On 2 December Evofem Biosciences announced positive top-line results from the Phase IIb AMPREVENCE trial evaluating the efficacy and safety of its lead candidate Amphora for the prevention of urogenital chlamydia and gonorrhoea in women.
The study met both its primary and secondary endpoints of reducing the risk of chlamydia and gonorrhoea infection, respectively, with the company’s stock price rising more than 25% upon the announcement.
Amphora, a multipurpose vaginal gel pH regulator, is also being developed as a female contraceptive. GlobalData believes that the favourable data demonstrated in the AMPREVENCE trial will drive broader use of Amphora and provide a new market opportunity for the product with the added benefit of preventing sexually transmitted infections (STIs).
Key opinion leaders (KOLs) interviewed by GlobalData viewed Amphora’s efficacy as a contraceptive questionable when used as the sole method but further opined that Amphora’s potential role in protecting women from the infection will make it an attractive product for women at risk of contracting STIs.
Amphora can be an appealing option for women seeking a non-hormonal contraceptive, who are willing to accept a higher chance of unintended pregnancy compared to the hormonal options while benefiting from increased protection against STIs, especially when healthcare access may be limited.
Amphora has the advantage of fewer side effects compared to hormonal contraceptives. However, it also demonstrates lower efficacy than hormonal contraception (89.5% and 95.9% contraceptive efficacy with typical and perfect use, respectively). Although there is an unmet need for non-hormonal contraceptives for women of reproductive age, Amphora may only partially fulfil this need because of its low efficacy profile and the expected need for an additional barrier.
Non-hormonal contraceptives offer another option for women who want to avoid the side effects of hormonal contraceptives. Following a complete response letter (CRL) from the Food and Drug Administration (FDA) in 2016, Evofem resubmitted a New Drug Application (NDA) last month, based on positive data from AMPOWER and prior results from the earlier AMP001 trial, seeking approval for the prevention of pregnancy.