Agile Therapeutics, Inc. Presents Additional Analyses of AG200-15 (Twirla®) Phase 3 SECURE Study Results at the 2018 North A...
October 24 2018 - 8:00AM
Agile Therapeutics, Inc., (Nasdaq: AGRX), a women’s healthcare
company, today announced an oral presentation regarding predictors
of pregnancy in the Phase 3 SECURE study of the investigational
low-dose, once-weekly contraceptive patch, AG200-15 (Twirla®).
Thomas D. Kimble, MD, Associate Dean and Assistant Professor of
Obstetrics and Gynecology at Eastern Virginia Medical School,
presented the new analyses at the North American Forum on Family
Planning (NAFFP), “The Forum”, on October 20, 2018 in New Orleans,
LA.
The presentation, entitled Body Mass Index and
Weight are Predictors of Pregnancy in a Phase 3 Multicenter
Contraceptive Efficacy Study of AG200-15, a Low-Dose Combination
Hormonal Contraceptive Patch, included detailed findings of
statistical modeling performed to identify variables predictive of
pregnancy in the SECURE study. The abstract is published in the
October 2018 issue of Contraception.
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
included a number of stringent design elements, including exclusion
of treatment cycles for use of back-up contraception and for lack
of sexual activity. The study 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.
About Twirla® (AG200-15)
Twirla (levonorgestrel/ethinyl estradiol
transdermal system) or AG200-15 is an investigational low-dose,
once-weekly contraceptive patch. AG200-15 is a combined hormonal
contraceptive (CHC) patch that contains the active ingredients
ethinyl estradiol (EE), a type of estrogen and levonorgestrel
(LNG), a type of progestin. Twirla is designed to be applied once
weekly for three weeks, followed by a week without a patch.
Agile received a complete response letter (CRL) from the FDA on
December 21, 2017 relating to the New Drug Application (NDA) for
Twirla. In the CRL, the FDA informed the Company that the
product could not be approved in its present form due to
deficiencies related to quality adhesion test methods, observations
identified during the pre-approval inspection of the manufacturing
facility for Twirla, and because of questions the FDA had on the in
vivo adhesion properties of Twirla and their potential relationship
to the Company’s Phase 3 clinical trial results. The FDA
provided a path forward for resubmitting the Twirla NDA and
suggested the Company conduct a comparative wear study to evaluate
whether Twirla demonstrates generally similar adhesion performance
to Xulane®. The Company plans to meet with the FDA to
gain agreement on the specific design and success criteria for a
wear study as soon as possible. The Company believes the FDA
provided guidance on a path forward for addressing the
manufacturing issues related to Twirla in its minutes from the End
of Review Type A meeting, received by the Company in May 2018.
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® (levonorgestrel/ethinyl estradiol
transdermal system) or AG200-15, is an investigational low-dose,
non-daily, prescription contraceptive. Twirla is based on our
proprietary transdermal patch technology, called Skinfusion®, which
is designed to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may occasionally disseminate
material, nonpublic information on the Company’s website.
Follow Agile on LinkedIn and Twitter:
@AgileTher.
Xulane® is a registered trademark of Mylan N.V.
Forward-Looking Statements
Certain information contained in this press release
includes "forward-looking statements", within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, related to
our regulatory submissions for Twirla. We may, in some cases use
terms such as "believes," "potential," "continue,"
"plans," "may," “might," 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 involve risks,
potential changes in circumstances, assumptions, and uncertainties,
including statements regarding our intention to meet with the FDA,
the timing of which is subject to FDA’s discretion and which may
not result in a clear agreement on the issues discussed, and our
belief that a reformulation of Twirla may not be necessary.
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. These forward looking
statements are subject to risks and uncertainties including risks
related to the FDA requiring us to reformulate Twirla, our ability
to develop a reformulation that will address the FDA’s concerns,
including showing bioequivalence, if necessary, our ability to
successfully complete the suggested wear study and that the results
do not support a conclusion by the FDA that Twirla has demonstrated
adequate adhesion, and, the potential that we may be required to
conduct an additional Phase 3 trial, the likelihood that we will
require additional correspondence with the FDA prior to the
resubmission of our NDA, in addition to the planned correspondence
regarding the design of the suggested wear study, our ability to
resubmit and the timing of our resubmission of the NDA for Twirla,
FDA acceptance and approval of the resubmitted NDA, or whether
other issues will arise that will negatively impact acceptance,
review, and approval of Twirla by the FDA, including a
determination by the Advisory Committee that Twirla should not be
approved, our ability to address the deficiencies identified by the
FDA in the CRL issued in December 2017 and in the Type A meeting
minutes issued in May 2018, the fact that our existing cash and
cash equivalents may not be sufficient to fund the completion of
the development and regulatory review process for Twirla, our
ability to raise capital when needed to complete the development
and regulatory review process for Twirla, and unforeseen market
factors or events in our clinical and manufacturing development
plans and the other risks set forth in our filings with the U.S.
Securities and Exchange Commission, including our Annual Report on
Form 10-K and our Quarterly Reports on Form 10-Q. For all
these reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. 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.
SOURCE: Agile Therapeutics, Inc.
Contact:
Investor Relations
Agile Therapeutics
609-683-1880
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