Lipocine Announces Positive Top-Line Phase 2b Study Results for LPCN 1111, a Next Generation Oral Testosterone Replacement Th...
September 26 2016 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today reported positive top-line results from a Phase 2b clinical
study of LPCN 1111, a novel oral testosterone replacement therapy
("TRT") product candidate. The primary objectives of the study were
to determine the Phase 3 dose of LPCN 1111 along with the safety
and tolerability of LPCN 1111 and its metabolites following oral
administration of single and multiple doses in hypogonadal males.
The Phase 2b clinical trial was a randomized, open
label, two-period, multi-dose PK study that enrolled hypogonadal
males into five treatment groups. Each of the 12 subjects in a
group received treatment for 14 days. Results of the Phase 2b
study suggest that the primary objectives were met, including
identifying the dose expected to be tested in a Phase 3 study. Good
dose-response relationship was observed over the tested dose range
in the Phase 2b study. The target Phase 3 dose met primary
and secondary end points. LPCN 1111 was well tolerated with
no drug-related severe or serious adverse events reported.
“We are pleased to report these positive top-line results, as
these results reinforce our belief that LPCN 1111 represents a
promising product candidate for once daily administration of
testosterone," said Dr. Mahesh Patel, President and CEO of Lipocine
Inc. "Based on this progress, we plan to meet with the United
States Food and Drug Administration to discuss Phase 3 development
plans."
About LPCN 1111
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. LPCN
1111 comprises a novel prodrug different from the testosterone
ester in LPCN 1021 and it uses Lipocine’s proprietary
solubilization technology to improve systemic absorption to give
effective testosterone levels.
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 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 relating to the potential uses and benefits of
LPCN 1111 and the potential uses and benefits of our other product
candidates. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without
limitation, the risks related to our products, expected product
benefits, clinical and regulatory expectations and plans,
regulatory developments and requirements, the receipt of
regulatory approvals, the results 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:
John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com
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