Lipocine Completes Enrollment in the LPCN 1021 Fixed Dose Clinical Trials
April 24 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced the completion of enrollment for both its dosing
validation ("DV") study and its dosing flexibility ("DF") study for
LPCN 1021. LPCN 1021 is an oral testosterone product
candidate for testosterone replacement therapy in adult males for
conditions associated with a deficiency of endogenous testosterone,
also known as hypogonadism.
"We are pleased to complete enrollment for the DV and DF studies
which do not require any dose titration; thereby addressing the
cited deficiency in the U.S. Food and Drug Administration’s (“FDA”)
Complete Response Letter,” said Dr. Mahesh Patel, Chairman,
President and CEO of Lipocine. “We look forward to announcing the
top-line results from these studies in June 2017, an important
milestone toward the resubmission of LPCN 1021.”
The DV study will assess LPCN 1021 in hypogonadal males on a
fixed daily dose of 450 mg divided into two equal doses. The DV
study is an open-label, fixed dose, no titration single treatment
arm study of LPCN 1021. Efficacy will be assessed via
responder analysis at the end of the dosing period which is 24
days. The pre-specified primary endpoint is the percentage of
subjects with an average 24-hour serum testosterone concentration
("Cavg") within the normal range, with secondary endpoints based on
maximum serum testosterone concentrations ("Cmax").
The DF study will assess LPCN 1021 in hypogonadal males on a
fixed daily dose of 450 mg divided into three equal doses. The DF
study is an open-label, fixed dose, no titration, single treatment
arm study of LPCN 1021. Efficacy will be assessed via
responder analysis at the end of the dosing period which is 24
days. The pre-specified primary endpoint is Cavg within the
normal range, with secondary endpoints based on Cmax.
About LPCN 1021
LPCN 1021 is an oral testosterone replacement therapy product
candidate containing Testosterone Undecanoate that is designed to
help restore normal testosterone levels in hypogonadal men.
Lipocine expects LPCN 1021 will help fulfill an unmet need in the
treatment of hypogonadism. The current testosterone market
primarily uses short-acting injectable products as well as topical
products that carry an FDA "black box" warning related to
inadvertent transfer of testosterone to others. Per the IMS Health
database, an average of 540,000 prescriptions a month have been
dispensed from January 2016 through December 2016 for testosterone
products.
About Lipocine
Lipocine Inc. is a specialty pharmaceutical company developing
innovative pharmaceutical products for use in men's and women's
health using its proprietary drug delivery technologies. Lipocine’s
clinical development pipeline includes three development programs
LPCN 1021, LPCN 1111 and LPCN 1107. LPCN 1021, a novel oral
prodrug of testosterone containing Testosterone Undecanoate, is
designed to help restore normal testosterone levels in hypogonadal
men. LPCN 1021, was well tolerated and met the primary efficacy
end-point in Phase 3 testing, which utilized 24-hour
pharmacokinetic data for dose adjustments, and is currently being
studied in two additional Phase 3 clinical trials. LPCN 1111,
a novel oral prodrug of testosterone, originated and is being
developed by Lipocine as a next-generation oral testosterone
product with potential for once-daily dosing and is currently in
pre-Phase 3 testing. LPCN 1107, the potentially first oral
hydroxyprogesterone caproate product candidate indicated for the
prevention of recurrent preterm birth, has been granted orphan drug
designation by the FDA. An End of Phase 2 meeting with the FDA has
been completed. For more information, please visit
www.lipocine.com.
Forward-Looking Statements
This release contains “forward-looking statements” that are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995 and include statements that are not
historical facts regarding Lipocine’s FDA review process relating
to LPCN 1021, the DV and DF studies, the possible outcome and
timing of the DV and DF studies, the path to approvability by the
FDA of LPCN 1021 and other development programs for LPCN 1111 and
LPCN 1107. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without
limitation, the risks that the FDA will not approve LPCN 1021 or
any of our other products, risks related to our products, expected
product benefits not being realized, clinical and regulatory
expectations and plans, regulatory developments and requirements,
risks related to the FDA approval process, the receipt of
regulatory approvals, the results and timing of clinical trials,
patient acceptance of Lipocine’s products, the manufacturing and
commercialization of Lipocine’s products, and other risks detailed
in Lipocine’s filings with the SEC, including, without limitation,
its Form 10-K and other reports on Forms 8-K and 10-Q, all of which
can be obtained on the SEC website at www.sec.gov. Lipocine assumes
no obligation to update or revise publicly any forward-looking
statements contained in this release, except as required by
law.
CONTACT:
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
mb@lipocine.com
Investors:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
Lipocine (NASDAQ:LPCN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Lipocine (NASDAQ:LPCN)
Historical Stock Chart
From Apr 2023 to Apr 2024