Agile Therapeutics Announces Plans to Advance Contraceptive Pipeline
13 7월 2016 - 5:12AM
Agile Therapeutics, Inc. (Nasdaq:AGRX), a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products, today
announced that preparations are underway for an initial Phase 2
clinical trial of a novel contraceptive regimen, which will begin
the development of its pipeline beyond its current lead product
candidate, Twirla®, a once weekly contraceptive patch currently in
phase 3 development. The planned Phase 2 clinical trial will
examine the use of Twirla in an innovative regimen designed to
allow women to experience shorter, lighter periods.
“Today marks an important step for Agile as we
begin to execute our strategic plan to develop our pipeline of new
product candidates based on Twirla,” said Elizabeth Garner, M.D.,
M.P.H., Chief Medical Officer of Agile. “Agile’s pipeline is
designed to build on our current patch regimen and offer women
additional, convenient non-daily contraceptive options that provide
flexibility to meet their needs.”
Agile plans to conduct an initial phase 2 study of
a novel 28-day contraceptive patch regimen (AG200-SP) designed to
optimize the bleeding profile by delivering hormones beyond the
typical 21 day regimen using a smaller lower dose combination
ethinyl estradiol/levonorgestrel patch (SmP) in the fourth week of
the cycle. The SmP regimen is intended to allow women to experience
shorter, lighter periods, an attribute that research suggests is
highly desirable to women seeking hormonal contraception. The
planned study is aimed at identifying the optimal dose of the SmP,
and will evaluate bleeding profiles, pharmacokinetic parameters,
ovulation inhibition and safety over 3 cycles of treatment.
Up to 150 subjects are expected to be enrolled at highly
experienced sites that are also participating in the ongoing Phase
3 SECURE clinical trial. The Company has started preparations
for the study and expects to initiate dosing in the first quarter
of 2017. Agile also plans to develop an extended cycle
regimen for Twirla (AG200-ER) that may also utilize the SmP with
the goal of allowing women to have fewer periods each year.
“Expanding our pipeline is a key element of our
strategic plan,” said Al Altomari, Chief Executive Officer and
President of Agile. “Based on patent protection expected to extend
into 2029, we believe we are in a strong position to build a
women’s health franchise that will enable us to be commercially
competitive and expand our market potential.”
About Agile Therapeutics,
Inc.Agile Therapeutics is a women's health specialty
pharmaceutical company focused on the development and
commercialization of new prescription contraceptive products. Our
product candidates are designed to provide women with contraceptive
options that offer greater convenience and facilitate compliance.
Our lead product candidate, Twirla®, (ethinyl estradiol and
levonorgestrel transdermal system), also known as AG200-15, is a
once-weekly prescription contraceptive patch currently in Phase 3
clinical development. Twirla is based on our proprietary
transdermal patch technology, called Skinfusion®, which is designed
to provide advantages over currently available patches and is
intended to optimize patch adherence and patient acceptability. For
more information, please visit the Company website at
www.agiletherapeutics.com. The Company may occasionally
disseminate material, nonpublic information on the Company
website.
Forward-Looking StatementCertain
information contained in this press release includes
"forward-looking statements" related to the Company's, product
candidate pipeline, timing and conduct of clinical trials and
potential market opportunity for its product candidates. We may, in
some cases use terms such as "predicts," "believes," "potential,"
"continue," "anticipates," "estimates," "expects," "plans,"
"intends," "may," "could," “might," "will," "should" or other words
that convey uncertainty of the future events or outcomes to
identify these forward-looking statements. Our forward-looking
statements are based on current expectations that involve risks,
potential changes in circumstances, assumptions and uncertainties.
Any or all of the forward-looking statements may turn out to be
wrong, or be affected by inaccurate assumptions we might make or by
known or unknown risks and uncertainties. For example, our
statements about the timing and conduct of our clinical trials and
our ability to potentially commercialize our product candidates,
could be affected by the potential that we experience slower than
expected enrollment, we identify serious side effects or other
safety issues, we do not have clinical supply of our product
candidate that is adequate in amount and quality and supplied in a
timely fashion, and the inherent risks of clinical development; our
statements about the potential commercial opportunity could be
affected by the potential that our product does not receive
regulatory approval, does not receive reimbursement by third party
payors, or a commercial market for the product does not develop
because of any of the risks inherent in the commercialization of
contraceptive products. For all these reasons, actual results and
developments could be materially different from those expressed in
or implied by our forward-looking statements. All forward looking
statements are subject to risks detailed in our filings with the
U.S. Securities and Exchange Commission, including the Company's
Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q.
You are cautioned not to place undue reliance on these
forward-looking statements, which are made only as of the date of
this press release. We undertake no obligation to publicly update
such forward-looking statements to reflect subsequent events or
circumstances.
Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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