Lipocine Receives FDA Guidance on the Phase 3 Program for LPCN 1107, an Oral Alternative for the Prevention of Preterm Birth
January 09 2017 - 7:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced receipt of additional guidance from the U.S. Food
and Drug Administration (“FDA”) on the LPCN 1107 pivotal Phase 3
clinical study design. LPCN 1107, a novel oral
hydroxyprogesterone caproate (“HPC”) product candidate that has
been granted orphan drug designation by the FDA, is in development
for the proposed indication of reducing the risk of preterm birth
(“PTB”) in women with singleton pregnancy who have a history of
singleton spontaneous PTB. Prevention of PTB is a significant unmet
need as ~11.7% of all U.S. pregnancies result in PTB (delivery less
than 37 weeks), a leading cause of neonatal mortality and
morbidity.
The recent guidance received is in addition to feedback provided
at the End of Phase 2 meeting with the FDA which occurred in August
2016. During the End of Phase 2 meeting and subsequent guidance
meetings, the FDA agreed to a randomized, open-label, two-arm
clinical study to include a LPCN 1107 arm and a comparator IM arm
with treatment up to 23 weeks. The FDA also provided
feedback on other critical Phase 3 study design considerations
including: positive feedback on the proposed 800 mg BID Phase 3
dose and dosing regimen; confirmation of the use of a surrogate
primary endpoint focusing on rate of delivery less than 37 weeks
gestation rather on clinical infant outcomes; acknowledged that the
use of a gestational age endpoint would likely lead to Subpart H
approval as opposed to a full approval; and, recommended a
non-inferiority study margin of 7% with interim analyses. Lipocine
plans to submit the LPCN 1107 Phase 3 protocol to the FDA via a
Special Protocol Assessment (“SPA”) in the first half of
2017.
"We are appreciative of the clarity received from the FDA on the
critical clinical and regulatory requirements needed to advance
LPCN 1107 towards initiating the pivotal registration study,” said
Dr. Mahesh Patel, Chairman, President and CEO of Lipocine.
About LPCN 1107
LPCN 1107 is a novel oral product candidate in development for
the prevention of recurrent preterm birth in women with singleton
pregnancy. Potential benefits of Lipocine's oral product
candidate relative to current injectable products include:
the elimination of pain and site reactions associated with weekly
injections, elimination of weekly doctor visits or visits from the
nurse, and elimination of interference/disruption of personal,
family or professional activities associated with weekly visits.
LPCN 1107 has received orphan drug designation from the FDA.
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 FDA review process relating
to LPCN 1107, clinical trials related to LPCN 1107 and the related
FDA review process for LPCN 1107, the possible outcome and timing
of such clinical trials or FDA review process, the path to
approvability by the FDA of LPCN 1107 and other development
programs for LPCN 1021 and 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 1107 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:
John Woolford
Phone: (443) 213-0506
john.woolford@westwicke.com
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