Lipocine Initiates a Dosing Flexibility Study for LPCN 1021, Its Oral Testosterone Replacement Product Candidate
January 05 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced plans to initiate a dosing flexibility (“DF”) study
in addition to its previously announced dosing validation (“DV”)
study for LPCN 1021. LPCN 1021 is an oral testosterone
product candidate for testosterone replacement therapy ("TRT") in
adult males for conditions associated with a deficiency of
endogenous testosterone, also known as hypogonadism. The DF
study will assess LPCN 1021 in hypogonadal males on a fixed daily
dose of 450 mg divided into three equal doses whereas the DV study
is assessing the impact of LPCN 1021 in hypogonadal males on a
fixed daily dose of 450 mg divided into two equal doses. Lipocine
expects resubmission of the LPCN 1021 new drug application (“NDA”)
to the U.S. Food and Drug Administration ("FDA") to contain data
from both the DV study and the DF study.
Lipocine expects the first patient of the DF study to be
enrolled in the first quarter of 2017 with top-line results
projected in the second quarter of 2017. The DF study is an
open-label, fixed dose, single treatment arm study of LPCN 1021 and
is expected to enroll 100 hypogonadal males. 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”).
"We are pleased to initiate the DF study with LPCN 1021 as we
continue to advance LPCN 1021 into a position for approval,” said
Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. “We
remain on track with our DV study and continue to expect top-line
results from the DV study in the second quarter of 2017.”
About LPCN 1021
LPCN 1021 is a novel 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 September 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 was well
tolerated and met the primary efficacy end-point in Phase 3
testing, which utilized 24-hour pharmacokinetic data for dose
adjustments. LPCN 1111, a novel prodrug of testosterone,
originated with and is being developed by Lipocine as a
next-generation oral testosterone product with potential for
once-daily dosing and is currently in Phase 2 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 was recently 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 dosing validation and dosing
flexibility studies, Lipocine’s FDA review process relating to LPCN
1021, the possible outcome and timing of such clinical trial or FDA
review process, the path to approvability by the FDA of LPCN 1021,
our commitment to bring LPCN 1021 to market, the potential
uses and benefits of our product candidates, and our product
development efforts. 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, clinical and regulatory
expectations and plans, regulatory developments and requirements,
risks related to the receipt of a CRL from the FDA for LPCN 1021,
risks related to the receipt of regulatory approvals, the results
and timing of clinical trials, including the additional clinical
trials for LPCN 1021, 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:
John Woolford
Phone: (443) 213-0506
john.woolford@westwicke.com
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