SALT LAKE CITY, Dec. 31, 2018 /PRNewswire/ -- Lipocine,
Inc. (NASDAQ: LPCN), a specialty pharmaceutical company,
today announced completion of a definitive phlebotomy study
("Phlebotomy Study") to assess the extent, if any, of clinically
meaningful ex vivo conversion of testosterone undecanoate
("TU") to testosterone ("T") in serum blood collection tubes.
TLANDO is the Company's 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 Phlebotomy Study was designed based on the U.S. Food and
Drug Administration's ("FDA") protocol recommendations and
conducted in response to a deficiency cited in the TLANDO Complete
Response Letter ("CRL") by the FDA to confirm the reliability of
TLANDO Phase 3 study results.
The Phlebotomy Study measured T concentrations in blood samples
collected in plain serum separation tubes ("SST") at three-hour and
five-hour time points (N=24) post dose and processed within 30
minutes of sample collection under the tube manufacturer's
recommended conditions and consistent with Phase 3
instructions. The Phlebotomy Study enrolled 12 hypogonadal
male subjects and dosed subjects with a single oral 225 mg TU dose
of TLANDO. The T measurements in SST were compared against the
FDA's recommended time zero control (processed immediately)
measurement of T concentrations in blood samples in plasma tubes
with EDTA ("PT") to assess ex vivo conversion, if
any.
The topline results of the study demonstrated that the overall
(N=24) mean percentage difference and the associated percentage
standard deviation post dose of T concentrations measured between
SST samples and PT samples are -1.0% and 9.2%,
respectively. This difference was not statistically
significant (p = 0.91) which suggests no significant ex
vivo TU to T conversion occurrence with T measurements done
consistent with the provided Phase 3 study instructions for blood
collection and sample processing.
"We are pleased with the Phlebotomy Study results which supports
the reliability of TLANDO T clinical measurements. We believe
these results address one of the FDA's identified deficiencies and
a successful step towards the resubmission of the TLANDO NDA," said
Dr. Mahesh Patel, Chairman,
President and CEO of Lipocine Inc. "We remain committed to bring
TLANDO to patients in a timely manner as it represents a growing
unmet need," Dr. Patel added.
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 four development programs TLANDO, LPCN 1144, LPCN
1111 and LPCN 1107. TLANDO, a novel oral prodrug of testosterone
containing testosterone undecanoate, is designed to help restore
normal testosterone levels in hypogonadal men. TLANDO received a
Complete Response Letter from the FDA on May
8, 2018. LPCN 1144, an oral prodrug of bioidentical
testosterone, is being developed as a treatment of non-alcoholic
steatohepatitis ("NASH") and is currently being studied in a
proof-of-concept MRI PDFF based liver fat imaging clinical study.
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
Phase 2 testing. LPCN 1107 is potentially the first oral
hydroxyprogesterone caproate product candidate indicated for the
prevention of recurrent preterm birth and 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 product candidates and related clinical trials
and the FDA review process relating to its product candidates, the
timing of completion of clinical trials including the definitive
phlebotomy study and the ABPM study for TLANDO as well as ongoing
LPCN 1144 clinical trials, the path to approvability by the FDA of
Lipocine's development programs, 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 any of our products, risks
related to our products, expected product benefits not being
realized, clinical and regulatory expectations and plans not being
realized, new regulatory developments and requirements, risks
related to the FDA approval process including 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.
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SOURCE Lipocine Inc.