Full Press Release Details
Lipocine Files IND To Evaluate LPCN 1144
In Biopsy Confirmed NASH Subjects
LAKE CITY, UT, January 23, 2019 - Lipocine Inc. (NASDAQ: LPCN), a specialty
pharmaceutical company, today announced that it has filed an Investigational New Drug application ("IND") with the
U.S. Food and Drug Administration ("FDA") to initiate a Phase 2 clinical study of LPCN 1144 in non-alcoholic
steatohepatitis ("NASH") with biopsy confirmed NASH subjects.
"This IND filing is an important
step forward as we pursue further evaluation of LPCN 1144 in biopsy confirmed NASH patients for the treatment of NASH. There is
currently no FDA approved product for the treatment of NASH and we believe our well-tolerated oral LPCN 1144 is well positioned
to mechanistically address this disease and provide additional unmet benefits," said Dr. Mahesh Patel, Chairman, President
and Chief Executive Officer of 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 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 current and future clinical
trials including the liver fat imaging study with LPCN 1144, the timing of completion of clinical trials including the ongoing
LPCN 1144 clinical trial, 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.
Executive Vice President & Chief
Phone: (801) 994-7383
Phone: (617) 535-7743