CHICAGO, IL--(Marketwire - May 06, 2009) - Agile Therapeutics, Inc., presented new detailed data on ethinyl estradiol (EE) and levonorgestel (LNG) hormone levels, safety and ovulation suppression on its lead product, AG200-15, an innovative low-dose weekly contraceptive patch now entering Phase 3 clinical trials to show efficacy, safety and tolerability. Agile’s proprietary SKINFUSIONTM technology makes it possible to use the trusted hormone combination of ethinyl estradiol and levonorgestrel in a weekly, low-dose patch that is comfortable to wear.
Presented at two poster sessions at the American College of Obstetricians and Gynecologists (ACOG) 57th Annual clinical Meeting, in Chicago, IL, Agile reported that the EE and LNG levels for AG200-15 were consistent over three cycles and within range of low-dose oral contraceptives. In the pharmacokinetic study, EE levels were significantly lower when compared to Levlen, a 30 mcg combination oral contraceptive. AG200-15 will be the first contraceptive patch to offer women a low-dose option consistent with market trends for oral contraceptives.
Data on ovarian suppression indicated that AG200-15’s efficacy will be comparable to popular, currently marketed oral contraceptives. The bleeding profile and other hormone related adverse events were similar to published data for low-dose oral contraceptives. Patients reported excellent adhesion and skin tolerability.
According to market research conducted on behalf of Agile with 105 OB/GYN physicians who are significant prescribers of contraception, 89 percent said they would be likely to prescribe AG200-15. If it were available today, almost half said they would prescribe it immediately, showing that physicians recognize a large need with their patients for the comfort and convenience of Agile’s low-dose, weekly contraceptive patch. This physician data supports earlier Agile market research with 1,500 women, of whom almost two-thirds who desired contraception said they would ask their doctor about AG200-15 if it were available to them.
Daniel R. Mishell, M.D., Professor in the Department of Obstetrics and Gynecology at the University of Southern California, and a member of Agile’s Scientific Advisory Board, commented, “In these Phase 2 studies, AG200-15 demonstrated that it delivered a consistent EE level comparable to low-dose oral contraceptives. AG200-15’s weekly, low-dose, efficacy and side effect profile will fill a major unmet need for a convenient, safe and efficacious contraceptive.”
Marie Foegh, M.D., Chief Medical Officer and Vice President, Clinical Research and Development of Agile, said, “We are happy to share important additional data on our clinical program for Agile’s weekly, low-dose contraceptive patch during this very important scientific meeting. Based on the ovulation suppression data, bleeding and hormone related adverse event profile, we selected AG200-15 as the lead contraceptive patch candidate for Phase 3 development.”
Pharmacokinetic Study (Monday, Poster #28)
The pharmacokinetic study was an open-label, randomized, comparative, single-center, two-period cross-over study with 39 patients that evaluated two contraceptive patches to see if the systemic exposure of ethinyl estradiol (EE) and levonorgestrel (LNG) were comparable to the low-dose oral contraceptive, Levlen. As intended, both the EE and LNG exposure of both patches were less than Levlen and consistent with the levels targeted by the company.
Phase 2b Study (Tuesday, Poster #27)
In this multi-centered, multi-cycle Phase 2b safety and efficacy study of 123 women, the Company studied patches with different estrogen and progestin doses for three cycles to identify the regimen providing the best efficacy (as demonstrated by ovulation suppression), cycle control and tolerability at the lowest hormonal dose. Top-line results from the trial showed there was a clear dose-response to ovulation suppression and cycle control. AG200-15 provided the greatest ovulation suppression with the best cycle control of the three regimens studied.
About AG200-15, Agile’s Low-Dose Contraceptive Patch
AG200-15 with SKINFUSION™ technology is a low-dose, weekly contraceptive patch that is entering Phase 3 development with a clearly defined regulatory pathway. SKINFUSION™ technology makes it possible to utilize the trusted hormone combination of levonorgestrel and ethinyl estradiol in a contraceptive patch. AG200-15 has completed Phase 2 development and met all target endpoints, including providing estrogen dose, ovulation suppression, and side-effect similar to low-dose oral contraceptives. The patch was designed for flexibility and comfort.
About Estrogen
Estrogen is associated with certain common side effects, such as breast tenderness, bloating/weight gain and nausea. These side effects are believed to be related to the level of estrogen exposure. In some rare cases, high estrogen levels are thought to be linked with serious, cardiovascular side effects in some women. Therefore, low doses of estrogen in hormonal contraception are desired.
About Agile Therapeutics, Inc.
Agile Therapeutics is a high-growth, late-stage pharmaceutical company specializing in women’s health products prescribed by OB/GYNs with an initial focus on developing safer, more convenient methods of hormonal contraception. Agile’s lead product is AG200-15, an innovative, weekly, low-dose combination contraceptive patch, has the potential to become a major product in the $5 billion global hormonal contraceptive market (U.S. market $3 billion). AG200-15 is also based on Agile’s patented SKINFUSION™ technology, and utilizes the trusted hormonal combination of levonorgestrel and ethinyl estradiol. The lead product is moving into Phase 3 clinical development. Agile is privately financed, with a solid foundation for growth and backed by experienced healthcare investors, including ProQuest Investments, The Hillman Company, TL Ventures, and Novitas Capital. For more information, please visit http://www.agiletherapeutics.com.
