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Lipocine Inc.
,
a specialty pharmaceutical company, today announced positive top-line results
from a Phase 2a clinical study of LPCN 1111, a novel testosterone replacement
therapy ("TRT") candidate, in hypogonadal males. The primary objective of the
study was to determine the feasibility of once daily dosing of LPCN 1111 in
hypogonadal males.
"We are pleased that the results in the hypogonadal subject population
confirmed our Phase 1 findings that LPCN 1111 is a candidate for once daily
oral testosterone replacement therapy," said Dr. Mahesh Patel, President and
CEO of Lipocine Inc. "Additionally, these results, along with our positive
top-line efficacy Phase 3 results for our lead asset, LPCN 1021, a twice-a-day
oral TRT, are particularly important in establishing Lipocine's leadership in
providing "best in class" patient friendly oral TRT options. We believe that
oral TRT will significantly increase patient compliance and overcome many of
the inconvenience and transference issues associated with today's marketed TRT
products."
This open-label, dose-escalating single and multiple dose study enrolled 12
males. These subjects had serum total testosterone < 300 ng/dL based on two
blood draws on two separate days. Subjects received doses of LPCN 1111 as a
single dose of 330 mg, 550 mg, 770 mg, followed by once daily administration
of 550 mg for 28 days in 10 subjects, and once daily administration of 770 mg
for 28 days in eight subjects.
Results from this study demonstrated the feasibility of a once daily dosing
with LPCN 1111 in hypogonadal men and a good dose response. Additionally, the
clinical study confirmed that steady state is achieved by day 14 with
consistent inter-day performance observed on day 14, 21 and 28. No subjects
exceeded peak serum testosterone concentration ("Cmax") of 1500 ng/dL at any
time during the 28 day dosing period on multi-dose exposure. Overall, LPCN
1111 was well tolerated with no serious adverse events.
Responder analysis for average 24 hour serum testosterone concentration
("Cavg") and Cmax from this study for the 550 mg dose and the 770 mg dose at
day 28 are shown below:
Responder analysis (Cavg and Cmax)
Typical FDA
Measure 550mg QD 770mg QD targets for
approval of
TRT
% subjects with C[avg] within normal range 67% 88% ≥ 75%
% of subjects with C[max ]≤1500ng/dL 100% 100% ≥ 85%
% of subjects with C[max ]between 1800ng/dL and 0% 0% ≤ 5%
2500mg/dl
% of subjects with C[max ]>2500ng/dL 0% 0% 0%
Based on these positive results, a Phase 2b study is planned to begin in the
first quarter of 2015 with the objective of determining the optimal once daily
dosing regimen of LPCN 1111.
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