Lipocine Announces Submission of SPA on LPCN 1107, an Oral Alternative for the Prevention of Preterm Birth
June 26 2017 - 8:00AM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company,
today announced that it has submitted a Special Protocol Assessment
(“SPA”) request to the U.S. Food and Drug Administration
(“FDA”), as part of the ongoing interaction with the FDA on
the detailed design of the planned Phase 3 clinical development
program for LPCN 1107 for prevention of recurrent preterm birth
(“PTB”) with history of singleton pregnancy. An SPA is an advanced
declaration from the FDA that a planned trial's design, clinical
endpoints, and statistical analyses could potentially result in
data acceptable for FDA review towards approval for the proposed
indication.
The proposed Phase 3 clinical trial has been designed as an
adequate and well-controlled non-inferiority trial comparing LPCN
1107 with Makena®, the current standard of care for PTB.
Based on prior interactions with the FDA, Lipocine has
proposed an efficacy endpoint focusing on the rate of delivery at
less than 37 weeks gestation. Success on this gestational age
endpoint could lead to Subpart H approval by the FDA. The
proposed enrollment population is singleton pregnant women with a
history of singleton spontaneous preterm birth. The proposed
trial has an adaptive design with an interim analysis.
"We have submitted an SPA request to the FDA with the goal of
solidifying the development and regulatory pathway for LPCN 1107,
and specifically, the details of our planned Phase 3 clinical
trial," said Dr. Mahesh V. Patel, Chairman, President and CEO of
Lipocine. “Prevention of PTB is a significant unmet need with
approximately 11.7% of all U.S. pregnancies resulting in this
outcome (delivery less than 37 weeks). It is a leading cause of
neonatal mortality and morbidity.”
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, a novel oral
prodrug of testosterone containing testosterone undecanoate, is
designed to help restore normal testosterone levels in hypogonadal
men. LPCN 1021 was well tolerated and met the primary efficacy
end-points in Phase 3 testing with twice daily dosing. 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, 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 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 FDA review process relating
to LPCN 1107, clinical trials related to 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.
Makena® is a registered trademark of AMAG Pharmaceuticals,
Inc.
CONTACT:
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
mb@lipocine.com
Investors:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
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