Agile Therapeutics Reports Additional Phase 3 SECURE Study Results Relating to Twirla® at ACOG 2017
07 5월 2017 - 3:05AM
Agile Therapeutics, Inc., (NASDAQ:AGRX), a women’s healthcare
company, today announced the presentation of additional results of
its Phase 3 SECURE trial of its investigational low-dose
combination hormone contraceptive patch, Twirla® (AG200-15). Anita
Nelson, MD, Professor and Chair of Obstetrics and Gynecology at the
College of Osteopathic Medicine of the Pacific, presented a summary
of SECURE clinical trial results, which included new data on the
bleeding profile of clinical trial subjects during a poster
presentation at the 2017 Annual Clinical and Scientific Meeting of
the American Congress of Obstetricians and Gynecologists (ACOG) in
San Diego, CA.
Dr. Nelson presented a summary of efficacy and
safety results from the company’s SECURE clinical trial, which were
previously reported in January 2017. The poster presentation also
reported analyses on the bleeding profile, which demonstrated that
unscheduled bleeding/spotting days per month decreased from a mean
of 3.1 days in Cycle 1 to 1.6 days in Cycle 13. In addition,
scheduled bleeding/spotting remained consistent during all cycles,
with a reported mean of 3.1 to 3.7 days per month. Dr. Nelson also
discussed the role of study designs and populations in
contraceptive clinical trials.
“The SECURE trial was unique for its broad
inclusion criteria and enrollment of diverse women with demographic
backgrounds reflective of real-world settings,” remarked Dr.
Nelson. “It is important to provide women with a variety of
contraceptive options and information so they can identify the
hormonal combination and delivery method best suited to their needs
and lifestyle.”
The Phase 3 SECURE study was a multicenter,
single-arm, open-label, 13 cycle trial designed to evaluate the
efficacy, safety and tolerability of AG200-15, also known as
Twirla, in 2032 healthy women, aged 18 years and over, at 102
investigational sites across the United States. The SECURE study
design included a number of stringent elements, including exclusion
of treatment cycles for use of back-up contraception and lack of
sexual activity. The SECURE clinical trial also had broad entry
criteria, placed no limitations on BMI or other demographic factors
during enrollment, and enrolled a large and diverse patient
population in order to allow efficacy to be assessed across
different, real-world groups, as requested by the FDA. These entry
criteria resulted in the inclusion of a substantial number of women
with a high BMI, who have frequently been underrepresented in past
contraceptive studies.
Elizabeth Garner, MD, MPH, Chief Medical Officer
of Agile Therapeutics, commented, “We are pleased with the results
of the SECURE trial and believe our study may set a new standard
for hormonal contraceptive studies. Our study entry criteria
resulted in the inclusion of a real-world study population,
including women who have frequently been underrepresented in past
contraceptive studies. We believe the SECURE trial has generated
valuable new data that will contribute to the evolving
understanding of how co-morbidities such as obesity and other
factors impact hormonal contraceptive effectiveness.”
For more information, please visit the company
website at www.agiletherapeutics.com.
About Agile Therapeutics,
Inc.Agile Therapeutics is a forward-thinking women's
healthcare company dedicated to fulfilling the unmet health needs
of today’s women. Our product candidates are designed to provide
women with contraceptive options that offer freedom from taking a
daily pill, without committing to a longer-acting method. Our lead
product candidate, Twirla®, (ethinyl estradiol and levonorgestrel
transdermal system), also known as AG200-15, is a once-weekly
prescription contraceptive patch that recently completed Phase 3
trials. 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 adhesion and patient wearability. 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 regulatory submissions. 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 beliefs and expectations of our management team
that involves 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. Our statements about the results and conduct of our
clinical trial could be affected by the potential that there are
changes in the data or interpretation of the data by the FDA (for
example, the FDA may include additional pregnancies in its
calculation of the Pearl Index, which would increase the Pearl
Index), whether the results will be deemed satisfactory by the FDA
(for example, we may describe the results of the SECURE trial as
positive, the FDA may disagree with that characterization), and
whether additional studies will be required or other issues will
arise that will delay resubmission of our NDA or negatively impact
acceptance, review and approval of Twirla by the FDA; 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; our statements about the planned
resubmission of our NDA for Twirla could be affected by the
potential that additional analyses of issues identified in our
complete response letter from the FDA are required to be completed
that were not previously anticipated, that our ongoing tests to
support our resubmission are not completed on time, that the third
parties we rely on to perform services in support of our NDA
resubmission do not complete their work in a timely fashion and
that other issues will arise that will delay resubmission of our
NDA or negatively impact acceptance, review, and approval of Twirla
by the FDA. 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.
Investor Relations Contact:
Mary Coleman
Agile Therapeutics
609-356-1921
Media Relations Contact:
Glenn Silver
Lazar Partners Ltd.
646-871-8485
gsilver@lazarpartners.com
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