SALT LAKE CITY, March 27, 2019 /PRNewswire/ -- Lipocine Inc.
(NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused
on metabolic and endocrine disorders, today announced findings from
the Ambulatory Blood Pressure Monitoring clinical study
(NCT03868059) ("ABPM Study") designed to study TLANDO's effects on
blood pressure. The objective of the ABPM Study was to characterize
blood pressure effects of TLANDO for appropriate U.S. Food and Drug
Administration ("FDA") regulatory action, including Risk Evaluation
and Mitigation Strategy ("REMS") beyond labeling.
The ABPM Study was an open label, single arm study that enrolled
144 male hypogonadal subjects undergoing four months of treatment
with TLANDO, 225 mg BID dosing, with 24-hour blood pressure
measurements taken at baseline and at the end of the
study. There were 138 subjects who received at least one dose
of study drug and 126 subjects completed the study. There
were 118 subjects enrolled in the ABPM Study with evaluable
weighted average 24-hour ABPM data at both baseline and at the end
of the study.
Subjects receiving treatment in the ABPM Study had
the following baseline parameters:
Baseline
Parameters
|
Mean (SD)
|
Age
(years)
|
53.8
(10.2)
|
BMI
(kg/m2)
|
33.1 (5.8)
|
24h SBP (mm
Hg)
|
127 (16)
|
24h DBP (mm
Hg)
|
79 (6)
|
SD = Standard
Deviation, BMI = Body Mass Index, SBP = Systolic Blood Pressure,
DBP = Diastolic Blood Pressure
|
Additionally, among the subjects enrolled in the ABPM Study, 48%
of the subjects were hypertensive and 24% of subjects were type 2
diabetic.
Top-line results from the ABPM Study are as follows:
Parameter
|
Mean Change, mm Hg
(95% CI)
|
24-hour
SBP
|
3.82 (1.69,
5.96)
|
24-hour DBP
|
1.20 (0.31,
2.08)
|
CI = Confidence
Interval, SBP = Systolic Blood Pressure, DBP = Diastolic Blood
Pressure
|
Of the subjects (n=25) with baseline 24-hour average systolic
blood pressure ("SBP") greater than 140 mm Hg, 32% of the subjects
were less than or equal to 140 mm Hg at the end of study.
Additionally, of the subjects (n=93) with baseline 24-hour average
SBP of less than or equal to 140 mm Hg, 9.7% of the subjects were
greater than 140 mm Hg at the end of study.
In the Study of Oral Androgen Replacement clinical study
(NCT02081300) ("SOAR"), 0.96% of the subjects required a change to
their anti-hypertensive medication regimen following one-year of
treatment with TLANDO. No subjects were started on a new
anti-hypertensive drug during the SOAR study.
Consistent with safety results from twelve previously completed
clinical trials, TLANDO was generally well-tolerated in the ABPM
Study with no drug-related Serious Adverse Events ("SAEs"), no
Major Adverse Cardiac Events ("MACE") or deaths.
"We are pleased with the TLANDO pressor results which we believe
are in line with a recently approved testosterone replacement
therapy. We look forward to resubmitting our NDA in the second
quarter of 2019," said Dr. Mahesh
Patel, Chairman, President and Chief Executive Officer of
Lipocine. Dr. Patel further stated, "We remain committed on
bringing our patient-friendly oral testosterone product candidate
to patients in a timely manner."
About Lipocine
Lipocine Inc. is a clinical-stage
biopharmaceutical company focused on metabolic and endocrine
disorders 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. LPCN 1144, an oral product of bioidentical
testosterone, recently completed a proof-of-concept clinical study
demonstrating the potential utility in the treatment of NASH. 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 clinical trials
including the ABPM Study, the timing of completion of clinical
trials, the timing for resubmission of our NDA for TLANDO, 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.
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SOURCE Lipocine Inc.