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Evofem Biosciences (OTCQB:EVFM) stated a part 3 trial of EVO100 (vaginal gel Phexxi) to stop chlamydia and gonorrhea an infection in ladies didn’t obtain its objectives and that the corporate is not going to make investments additional within the growth of STI scientific program on account of monetary assets.
The examine known as EVOGUARD enrolled 1903 ladies and evaluated Phexxi vaginal gel for stopping urogenital Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) an infection versus placebo.
Phexxi (lactic acid, citric acid and potassium bitartrate) is a hormone free contraception vaginal gel authorized within the U.S. to stop being pregnant.
The primary objective was proportion of individuals, among the many modified Intent to Deal with (mITT) inhabitants, who had been destructive for CT and GC at enrollment and had been supplied with examine product who efficiently accomplished the 16 weeks with none chlamydia or gonorrhea an infection.
Evofem CEO Saundra Pelletier stated that the corporate believes that adjustments in scientific website operations, affected person habits, deviations from examine protocol necessities associated to STI acquisition, detection, and prevention contributed to this consequence.
“As scientific examine lead for the Section 2b/3 AMPREVENCE STI trial and the Section 3 EVOGUARD trial, I imagine the examine surroundings modified considerably from the AMPREVENCE trial to the EVOGUARD trial, particularly topic danger behaviors in addition to website and CRO turnover. In a non-COVID surroundings, I imagine the outcomes would have doubtless been completely different, and that an infection charges would have been increased within the placebo arm, as was seen in AMPREVENCE,” stated Brandi Howard in an Oct. 12 press launch.
Evofem famous that the product security profile was in step with what was seen in prior trials, and solely two ladies (0.1%) within the examine discontinued on account of antagonistic occasions.
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