Agile Therapeutics, Inc.,
announced that it successfully completed two key clinical trials in
the development of the company's new, innovative low-dose, once-weekly,
contraceptive patch, which the company refers to by its internal product
code AG-200-15. The Phase 2b safety and efficacy study successfully met its
primary endpoint of ovulation suppression, cycle control and safety. The
pharmacokinetic (PK) study demonstrated estrogen levels comparable with the
well-established, low-dose oral contraceptive, LEVLEN(R). There were no
serious adverse events in either study. With the successful pharmacokinetic
and Phase 2b safety and efficacy study results, the Company will discuss
its Phase 3 plans for AG-200-15 with the Food and Drug Administration
(FDA).
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, "Successful completion of the
Phase 2b safety and efficacy study is an important step forward in proving
the safety and efficacy of Agile's important, new low-dose contraceptive
patch. For years, OB/GYN's have been recommending low-dose oral
contraceptives to their patients considering hormone-based contraceptives.
If shown to be safe and effective, a low-dose, once-weekly contraceptive
patch would be a natural and needed addition to the hormonal-based
contraceptives and an alternative to once-daily oral contraceptives."
Thomas Rossi, Ph.D., Agile's President and Chief Executive Officer,
commented on the top-line data, "The purpose of conducting these studies
was to demonstrate that our product delivers an appropriate, low dose of
estrogen, and an effective dose of the progestin, levonorgestrel. We are
very pleased with the clinical outcomes, which, in addition to helping us
select the optimal dose for our Phase 3 program, also demonstrate that our
patch gives reliable adhesion and is well tolerated when worn for 7 days.
Based upon these results, we have been able to select AG-200-15 as our
candidate for Phase 3 development. We are looking forward to discussing our
results with the FDA and solidifying our Phase 3 plan."
Pharmacokinetic Study
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(R). As intended, both the EE and LNG exposure
over time of both patches were less than LEVLEN(R) and consistent with the
levels targeted by the company.
Phase 2b Study
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. AG-200-15 provided the greatest ovulation suppression with the
best cycle control of the three regimens studied.
About Agile's Product
Agile's low-dose contraceptive patch offers women a convenient, once-
weekly form of birth control. Many women prefer a weekly patch over having
to remember to take the pill daily. The Company's low-dose, patented,
round, soft, and flexible patch delivers 60 percent less estrogen than the
only marketed patch available today, Ortho EVRA(R). New market research
conducted by Agile in 2008 with approximately 1,000 women of reproductive
age highlight that more than 30 percent of women are not satisfied with
their current contraceptive methods. In addition, the vast majority of
these women found Agile's low-dose contraceptive patch appealing and over
50 percent would talk with their doctors about using it. Agile's low-dose
contraceptive patch is expected to fill a sizeable need in the $6 billion
global ($2.5 billion U.S.) hormonal contraceptive market.
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 hormones delivered into the blood
stream, particularly with higher levels of estrogen. 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.
According to FDA labeling, women using Ortho EVRA(R) are exposed to
about 60 percent more estrogen than if they were using typical birth
control pills. Increased levels of estrogen may increase the risk of blood
clots, which lead the FDA to add precautions to Ortho EVRA's label.
About Agile Therapeutics, Inc.
Agile Therapeutics is a privately held, specialty pharmaceutical
company focused on the development of innovative women's healthcare
products. Historically, the women's healthcare market offers unique
opportunities to a company with proven expertise in clinical development,
regulatory affairs, transdermal drug delivery and commercialization
experience.
Agile's current venture investors include TL Ventures, Novitas Capital
(formerly PA Early Stage Partners), ProQuest Investments, and The Hillman
Company. The Company has raised a total of $35 million in venture funding
to date. For more information, please visit
agiletherapeutics.
LEVLEN(R) is a registered trademark of Berlex Laboratories
Ortho EVRA(R) is a registered trademark of OrthoMcNeil(TM)
Agile Therapeutics, Inc.
agiletherapeutics
View drug information on Estradiol Transdermal System.