BUSINESS
Overview
We are a
clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in womens sexual and reproductive health. We leverage our proprietary Multi-purpose Prevention Technology, or MPT,
vaginal gel to develop product candidates for multiple indications, including contraception, sexually transmitted infections, or STIs, and recurrent bacterial vaginosis, or BV.
Our MPT vaginal gel technology is an acid-buffering vaginal gel with bioadhesive properties, designed to maintain an optimal vaginal pH of 3.5 to 4.5. This vaginal pH range is inhospitable to spermatozoa,
or sperm, as well as certain viral and bacterial pathogens associated with STIs, and it is integral to the survival of healthy bacteria in the vagina.
We are developing our lead product candidate, Amphora (L-lactic acid, citric acid, and potassium bitartrate), for three potential indications: contraception, the prevention of urogenital
Chlamydia
trachomatis
infection, or chlamydia, in women and the prevention of urogenital
Neisseria gonorrhoeae
infection, or gonorrhea, in women.
In 2014, we completed a randomized, Phase 3 non-inferiority trial for Amphora as a contraceptive in 3,389 women. Amphora was shown to be non-inferior to control, with a six-month cumulative pregnancy rate
of 10.5% with typical use and 4.1% with perfect use. It was also well-tolerated with less than 2% of patients experiencing possible treatment-related adverse events, or AEs, and no treatment-related serious adverse events, or SAEs.
We are conducting a confirmatory, open-label, single-arm Phase 3 trial for Amphora as a contraceptive in 1,400 women in the United States.
We expect to report top-line results from this trial in the first quarter of 2019 and, if positive, to resubmit the New Drug Application, or NDA, to the United States Food and Drug Administration, or the FDA, shortly thereafter. Subject to
acceptance and timely approval of the NDA by the FDA, we plan to commercialize Amphora in early 2020.
We believe Amphora is
highly differentiated from other forms of contraceptives currently available or in development. Amphora is hormone-free and, based on our clinical data collected to date, does not exhibit known side effects of traditional hormonal-based
contraceptives, such as weight gain, headaches, sore breasts, irregular periods, mood changes, decreased sexual desire and nausea. Amphora is self-administered and we intend to seek regulatory approval for product labeling stating Amphora can be
used on-demand, immediately before or up to one hour before intercourse. In addition, we anticipate Amphora may provide additional benefits beyond its primary use as a contraceptive, including its lubricant effect for enhanced sexual satisfaction.
We are also conducting a Phase 2b/3 clinical trial of Amphora for the prevention of certain STIs. The primary endpoint of this
trial is prevention of chlamydia in women; the secondary endpoint is prevention of gonorrhea in women. We envision our STI program as developing label expansion opportunities to further differentiate Amphora from other contraceptive products in the
market.
Preclinical studies conducted by Rush University Medical Center, or Rush University, suggest Amphora may suppress many
of the pathogens responsible for sexually transmitted and commonly occurring bacterial infections while leaving the beneficial bacteria unaffected. Amphora has been granted Qualified Infectious Disease Product, or QIDP, designation by the FDA for
the prevention of gonorrhea in women, and has been granted QIDP designation by the FDA for the prevention of the recurrence of BV. QIDP designation provides several key potential advantages, including qualification for the FDA Fast Track
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