Agile Therapeutics Announces Completion of Patient Enrollment in Twirla(R) Phase 3 SECURE Clinical Trial
20 10월 2015 - 5:09AM
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 it has reached full enrollment in its ongoing Phase
3 SECURE clinical trial of Twirla® (AG200-15), its investigational
combined hormonal contraceptive patch. The Company expects to
complete the trial of over 2,000 subjects in the second half of
2016.
“Reaching full enrollment in the SECURE clinical
trial is a major accomplishment for Agile and all those who have
been involved in our Twirla program. Our clinical sites
demonstrated their commitment to quality throughout this important
process of subject selection,” stated Elizabeth Garner, M.D, M.P.H,
Chief Medical Officer of Agile. “The patient demographics are
consistent with our goals of a broadly representative patient
population and fewer than twenty percent of subjects who are naïve
to hormonal contraceptive products. Together with our
partners and investigators, we now look forward to executing on
this final, 12-month phase of the trial with continued focus on
trial conduct and rigorous oversight, utilizing our technology
platforms to support subject compliance and retention while
minimizing loss to follow-up, all aimed at providing a high quality
data package at the end of the trial.”
The SECURE trial is a multicenter, single-arm,
open-label Phase 3 clinical trial in which healthy women 18 and
over will receive treatment with the investigational patch for up
to one year. The clinical trial will assess the effectiveness of
the patch in preventing pregnancy using the Pearl Index as the
primary contraceptive efficacy measure. Safety and tolerability
will also be evaluated. Twirla contains the active ingredients
ethinyl estradiol and levonorgestrel, both of which have an
established history of efficacy and safety in currently marketed
low-dose combination oral contraceptives. The patch is applied once
weekly for three weeks followed by a patch-free week, and is
designed to promote user compliance.
“We are very pleased with having achieved this
critical milestone for the Twirla development program. We
look forward to the results from the trial and we plan to submit
our response to FDA’s complete response letter in the first half of
2017,” said Al Altomari, President and Chief Executive Officer of
Agile. “Twirla represents an important new contraceptive
innovation for women and the potential to be the first low-dose
combined hormonal contraceptive patch.”
Additional information on the SECURE clinical
trial is available at www.clinicaltrials.gov.
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 Statement
Certain information contained in this press
release includes "forward-looking statements" related to the
Company's, projected timeline for 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 trial could
be affected by the potential that we experience difficulty in
enrolling subjects, 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.
Contact: Mary Coleman -- 609-356-1921
Agile Therapeutics (NASDAQ:AGRX)
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