Lipocine Validates “No Titration” Dosing Regimen With Positive Topline Efficacy Results for LPCN 1021, Oral Testosterone ...
June 19 2017 - 4:00PM
Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical
company, today announced results from both the Dosing Validation
(“DV”) and the Dosing Flexibility (“DF”) studies evaluating
efficacy and tolerability of LPCN 1021. LPCN 1021 is an 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
results from these studies confirm the validity of a fixed dose
approach without the need for dose titration to orally
administering LPCN 1021.
LPCN 1021 successfully met the FDA primary efficacy guidelines
in the DV study where 81% of the subjects achieved average
testosterone levels (“Cavg”) within the normal range with a lower
bound confidence interval (“CI”) of 72%. The DF study
restored 70% of the subjects’ average testosterone levels within
the normal range (Cavg) confirming that twice daily (“BID”) dosing
is the appropriate dosing regimen for LPCN 1021 and will be the
basis for resubmission.
The adverse event profile of LPCN 1021 in both the DV and DF
studies was consistent with the previously conducted 52-week Phase
3 Study of Androgen Replacement (“SOAR”) clinical trial. All
drug related adverse events (“AEs”) were either mild or moderate in
intensity and none were severe. To date, the safety database
of LPCN 1021 includes ~525 hypogonadal men demonstrating a profile
consistent with other TRT products.
The secondary endpoints assessed the maximum total testosterone
concentration (“Cmax”) post dosing using predetermined limits
developed by U.S. Food and Drug Administration (“FDA”) for
transdermals. Consistent with the definition of Cmax and the
pharmacokinetic profile of multiple times a day dosing, two
pre-specified analyses were performed, Cmax per dose and Cmax per
day.
In the DV study Cmax per dose analysis, the percentage of
subjects with Cmax less than 1500 ng/dL and between 1800 ng/dL and
2500 ng/dL were 85% and 7%, respectively. Deviations from the
predetermined limits in the DV study were observed in the Cmax per
day dose analysis for these thresholds. Only one subject, who
was a major protocol violator, exceeded the 2500 ng/dL limit
independent of per dose or per day dose analyses.
The DF study met all Cmax thresholds in per dose and per day
dose analyses.
“We are pleased with the confirmation of LPCN 1021 efficacy,
especially with a more practical patient and physician preferred
“no titration” dosing regimen. We believe the results should
address the label-related deficiency cited by the FDA in our NDA
submission," said Dr. Mahesh Patel, Chairman, President and CEO of
Lipocine Inc. Dr. Patel further stated, “We consider LPCN
1021 to be a differentiated TRT option for treating hypogonadism in
men with the potential to both improve patient compliance and
eliminate the risk of testosterone transference. We look
forward to resubmitting the NDA in the third quarter of
2017.”
About LPCN 1021
LPCN 1021 is an oral testosterone replacement therapy product
candidate containing Testosterone Undecanoate that is designed to
help restore normal testosterone levels in hypogonadal men.
Lipocine expects LPCN 1021 will help fulfill an unmet need in the
treatment of hypogonadism. The current testosterone market
primarily uses short-acting injectable products as well as topical
products that carry an FDA "black box" warning related to
inadvertent transfer of testosterone to others. Per the IMS Health
database, an average of 540,000 prescriptions a month have been
dispensed from January 2016 through December 2016 for testosterone
products.
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 1021, the DV and DF studies, including the efficacy of LPCN
1021 and whether the results will address the label-related
deficiency cited by the FDA in our NDA submission, the path to
approvability by the FDA of LPCN 1021 and the other development
programs for LPCN 1111 and LPCN 1107, the potential impact of LPCN
1021 on users and the timing and results of the resubmission of the
NDA. Investors are cautioned that all such forward-looking
statements involve risks and uncertainties, including, without
limitation, the risks that the FDA will not agree with our
conclusions from the DV and DF studies or approve LPCN 1021 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, risks related to the
possibility that the FDA will require an advisory committee meeting
with respect to LPCN 1021, 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:
Hans Vitzhum
Phone: (646) 597-6979
hans@lifesciadviors.com
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