Lipocine to Initiate Dosing Validation Study for LPCN 1021, Oral Testosterone Replacement Product Candidate
December 05 2016 - 08:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced it plans to initiate a dosing validation study
after receiving feedback from the U.S. Food and Drug Administration
(“FDA”) of its protocol 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.
Based on the assessment received, Lipocine plans to initiate the
dosing validation (“DV”) study immediately and expects that the
first patient will be screened in December 2016. The results
of the DV study are expected to validate the dosing regimen for
LPCN 1021 and provide critical data required for
resubmission. The DV study is an open-label, fixed dose,
single treatment arm study of LPCN 1021 in hypogonadal males and is
expected to enroll 100 subjects. 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 with the clarity received from the FDA on the DV
study protocol, especially as we continue to advance LPCN 1021 into
a position for approval,” said Dr. Mahesh Patel, Chairman,
President and CEO of Lipocine. “We look forward to the DV study
initiation with top-line results from the DV study anticipated in
the second quarter of 2017."
About LPCN 1021
LPCN 1021 is a novel twice-a-day 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 so far in 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 twice-daily oral
testosterone replacement therapy product candidate, 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 FDA review process relating
to LPCN 1021, the additional clinical trial needed to validate our
dosing regimen and the FDA process with respect to our planned SPA,
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 results of the
Phase 2b clinical study of LPCN 1111, 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, the receipt of
regulatory approvals, the results and timing of clinical trials,
including the additional clinical trial 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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