate of gonorrhea was 0.7% in the Amphora arm, 78% lower than the 3.2% observed in the placebo arm group. The p-value was 0.03, which is also low enough to be considered statistically significant.
- The number of adverse events was 7.2% for patients who used Amphora and 7.5% for the placebo group. No serious treatment-related adverse events were reported.
Given the upbeat results, it's easy to understand why shares are flying high today.
Saundra Pelletier, Evofem's CEO, stated: "In less than one week, we have achieved two major milestones that have the potential to meaningfully impact the sexual and reproductive health of millions of women. In addition to resubmitting our New Drug Application to the U.S. FDA for Amphora for prevention of pregnancy, we also now have statistically significant evidence that Amphora can prevent acquisition of chlamydia and gonorrhea among women, two bacterial infections that are increasing at an alarming annual rate in the U.S."
The Centers for Disease Control estimate that almost 2.4 million cases of chlamydia and gonorrhea were diagnosed in 2018. What's more, gonorrhea is increasingly becoming antibiotic-resistant, so new treatment options are desperately needed.
If Amphora can go on to win FDA approval, it will likely be a top-selling drug. Evofem expects to submit the full results from the trial for presentation at an upcoming scientific meeting. The data will also be used to request an end-of-phase 2 meeting with the FDA.