What occurred

In response to its posting optimistic outcomes from a midstage medical trial, shares of Evofem Biosciences (NASDAQ:EVFM), a clinical-stage biotech centered on girls’s sexual and reproductive well being, had risen 13% as of 11:27 a.m. EST on Monday.

So what

Evofem reported top-line outcomes from its part 2b AMPREVENCE trial, which was designed to check the efficacy and security of its lead product candidate Amphora as a preventive therapy for urogenital chlamydia and gonorrhea in girls.

Listed below are the important thing takeaways from the four-month research launch:

  • The trial met each its main and secondary endpoints.
  • The an infection charge of chlamydia amongst girls who used Amphora was 4.9%. That was 50% lower than the 9.8% amongst girls who took the placebo. The p-value was 0.024, so the outcomes have been statistically important.
  • The an infection charge of gonorrhea was 0.7% within the Amphora arm, 78% decrease than the three.2% noticed within the placebo arm group. The p-value was 0.03, which can be low sufficient to be thought-about statistically important.
  • The variety of antagonistic occasions was 7.2% for sufferers who used Amphora and seven.5% for the placebo group. No severe treatment-related antagonistic occasions have been reported. 
Scientists working in lab

Picture supply: Getty Photographs.

Given the upbeat outcomes, it is easy to know why shares are flying excessive {today}.

Now what

Saundra Pelletier, Evofem’s CEO, said: “In lower than one week, we’ve achieved two main milestones which have the potential to meaningfully affect the sexual and reproductive well being of tens of millions of ladies. Along with resubmitting our New Drug Utility to the U.S. FDA for Amphora for prevention of being pregnant, we additionally now have statistically important proof that Amphora can stop acquisition of chlamydia and gonorrhea amongst girls, two bacterial infections which can be growing at an alarming annual charge within the U.S.”

The Facilities for Illness Management estimate that just about 2.Four million circumstances of chlamydia and gonorrhea have been identified in 2018. What’s extra, gonorrhea is more and more changing into antibiotic-resistant, so new therapy choices are desperately wanted.

If Amphora can go on to win FDA approval, it is going to possible be a top-selling drug. Evofem expects to submit the complete outcomes from the trial for presentation at an upcoming scientific assembly. The info may also be used to request an end-of-phase 2 assembly with the FDA.



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